Tuesday, October 9, 2012

Dr. Alan Lewis takes the reins as Medistem's new CEO

Dear Friends and Colleagues,

It is my great pleasure to announce that our company Medistem has been fortunate to recruit a leader in the field of drug development to join us as CEO. Dr. Alan Lewis has grown companies to the point of exit in our space, as well as led the Juvenile Diabetes Research Foundation (JDRF), the largest supporter of diabetes research. Most importantly, Alan has watched Medistem grow since my joining in 2007, when I would periodically seek his advice on corporate direction and strategy. I will work closely with Alan in the position of President and Chief Scientific Officer.

Below please find the press release that we issued today.



Thomas Ichim, Ph.D
President and Chief Scientific Officer

Medistem Inc
9255 Towne Centre Drive
Suite 450
San Diego
CA 92121

858 349 3617
twitter: @thomasichim

Biopharmaceutical Executive Dr. Alan Lewis Appointed as CEO of Medistem
World-Class Industry Expert to Accelerate Commercialization of Universal Donor Stem Cell Drug for Heart Failure, Critical Limb Ischemia and Type 1 Diabetes

SAN DIEGO, CA--(Marketwire - Oct 9th 2012) - Medistem Inc. (PINKSHEETS: MEDS) announced today appointment of Dr. Alan Lewis to the position of Chief Executive Officer and Member of the Board. Since January, Dr. Lewis has been functioning in the capacity of Scientific Advisory Board Member for Medistem.

"We are enthusiastic that Dr. Lewis is taking the helm to help accelerate clinical development of the Endometrial Regenerative Cell (ERC) universal donor stem cell product, which is already a Phase I and Phase II studies for critical limb ischemia and congestive heart failure, respectively." Said Dr. Vladimir Bogin, Chairman of Medistem. "Dr. Thomas Ichim is assuming the role as the company's President and Chief Scientific Officer."

Dr. Lewis spent 15 years at the pharmaceutical company Wyeth-Ayerst, where he was Vice President of Research, leading translational research efforts in diabetes, CNS, cardiovascular, inflammatory, allergy and bone metabolism diseases. He subsequently became CEO of Signal Pharmaceuticals, a drug development company that he successfully merged with Celgene. He became CEO of Novocell Inc (Viacyte) and subsequently served as CEO of the Juvenile Diabetes Research Foundation, the largest research funding body for diabetes. Most recently he was CEO of Ambit Biosciences. He currently serves on the board of BioMarin (BMRN) and a number of private biotechnology companies.

"To date the Medistem team has demonstrated remarkable accomplishments by taking a stem cell from discovery to FDA clearance in the short span of 4 years; thus positioning the company as having the longest patent life among clinical-stage stem cell companies." Said Dr. Lewis. "In contrast to other types of stem cells, Medistem's ERC appears to be the most potent at stimulating production of new blood vessels. In addition, ERC's proven ability to differentiate into multiple tissue types has a potential to treat numerous indications."

Medistem has licensed intellectual property from Yale University related to using ERC to treat Type 1 Diabetes, which the company plans to develop into its third area of clinical trials.

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and congestive heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Medistem Inc.
Thomas Ichim
President and Chief Scientific Officer
twitter: @thomasichim

Monday, October 1, 2012

Salute to Courage: Stem Cell Recipient Chris Niles earns award for his inspiration

Chris underwent stem cell therapy for spinal cord injury at the Stem Cell Institute in Panama City, Panama. It's great to see he's doing so well. Go Chris!

Patrick E. Litowitz
New Castle News

NEW CASTLE — A physician wanted to be clear with his patient — he would never walk again. The doctor repeated himself.

Chris Niles heard him the first time and knew he was moving forward regardless of the prognosis. The tree that crushed his spine on March 3, 2011, in the back yard of his Hickory Township home created a detour in his life. It didn’t end it.

Niles’ foundation of strength comes from numerous sources: his wife, Jennifer, and two sons, Christopher and Braden; family, friends and strangers; intense physical therapy; and stem cell treatments.

“Chris’ courage amazes me,” Jennifer said. “He still wakes up and faces every day with smile.”

Initially, he was paralyzed from his shoulder blades down. Today, the improvement has extended along the spinal cord to L1 vertebrae, the area near the large intestines. His feet and hip flexors contract, although he doesn’t control their motions. Then there are the tingling and burning sensations he feels in his lower extremities.

Along the journey, his willpower inspires others.

“He is a rock to many people without even knowing,” Jennifer said. “He makes this life look easy because he wants to prove to the world life can go on.”

Last night, her husband was honored as the New Castle Community YMCA’s Salute to Courage award recipient. A dinner in his honor took place at the Villa Banquet Center. The annual award goes to a Lawrence County resident demonstrating courage in recovering from an accident, injury or illness, in living with a disability or through an act of heroism, according to the Y.

More than 350 people attended.

“Chris got contagious,” his brother-in-law Raymond Omer said. “The fact that he has the injury is part of his motivation.

“This whole thing serves as an inspiration to this county. It’s awakened people that we are our brothers’ keepers.”

Chris’ lifelong friend, Carlo DiNardo, said he didn’t pity himself when the accident occurred.

“From Day One, whether he’s going to walk again or not, Chris is going to be OK. He’s not going to throw in the towel. … He can’t give up.

“He started thinking ahead — ‘Now what am I going to do?’ It wasn’t something that stopped him from life.”

Carlo said his friend’s drive is phenomenal.

“He wants to go to work. He wants to be a productive member of society. He also wants to give back.”

Raymond said assistance has come in layers. His family and friends remained steadfast in their support.

“Immediately after the injury, it was those people who had the most intimate relationship with Chris — people he worked with, people he saw every day.

“Now, we have those added layers of people who see this as a story of inspiration that want to participate in some way in Chris’ story. Their assistance is providing relief to those who were with Chris since that day of his injury.”

Although treatments will continue, Raymond and Carlo said Chris wants to take the attention away from him.

“We’re awestruck by the acts of kindness of the Lawrence County community and beyond,” Raymond said. “We’re ready to take this to the next step.

“Chris said to me, ‘I want to shut this down. I’m ready for my name and my fund to go to start helping other people.’ ”

Thursday, September 20, 2012

Your Body's Stem Cell Bank Account

By Neil Riordan, PhD

Everybody is born with a certain amount of stem cells, specifically, "adult stem cells." This number may be thought of as a type of "bank account", from which each person may make "withdrawals" throughout his or her lifetime, as needed.

However, not all bank accounts are created equal. To continue with the analogy, some people are born rich, while others are born poor. Most people, however, may be thought of as "middle class." This fact helps to explain why some people are able to enjoy health and longevity despite very unhealthy lifestyles, while other people may enjoy neither robust health nor longevity despite healthy lifestyles. In other words, some people are able to "spend" their stem cells more extravagantly than others, simply because they have more to spend. Most of us, however, fall somewhere in the middle, where both the length and the quality of our lives may be influenced to some degree by our choice of lifestyle. Environmental factors also play a key role in determining how rapidly one's "bank account" of (adult) stem cells is depleted. However, even under ideal circumstances, stem cells continually diminish with age.

Our stem cells exist in every part of the body to repair damage, such as from broken bones, a paper cut, radiological or chemical exposure, etc., all of which require stem cells for healing. You may draw on your bank account at any time, whenever you need to do so, until you run out of stem cells. As your "bank account" of stem cells approaches zero, physiological healing will become increasingly difficult, until finally it ceases altogether.

Utilizing stem cells is like going to the ATM machine. Depending upon how you live your life, and whether you were born with a large or a small bank account of stem cells, you either may or may not be able to withdraw from your account. If you were fortunate enough to be born with a large amount of stem cells, then you might possibly be able to smoke and drink and eat unhealthy food and never exercise, and still live to a ripe old age, because regardless of how many stem cells you expend, there are still more to be spent.

On the other hand, if you were born at the opposite end of the spectrum, with a small amount of stem cells, then an unhealthy lifestyle will have a more immediate and detrimental impact upon the quality and length of your life. This is known as Nature's Law of Conservancy: the less stem cells that exist in your "account", the more stingy the ATM machine becomes in distributing the contents of that account. Most people, however, are born into the stem cell "middle class", which is to say that lifestyle choices can often make a noticeable difference in determining health and longevity.

When someone has a large number of stem cells in the bank, the ATM works very quickly and efficiently. But when the bank account is almost empty, which ordinarily happens in the latter years of life, the ATM machine does not distribute the stem cells as readily. In biological terms, this is because the division rate of the cells has slowed considerably. Simply changing the doubling time of stem cells from 24 hours to 72 hours can make a 90-day difference in the amount of time required to reach a "critical mass" of cells that are required to heal a wound. Michael Andreeff, M.D., Ph.D., a professor in the Departments of Blood and Marrow Transplantation and Leukemia Cancer at M.D. Anderson, has described cancer as a "never healing wound"; in some cases, the doubling time of the stem cells may never be fast enough to "catch up" and heal the wound. This is why the incidence of cancer increases with age. After childhood cancers (which arise due to genetic factors or to overwhelming environmental exposure), the incidence of cancer drops significantly until around the age of 40, when it starts to increase, shooting up dramatically around the age of 50, and then falling again around the age of 65.

When someone has fully depleted his or her stem cell reserve, the only possible way to get more stem cells is from an alternate source. This is where stem cell therapy comes into play.

Salamanders are a supreme example of stem cell billionaires. Salamanders have a seemingly unlimited supply of stem cells, as their "bank accounts" are virtually incapable of being depleted. If you were to look at the blood of a salamander under a microscope, you would see that all of the red blood cells (RBCs) are nucleated. In other words, all RBCs of a salamander contain nuclei, unlike human RBCs, which are not nucleated. This is why salamanders can regenerate entire limbs and humans cannot: every RBC in a salamander is a functional stem cell, floating around everywhere throughout the salamander's body. In humans, by contrast, our RBCs cannot replicate themselves once they have migrated out of our bone marrow. As long as the salamander is still alive, its ATM machine is fast and generous in distributing as many stem cells as may be needed for any task.

Although humans are not salamanders, the ability to regenerate entire limbs nevertheless offers a powerful example of the possible applications and implications of stem cells. Practically as well as theoretically, an enormous, mostly untapped, potential exists in the field of stem cell therapy.

Inflammatory Bowel Disease Treatable With Stem Cells?

Researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine may have discovered the key to treating inflammatory bowel disease (IBD).

Dr. Graca Almeida-Porada and her team of scientists found a specific stem cell population in cord blood that migrates to the intestine and proliferates there.
Fetal sheep were injected with the stem cells and their intestines were analyzed 11 weeks later.

"These cells are involved in the formation of blood vessels and may prove to be a tool for improving the vessel abnormalities found in IBD," said Dr. Almeida-Porada.

Intestinal swelling, inflammation and ulcers typically cause abdominal pain and diarrhea in IBD patients. Reducing inflammation is a key to treatment but currently approved drugs are not very effective.

"This study shows that the cells can migrate to and survive in a healthy intestine and have the potential to support vascular health," said Almeida-Porada. "Our next step will be to determine whether the cells can survive in the 'war' environment of an inflamed intestine."

Friday, September 14, 2012

Stem cell treatment in Panama benefits autistic Glenburn youth

By Dale McGarrigle, Of The Weekly Staff
Bangor Daily News
Posted Sept. 14, 2012, at 12:17 p.m.

GLENBURN — Now Kenny can read.

Kenny Kelley can now also do many things that other 11-year-olds take for granted. According to his mother, Marty Kelley, that’s because injections of adult stem cells, taken from umbilical cord blood, have helped Kenny to shake off the shackles of autism, with which he was first diagnosed at age 2.

“The results from stem cells can be seen everyday in his amazing thoughts and vast imagination!!,” Marty Kelley wrote in her blog, http://www.kensjourneytorecovery.blogspot.com/. “How lucky we are for such a miracle treatment!”

Autism is a brain disorder found in children that interferes with their ability to communicate and relate to other people. Autism affects 1 in 88 children and 1 in 54 boys. What causes autism has not been established.

Stem cells are the body’s internal repair system and can fix and replace damaged tissue. These unspecialized cells are a blank slate, capable of transforming into muscle cells, blood cells, and brain cells. Stem cells can also renew themselves by dividing and giving rise to more stem cells.

Stem cells taken from umbilical cord blood, such as Kenny received, are the least likely to be rejected.

The stem-cell treatment is the latest effort by Marty and her husband, Donald, to find ways to improve Kenny’s life. The Kelleys also have two other children: Philip, 13, and Caroline-Grace, 6.

First was in-home treatment in a mild hyperbaric oxygen chamber, three hours a day equaling 800 hours over the course of two years, beginning when Kenny was 5 ½ to 6 years old. This was coupled with a Specific Carbohydrate Diet, which restricts the use of complex carbohydrates and eliminates refined sugar and all grains and starch from the diet.

“We saw results right away with the chamber,” Marty recalled in a recent interview. “He made slow gains, such as tracing the alphabet.”

Then the Kelleys discovered on the Internet the story of Matthew Faiella, a New York boy who has been making great strides after stem-cell treatment in Panama for his autism. They decided to follow suit.

Why take this path, when there has been little scientific research into the use of stem cells to treat autism?

“We were willing to do it as long as it’s safe, and I’ve researched this,” Marty said. “Stem cells are very natural. I’m not a scientist, but I care much more than any scientist would, and I would never do anything to hurt my baby.”

When Kenny went for his first stem-cell treatment in July 2009, at the Stem Cell Institute in Costa Rica, Marty assessed the condition of her then 8-year-old son in her blog http://www.kensjourneytorecovery.blogspot.com:

• Behavior: Screaming, aggressive, giggles/silly/inappropriate with his brother or new people, running around, destructive, uncooperative while being dressed, hitting, not potty trained (still wearing diapers).

• Speech: Vocabulary of a 4-year-old. He can talk, but it is difficult for strangers to understand him. Answers some questions, but he does not understand or like why, when, or how questions.

• Physical: A body the size of a 5-year-old boy.

Kenny has had stem-cell treatments in 2009, 2010, and May and November of 2011. The repeated treatments are required because adult stems cells will work repairing cells for a period of time, about six months, then leave the body.

“When I think I’ve seen his skills level out, we’ll go for another treatment,” explained Marty.

What are some of the changes that Kenny has undergone in the past three years? First came the ability to read and clearer speech.

“When he got back, he just picked up a book and started reading, and I could understand every word,” said Mike Hughes, Marty’s brother. “It was like a light just turned on.”

Other gains: Kenny is talking about past events for the first time, and he’s conversational now. He expresses opinions and looking ahead to the future. He was finally potty trained at age 9. He’s doing math now. He’s calmed down considerably. This summer, he went to summer camp, staying overnight for three nights, in the same cabin as Philip.

“There’s no doubt in my mind how much he’s progressing,” Marty said. “We’re working on catching up right now, and how do we best do that?”

The costly treatment, which isn’t covered by insurance, hasn’t been approved yet by the Food and Drug Administration. Despite the fact that the stem cells come from the human body, the cells are considered a new drug by the FDA and are subject to stringent research and testing that can take years.

So this leaves the Kelleys and others like them seeking stem-cell treatment, going overseas to get it.

“It’s just a matter of how much are you going to spend,” Marty said. “There’s no treatment here that was going to do this much for him.”

Thursday, September 13, 2012

Medistem Advances Type 1 Diabetes Stem Cell Technology Licensed From Yale

SAN DIEGO, CA -- (Marketwire) -- 09/12/12 -- Medistem Inc. (PINKSHEETS: MEDS) announced today completion of the first phase of a joint project with the Shumakov Research Center of Transplantology and Artificial Organs of the Russian Federation and its Russian and CIS licensee ERCell. The collaboration is based on using Endometrial Regenerative Cell (ERC) technology licensed from Yale University to treat type 1 diabetes.

Dr. Viktor Sevastianov, Head and Professor of the Institute of Biomedical Research and Technology, within the Shumakov Center, demonstrated safety and feasibility of ERC injection in experimental animal models of diabetes. Additionally, the studies demonstrated that the cell delivery technology developed by Dr. Sevastianov's laboratory can be used to enhance growth of ERC. These experiments are part of the process for registration of "new pharmacological substances," which is the first step towards drug approval in Russia.

"Type 1 diabetes is a significant problem in the Russian Federation. Our laboratory has been working developing various delivery formulations for cell therapy, such as SpheroGel, which is registered in Russia," said Dr. Sevastianov. "Given that the ERC can be produced in large quantities, is a universal donor cell, and already is approved for clinical trials in both the USA and Russia, we are optimistic our collaboration will lead to a viable commercial product for the type 1 diabetes Russian population."

Medistem discovered ERCs in 2007, and they appear to possess "universal donor" properties, allowing the cells derived from one donor can treat multiple unrelated recipients. According to Medistem's current FDA cleared production scheme, one donor can generate 20,000 patient doses. Medistem licensed technology from Yale University for generating insulin producing cells from ERC. A publication describing the technology may be found at http://www.ncbi.nlm.nih.gov/pubmed/21878900.

"Our vision is to combine SpheroGel, which is a clinically-available cell delivery vehicle in Russia, together with Medistem's ERC and technology from Yale University to generate a commercially-viable product for clinical trials in type 1 diabetes patients," said Thomas Ichim, CEO of Medistem.

Medistem has outlicensed the Russian and CIS rights to ERC and related products to ERCell LLC, a St. Petersburg-based biotechnology company. Under the agreement, Medistem owns all data generated and will receive milestone and royalty payments.
"By working with leading investigators in Russia and the USA, we seek to be the leaders in a new era of medicine in Russia," said Tereza Ustimova, CEO of ERCell."

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Contact: Thomas Ichim Chief Executive Officer Medistem Inc. 9255 Towne Centre Drive Suite 450 San Diego, CA 92122 858 349 3617 www.medisteminc.com twitter: @thomasichim
Source: Medistem Inc.

Monday, September 10, 2012

Adipose (Fat) Stem Cell Counting Methods Can Lead to Inaccurate Dosing

David G. Morrison, Dirk A Hunt, Isaac Garza, Robbie A. Johnson, Mary Pat Moyer*
INCELL Corporation LLC www.incell.com
12734 Cimarron Path, San Antonio, TX 78249

*Corresponding Author Contact information: mpmoyer@incell.com; 210.877.0100


There has been considerable interest in stem cell treatment of humans and animals for osteoarthritis and other conditions in recent years. Quality and accuracy of the methods of isolation and counting of cells for therapeutic dosing is of great concern to practitioners whether their patients have two or four legs. INCELL Corporation is a GMP cell therapy manufacturer of human tissue derived cells and has extensive experience isolating stem and stromal vascular cells from fat removed from humans and many animal species.

INCELL is actively evaluating process methods to improve quality and quantity of cell therapy preparations, such as mammalian stromal vascular fraction (SVF) including stem cells isolated from adipose tissues. Intrigued by the high cell numbers (5 to 20 million cells/gram1-3) reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 4-6), INCELL staff conducted a research study to investigate the high apparent yield of stem cells. This initial work was focused on SVF cells from the MediVet Kit, which is marketed to isolate adipose-derived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods. These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine4, Vidal–equine5, Yoshimura–human6). Since these cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher. If the numbers are accurate, this would be process improvement, but if they are inaccurate, then there is a risk of incorrect cell numbers that will impact therapeutic dosing by the practitioner and/or biorepository storage. Particularly important are the numbers of renewable, replicating cells that grow out in culture as attached fibroblastoid (F) cells and are quantified colony-forming units (CFU-F). When recommended processing methods and commonly used counting methodologies are compared to CFU-F results from the same processed tissue counting errors are evidenced as differences in CFU-F numbers.

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All kit procedures were followed as per the instructions provided. A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below.
INCELL White Paper: Stem Cell Counting Methods Can Lead to Inaccurate Dosing


The Cellometer (Nexcelom Biosciences, Lawrence, MA) is commonly used for cell counting and is recommended for use by MediVet. It uses a two-part dye that counts by staining DNA in live cells green with acridine orange (AO) and dead cells red with propidium iodide (PI) at the same time. The problem with using AO staining as an indicator of living cells is that background lipid micelles auto-fluoresce green and would be detected as AO stained cells. Emulsifying agents used in these methods (such as Solution E in the kit), when mixed with water, can form a myriad of small fat droplets, called micelles or liposomes. Figure 1 shows that kit-recommended settings on the Cellometer overestimated mean SVF live cell counts compared to other methods investigated. The higher Cellometer counts are at least partially explained by the machine counting the micelles. As part of the reagent cross-check, Solution E (emulsifying agent) from the tested kits was evaluated without adding any adipose tissue or SVF. The Cellometer counted the micelles as “cells” (Figures 1 and 2), leading to erroneous cell counts due to the Solution E micellular structures. In order to completely differentiate these background lipid particles from live cells in any cell therapy product, methods to specifically identify cell nuclei are required.

Figure 1. Mean Nucleated Cell Counts per Gram of Adipose Tissue

Legend: Mean (+ SD) nucleated cell counts per gram of adipose tissue are shown for four different counting methods from 3 dogs, with counts in triplicate. Additionally, the Cellometer count for Solution E without any cells is shown. The Solution E count accounts for nearly 75% of the inflated Cellometer SVF counts and demonstrate that most counts shown by the Cellometer are not cells. When the NucleoCounter was used to count Solution E (data not shown), it found no cells because of a lack of any nuclei to stain with PI. Using the Cellometer with the AO dead/alive program recommended by MediVet, the machine counted micelle bodies as cells because it was unable to differentiate between the green autofluorescence of the micelles and the green AO staining that would have been present if there were any cells in the sample. Overall, the Cellometer reported a cell count approximately 5 to 16 times higher than the manual cell counts.

Coulter-type Counters. An alternative method recommended in the instructions to the kit is cell counting on a clinical hematology analyzer. Coulter counter methods measure the electrical impedance as cells pass between electrodes. Cells and micelles would have similar impedance, leading to the high cell count seen in clinical Coulter-type counters. A Heska HemaTrue counter was evaluated in this study (Figure 1). That work was done off-site and immediately at a local veterinary practice within 0.2 miles of the INCELL offices.

NucleoCounter. A common automated counter used with SVF cells is the NucleoCounter (ChemoMetec; Denmark). This counting machine and method is based on staining cell nuclei with PI dye. The NucleoCounter uses a two-stage process to achieve a viable SVF cell count, and counts are not greatly affected by the presence of micelles. The cell counts from the NucleoCounter are more in line with the manual hemocytometer counts and more closely reflect the outgrowth of live cells in culture as colony-forming units (CFU below). The NucleoCounter method has been reported in the literature by human adipose stem cell companies (e.g. Cytori, San Diego, CA) and by at least one veterinary stem cell company (Vet-Stem, Inc., Poway, CA) as being an accurate automated counting method for SVF cells.

Hemocytometer. SVF cells were also counted manually using a hemocytometer with a combination of DAPI (blue wavelength fluorescent nuclear stain) and trypan Blue (dye excluded by viable cells) staining by overlaying the digital light images and DAPI fluorescent images taken on a fluorescent microscope and counting the DAPI-stained nuclei in cells that excluded Trypan Blue (Figures 1 and 2). This provides an approximation of the “true” nucleated, live cells in a population. This is the method used to visually reduce errors of counting non-cellular materials as cells. However, it requires specialized expertise and training, and an imaging fluorescence microscope to clearly distinguish cells. It also takes considerable time for each sample.

Figure 2. Micrograph of Isolated SVF cells by the MediVet Method

Legend: This photomicrograph (bar=200 microns) shows the final SVF preparation from the MediVet kit process and what looks like a dense covering of cells. most of the small cell-like structures, however, are lipid droplets or micelles. These are carried into the cell preparation, have green autofluorescence and appear to the Cellometer as countable units, which may explain why the reported cell numbers from this method are higher than other industry or academic reports.

Colony-Forming Unit Assay (CFU). assays were also done as a measure of the number of stem cells in the population. In this assay, a defined number of SVF cells were placed in culture plates and allowed to attach and grow into visual colonies (also known as a “CFU-F” assay). While only a subset of viable cells in the SVF will attach to the plastic dishes and form colonies, the CFU assay provides a good index for proliferative potential. Thus, the outgrowth of renewable stem cells as measured by CFUs comprises a fraction of the population. As expected, there was variability between animals and counting methods. The highest percentage was 8 to 10% of the cells seeded in the NucleoCounter counts and in all cases the Cellometer CFUs were lower for each dog tissue donor and overall (Figure 3). The differences in CFUs between methods were statistically significantly (p<0.05) in all animals and in the overall composite results comparing the NucleoCounter and the Cellometer. The lower CFU observations did not correlate with higher numbers of cells (Figure 1). This led to the conclusion that the cell numbers in the Cellometer are an overestimate, since the source tissue processed SVFs which were used for the counts are the same.

Figure 3. Cell Counting Methods and CFU-F of Seeded Cells

Legend: SVF cells were obtained for dog donor fat samples (N=3; 3 replicates) processed according to Medivet kit instructions. The resultant SVF cells were counted by a variety of methods. Cells were seeded into complete MSC culture medium for CFU studies with cell numbers for seeding designated according to two of the counting methods used: NucleoCounter (blue) and Cellometer (brown). After the colonies formed, they were counted and calculations were done to determine the Mean +/- SEM numbers of CFU-F per 200,000 cells seeded. These data were calculated for each individual dog and for All pooled data with each counting method. Statistical analyses (Students t tests for NucleoCounter vs. Cellometer) between the 2 counting methods showed statistical significance at p<0.05 for the individual dogs and overall.

Light Activation. As part of evaluating process improvements, Platelet Rich Plasma (PRP) in concert with the Medivet light activation, as per the kit instructions, was used to assess the increase of cell viability and the ability to form colonies in CFU assays as reported by MediVet1. Figure 4 results clearly show that light activation did not increase the number of stem cells or increase their ability to proliferate as measured by CFU assays in this study. In fact, 2/3 dog donors showed significant reductions in percent CFU after the exposure to the light activation system, whereas Dog #2 was essentially unchanged (Figure 4). Reasons for the variability and this unexpected result were not investigated further.

Figure 4. Colony Forming Units and Light Activation

Legend: Percent CFU-F assays show estimates of stem cell content/activity from a sample taken before (left columns) and a sample taken after (right columns) the MediVet light activation step. Data show that exposure to the light activation system resulted in a reduction in the mean number of colonies in Dogs #1 and #3 and no real difference in Dog #2. The average reduction in %CFU across all groups was approximately 34%.

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use. The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that can lead to incorrect cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be erroneously counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used.

In this study the most inaccurate counting came from the Cellometer. When used according to kit-recommended guidelines and on-site training provided by Nexelcom for counting cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting. The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and is not suitable for routine clinical use.

The SVF was shared among the counting and test methods. Thus, the post-processing numbers of stem cells would be the same and cell numbers should directly correlate with CFU-F per cell numbers seeded if the cell counts are accurate. Lower CFU numbers than expected from the cell counts would directly demonstrate an error in the cell counting method. To that end, the CFU-F results for the NucleoCounter showed 2.5X to about 20X higher CFU-F than the Cellometer leading to the conclusion that the Cellometer counts are high and incorrect. Also, in this study the percent CFU was reduced or there was no change after light activation, demonstrating no benefit or a detrimental effect of this step. Significantly fewer cells suggested that a death pathway may have been induced by the light treatment in 2 of 3 dog donors, but further studies are needed to clarify the proposed mechanisms of action and the controlling factors of the outcomes. These might include clinically relevant features of the donor dogs, or equipment or technical issues.

Other companies also have claims of very high cell numbers when their processes are used. Adistem2, like MediVet1, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular liposome structures and to disrupt and lyse cells, is another potentially problematic procedure for counting and verifying viable, regenerative cells. Intellicell3 uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers. This assumption could be verified with additional studies.

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on specific cell numbers as a treatment dose. Hopefully, this study will lead to more reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes, more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

1 http://www.MediVetlabs.com/cellcounts.html; accessed June 21, 2012.
2 http://www.adistem.com/science-and-technology.htm
3 http://www.intellicellbiosciences.com/intellicell-facts.html
4 Chung D, Hayashi K, Toupadakis A, et al. Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia. Res Vet Sci, 2010; 92(1):66-75.
5 Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622
6 Yoshimura K, Shigeura T, Matsumoto D, et al: Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate. J Cell Phys, 2006; 205:64-76.

This study was performed as independent research by INCELL staff, but was funded in part by Personalized Stem Cells, Inc., Ramona, CA and VetStem, Inc. INCELL is not involved in the clinical veterinary stem cell business, but does provide services for veterinary and human R&D, contract manufacturing, and stem cell services to the human stem cell industry.

Medistem Panama - Inside our adult stem cell laboratory || Video

• Learn how cord blood stem cells, cord tissue stem cells and stromal vascular fraction cells (fat stem cells and T-regulatory cells) are processed in our GMP and GLP compliant lab.

• See inside our 3 class 10,000 clean rooms and 8 class 100 laminar flow hoods.

• Discover what mesenchymal stem cells, CD34+ stem cells and endometrial stem cells look like under the microscope.

Learn more about stem cell therapy in Panama

Friday, August 31, 2012

Giving Birth after Stem Cell Treatments for Spinal Cord Injury || Video

Trish Stressman and her husband Scott discuss how stem cell therapy at the Stem Cell Institute in Panama allowed her to recover to the point at which she could safely give birth and care for her newborn daughter, Savannah Hope.

Prior to stem cell treatment, Trish had no core muscles and would not have been able to even safely hold a baby, let alone care for one. Since stem cells, that's all changed. Congratulations Trish, Scott and Savannah Hope!

See more of Trish's uplifting story here: http://youtu.be/zgSB1PtbiZg

Tuesday, August 28, 2012

Blood Stem Cells Permanently Damaged by Alcohol

Bone marrow stem cells are extremely sensitive to the primary by-product of alcohol, which causes permanent damage to their DNA claims researchers from the Medical Research Council (MRC) Lab of Molecular Biology.

The research, which was conducted on mice, uncovers two mechanisms that normally control this type of damage; a protein group that recognizes and repairs DNA damage and an enzyme that eliminates acetaldehyde, alcohol's toxic breakdown product.

Mice lacking both protective mechanisms developed bone marrow failure stemming from blood stem cell damage.

These results mark the first time that scientists have been able to explain why bone marrow fails in Fanconi anemia (FA) patients. FA is a rare genetic disorder.

The report concludes that FA turns off the bone marrow's "repair kit" via FA gene mutation which causers DNA damage from acetaldehyde to continue unchecked. This damage is responsible for bone marrow failure and developmental defects in FA patients and makes them especially vulnerable to blood and other types of cancer.

These findings may have particular significance for the world's Asian population, many of whom suffer from "Asian flush syndrome". People with AFS lack the enzyme ALDH2 and therefore could be particularly susceptible to DNA damage. The authors warned that this subset of the Asian population could suffer permanent DNA damage with alcohol consumption and be more highly prone to blood cancer, bone marrow failure and premature aging than the Asian population at-large.

"Blood stem cells are responsible for providing a continuous supply of healthy blood cells throughout our lifespan. With age, these vital stem cells become less effective because of the build up of damaged DNA. Our study identifies a key source of this DNA damage and defines two protective mechanisms that stem cells use to counteract this threat. Last year we published a paper showing that without this two-tier protection, alcohol breakdown products are extremely toxic to the blood. We now identify exactly where this DNA damage is occurring, which is important because it means that alcohol doesn't just kill off healthy circulating cells, it gradually destroys the blood cell factory. Once these blood stem cells are damaged they may give rise to leukaemias and when they are gone they cannot be replaced, resulting in bone marrow failure," Dr KJ Patel, who is the primary investigator.

"The findings may be particularly significant for a vast number of people from Asian countries such as China, where up to a third of the population are deficient in the ALDH2 enzyme. Alcohol consumption in these individuals could overload their FA DNA repair kit causing irreversible damage to their blood stem cells. The long-term consequences of this could be bone marrow dysfunction and the emergence of blood cancers," Patel added.

"This study provides much sought-after explanation of the biology underpinning the devastating childhood disease Fanconi anemia. In future this work may underpin new treatments for this genetic disease, which currently is associated with a very poor prognosis. It also helps to inform large numbers of the global population, who are deficient in the ALDH2 enzyme, that drinking alcohol may be inflicting invisible damage on their DNA," commented Sir Hugh Pelham, director of the MRC Laboratory of Molecular Biology.

Monday, August 27, 2012

Meek Mill Donates $20,000 to Injured Motocross Rider for Stem Cell Therapy in Panama

Meek Mill is putting his money where his mouth is as far as motocross rider Brad Frace is concerned.

The acclaimed recording artist, who is an avid four-wheel and motorcycle trickster, is leading the charge to raise money for another motorcycle enthusiast, Brad Frace. Brad suffered a spinal cord injury during a race in 2011. After the crash, Brad was confined to a wheelchair. However, through hard work and determination, he is now able to stand on his own. Brad still lacks sensation in his feet, and hopes to improve his walking by undergoing stem cell therapy in Panama.

Brad will receive 16 stem cell injections and 19 physical therapy sessions during his stay. He'll be receiving 2 IV and 2 intrathecal injection of his own bone marrow-derived stem cells along with 8 intrathecal expanded and non-expanded umbilical cord-derived stem cells, and 4 IV injections of umbilical cord-derived stem cells.

The procedure Brad's seeking costs about $30,000. Including airfares, food and hotel for the one-month stay, the Frace's estimate the total cost of the trip to be about $40,000. Meek Mill has promised to chip in half of that cash or $20,000. "I was surprised nobody else ain't help him with it," Meek says in his video clip. "When we somebody workin' or whatever they tryin' to do, we help 'em out."

Mill is now appealing to his fans to help Brad raise the other $20,000. To learn more about Brad's story, or to donate, check out Brad's recovery project website:


Thursday, August 16, 2012

Stem Cell Treatment for Multiple Sclerosis in Panama - "After 1 year, I don't need my cane..."

One year after stem cell therapy for multiple sclerosis (MS) at the Stem Cell Institute in Panama City, Panama, Shirley Wigfall shares her success story. Shirley was diagnosed in 2003 after having trouble walking. After MS drugs were unsuccessful and she was rejected for clinical trials, Shirley found the Stem Cell Institute. Shirley no longer needs a cane to walk and credits stem cells for "truly changing her life".

For more information on stem cell treatments for MS: http://www.cellmedicine.com/treatment/multiple-sclerosis/

Friday, August 10, 2012

Mesenchymal Stem Cells Stop Arthritis in its Tracks - Duke University

Researchers at Duke University announced a promising new stem cell therapy aimed at osteoarthritis prevention after a joint injury.

The probability of developing arthritis after injury (post-traumatic arthritis - PTA) greatly increases after injury. Currently, the US FDA has not approved any drugs that slow or eliminate the progression of PTA.

However, at Duke researchers are beginning to confirm mesenchmal stem cell (MSCs) therapy in arthritis treatment. The treatment is similar to that which professional athletes and others have been seeking abroad in places like Panama and Germany for the past few years.

Ref: Pro/Am Dancer is "Dancing with the Stars" Again After Stem Cell Therapy in Panama

In the study, mice sustaining fractures that commonly lead to arthritis were treated with MSCs. "The stem cells were able to prevent post-traumatic arthritis," said Farshid Guilak, Ph.D., director of orthopaedic research at Duke and senior author of the study.

The study was published on August 10 in Cell Transplantation.

Lead author Brian Diekman, Ph.D said the scientists observed markers of inflammation and noted that the stem cells affected the joint's inflammatory environment following injury.

"The stem cells changed the levels of certain immune factors, called cytokines, and altered the bone healing response," stated Diekman.

The Duke team used mesenchymal stem cells isolated from bone marrow. Bone marrow stem cells are very rare; making isolation difficult and requiring that the isolated cells be cultured in the lab under low-oxygen conditions.

"We found that by placing the stem cells into low-oxygen conditions, they would grow more rapidly in culture so that we could deliver enough of them to make a difference therapeutically," Diekman said.

A richer source of mesenchymal cells is adipose (fat) tissue. Therapeutic doses of MSCs are routinely harvested from fat tissue and do not require culturing in the lab. However, it does takes 5 five days to thoroughly test the adipose cell samples for aerobic bacteria, anaerobic bacteria and endotoxins.

Ref: Stem Cell Therapy for Osteoarthritis

Wednesday, August 8, 2012

Jorge Paz MD – Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Diseases (Part 2 of 3) || Video

Stem Cell Institute Spring Seminar 2012
Gilbert, AZ

Stem cell Treatment protocol for autoimmune diseases such as rheumatoid arthritis. Why stem cells must be administered systemically for autoimmune diseases. Dr. Paz elaborates on the disadvantages of same-day fat-derived stem cell treatments. He presents the scientific rationale for treating rheumatoid arthritis (RA) with fat-derived stem cells along with a published case report including patient video. Presentation of similarities between MS and RA and how MS is treated with a combination of human umbilical cord-derived stem cells and adiopose stem cells. Dr. Paz discusses why MS treatment includes umbilical cord-derived stem cells.

Jorge Paz, MD is the Medical Director at the Stem Cell Institute in Panama City, Panama

More information at www.cellmedicine.com

Thursday, August 2, 2012

Jorge Paz, MD - Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Diseases || Part 1 of 3

Stem Cell Institute Spring Seminar 2012
Gilbert, AZ

Dr. Paz discusses his internal medicine background in New York and Texas, and how he got involved with stem cell treatments in Panama. Dr. Paz highlights why licensing, technology and quality control make the Stem Cell Institute in Panama different from other clinics around the world. He touches on why same-day fat-derived stem cell treatments in the US are less than ideal. Dr. Paz concludes part 1 by discussing several US universities with which the Stem Cell Institute has collaborated on research.

Jorge Paz, MD is the Medical Director at the Stem Cell Institute in Panama City, Panama

More information at www.cellmedicine.com

Monday, July 30, 2012

Why does fat (adipose) stem cell therapy take more than one week?

Intravenously administered adipose-derived stem cells will tend to migrate back to the fresh wound site if it is not given an adequate time to heal. Therefore, it is essential to allow about one week after the mini-liposuction before administering any stem cells intravenously. Otherwise, there is a likelihood that the treatment will not be as effective. Additionally, it takes 5 five days to thoroughly test the adipose cell samples for aerobic and anaerobic bacteria as well as endotoxins.

In order to ensure that no patient receives an infected sample, at least 5 days must transpire before the cells can be confirmed safe and injected back into the patient.

Lastly, this 5-day waiting period enables our scientists to culture a small sample of each patient’s stem cells in the lab to observe how they are likely to proliferate once they are inside the body. If a patient’s cells show low viability, Stem Cell Institute doctors will supplement the treatment with additional cord-derived cells to compensate. The same can be done in cases of low cell yield.

Monday, July 23, 2012

Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 5 of 5) || Video

Dr. Riordan discusses current FDA oversight of adult stem cell treatments, "practice of medicine" treatments that are neither regulated nor approved by the FDA, historical examples of successful medical procedures such as bariatric surgery, liposuction and ulcer treatments which were violently opposed by researchers, physicians and companies with competing financial interests.

Treatment information at www.cellmedicine.com/treatment/spinal-cord-injury/

More information on Dr. Riordan at www.neilriordan.net

Thursday, June 14, 2012

Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 4 of 5) || Video

Dr. Riordan presents a video documenting the progress of a T-12 spinal cord injury patient after her combined bone marrow and umbilical cord stem cell treatment in Panama. He also shows video of a 65 year-old man (T-9) who was treated 13 years after his injury. This case illustrates the potential of treating older people whose injuries occurred many years prior to treatment.

Treatment information at www.cellmedicine.com/treatment/spinal-cord-injury/

More information on Dr. Riordan at www.neilriordan.net

Wednesday, June 6, 2012

Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Video

Dr. Riordan continues speaking about mesenchymal stem cell homing to tissue damage, umbilical cord stem cells historically used for anti-aging, mesenchymal stem cells role in immune system modulation, inflammation reduction and stimulating tissue regeneration, donor stem cell safety and testing, the role of HLA matching in donated umbilical cord-derived stem cells, umbilical cord blood safety data and historical use in blood transfusions, and allogeneic stem cell persistence in human mothers.

Treatment information at www.cellmedicine.com/treatment/spinal-cord-injury/

More information on Dr. Riordan at www.neilriordan.net

Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

More progress reported on the treatment of heart disease with endometrial stem cells. Neil Riordan, PhD is one of the early pioneers of endometrial stem cell technology. Dr. Riordan is also the Founder and President of the Stem Cell Institute in Panama City, Panama.

Positive Two-Month Data From RECOVER-ERC Congestive Heart Failure Trial

SAN DIEGO, CA--(Marketwire - Jun 4, 2012) - Medistem Inc. (PINKSHEETS: MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Medistem Contact:

Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive
Suite 450
San Diego
CA 92122
858 349 3617
858 642 0027
twitter: @thomasichim

Tuesday, May 22, 2012

Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Video part 2 of 5)

In part 2, Dr. Riordan discusses case studies of spinal cord injury patients treated with CD34+ and mesenchymal stem cells harvested from human umbilical cord wharton's jelly and cord blood, animal studies using mesenchymal stem cells, immunosuppression requirements in allogeneic stem cell treatments, intrathecal and intravenous administration of autologous bone marrow stem cells in spinal cord injury patients, and the role adult stem cell trophic factors in tissue regeneration.

Monday, May 21, 2012

Multiple Sclerosis Treatment Success Using Mesenchymal Stem Cell-Secreted Factors in Animal Model

Stem cell researchers at Case Western Reserve have reported in Nature Magazine that the functional deficits caused by multiple sclerosis can be reduced by administering mesenchymal stem cell secreted factors.

While previous studies have shown promising results using mesenchymal stem cells, this is the first time that such results have been reported without using the stem cells themselves.

The Stem Cell Institute's Founder, Neil Riordan PhD, originally cited the potential therapeutic role of mesenchymal stem cell trophic factors in the 2010 Cellular Immunology publication: Mesenchymal Stem Cells as Anti-inflammatories: Implications for Treatment of Duchenne Muscular Dystrophy

In addition to reducing functional deficits, the development of new myelinating oligodendrocytes and neurons, release of inflammatory cytokines, and suppression of immune cells influx were also observed in the Case Western study.

Details can be found here:


Hepatocyte growth factor mediates mesenchymal stem cell–induced recovery in multiple sclerosis models

Lianhua Bai, Donald P Lennon, Arnold I Caplan, Anne DeChant, Jordan Hecker, Janet Kranso, Anita Zaremba Robert H Miller

Nature Neuroscience (2012) doi:10.1038/nn.3109
Received 18 January 2012 Accepted 17 April 2012 Published online 20 May 2012


Mesenchymal stem cells (MSCs) have emerged as a potential therapy for a range of neural insults. In animal models of multiple sclerosis, an autoimmune disease that targets oligodendrocytes and myelin, treatment with human MSCs results in functional improvement that reflects both modulation of the immune response and myelin repair. Here we demonstrate that conditioned medium from human MSCs (MSC-CM) reduces functional deficits in mouse MOG35–55-induced experimental autoimmune encephalomyelitis (EAE) and promotes the development of oligodendrocytes and neurons. Functional assays identified hepatocyte growth factor (HGF) and its primary receptor cMet as critical in MSC-stimulated recovery in EAE, neural cell development and remyelination. Active MSC-CM contained HGF, and exogenously supplied HGF promoted recovery in EAE, whereas cMet and antibodies to HGF blocked the functional recovery mediated by HGF and MSC-CM. Systemic treatment with HGF markedly accelerated remyelination in lysolecithin-induced rat dorsal spinal cord lesions and in slice cultures. Together these data strongly implicate HGF in mediating MSC-stimulated functional recovery in animal models of multiple sclerosis.

Friday, May 18, 2012

Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Video part 1 of 5)

Part 1: The Stem Cell Institute's Founder, Dr. Neil Riordan discusses mesenchymal stem cells from umbilical cord Wharton's jelly, stem cell expansion, therapeutic potential of umbilical cord mesenchymal stem cells vs. bone marrow mesenchymal stem cells, CD34+ hematopoietic stem cells from umbilical cord blood and the scientific rationale supporting stem cell treatment of spinal cord injury

Friday, May 11, 2012

Latest Stem Cell Therapy Protocol for Multiple Sclerosis

For the latest information on combination stem cell treatment protocol for MS using the patient's own adipose-derived mesenchymal stem cells and donated human umbilical cord tissue-derived mesenchymal stem cells, please visit:


Wednesday, May 9, 2012

Adult Stem Cells Successfully Treat Spinal Cord Injury

An interesting spinal cord injury study was published last week. The Turkish researchers tested two types of stem cells on spinal cord injured mice. The two cell types were native bone marrow cells and cultured repair stem cells called Mesenchymal stem cells. Native bone marrow cells contain bone marrow forming stem cells as well as a small number of Mesenchymal stem cells.

After injuring the spinal cords, the stem cells were implanted at the site of the injury. The control mice that received no cells had no improvement in neural activity. The mice that received both cell types had improved neural activity. The cultured Mesenchymal stem cell group improved significantly more than the native bone marrow stem cell group.
Stem Cell Rev. 2012 May 3. [Epub ahead of print]

Stem Cell Therapy in Spinal Cord Injury: In Vivo and Postmortem Tracking of Bone Marrow Mononuclear or Mesenchymal Stem Cells.
Ozdemir M, Attar A, Kuzu I, Ayten M, Ozgencil E, Bozkurt M, Dalva K, Uckan D, Kılıc E, Sancak T, Kanpolat Y, Beksac M.

School of Medicine, Department of Neurosurgery, Pamukkale University, 20070, Kinikli, Denizli, Turkey, drmevci@hotmail.com.


The aim of this study was to address the question of whether bone marrow-originated mononuclear cells (MNC) or mesenchymal stem cells (MSC) induce neural regeneration when implanted intraspinally.

The study design included 4 groups of mice: Group 1, non-traumatized control group; Groups 2, 3 and 4 spinal cord traumatized mice with 1 g force Tator clips, which received intralesionally either no cellular implants (Group 2), luciferase (Luc) (+) MNC (Group 3) or MSC (Group 4) obtained from CMV-Luc or beta-actin Luc donor transgenic mice. Following the surgery until decapitation, periodical radioluminescence imaging (RLI) and Basso Mouse Scale (BMS) evaluations was performed to monitor neural activity. Postmortem immunohistochemical techniques were used to analyze the fate of donor type implanted cells.

All mice of Groups 3 and 4 showed various degrees of improvement in the BMS scores, whereas there was no change in Groups 1 and 2. The functional improvement was significantly better in Group 4 compared to Group 3 (18 vs 8, p = 0.002). The immunohistochemical staining demonstrated GFP(+)Luc(+) neuronal/glial cells that were also positive with one or more of these markers: nestin, myelin associated glycoprotein, microtubule associated protein or myelin oligodendrocyte specific protein, which is considered as indicator of donor type neuronal regeneration. Frequency of donor type neuronal cells; Luc + signals and median BMS scores were observed 48-64 % and 68-72 %; 44-80 %; 8 and 18 within Groups III and IV respectively.

MSCs were more effective than MNC in obtaining neuronal recovery. Substantial but incomplete functional improvement was associated with donor type in vivo imaging signals more frequently than the number of neuronal cells expressing donor markers in spinal cord sections in vitro. Our results are in favor of functional recovery arising from both donor MSC and MNCs, contributing to direct neuronal regeneration and additional indirect mechanisms.

Friday, April 27, 2012

Great Day in Ft. Worth for Stem Cell Team

Saturday, March 31 was the annual MS Walk in Ft Worth. This year, thanks to the Stem Cell Institute and some of the area stem cell patients, several of us MS sufferers and stem cell patients met for the Walk. Here’s a picture of several of us who have been to Panama, or Costa Rica, for treatments – (from L – R) Richard, Carolyn, Shelley, Carla, Judi, Holly, and me. We wanted to give the Stem Cell Institute a presence in that sea of MS victims and caregivers. I wish all of them knew that many of us in those blue t-shirts were there walking, actually completing the whole mile, even though we were once unable to do such. I wanted to grab that microphone that the organizers were using and tell all of them “There is HOPE – it doesn’t have to be what you hear from your doctors so often. It can be more than ‘Let’s keep taking this medication so you might get worse at a slower rate’ ” I personally never heard about the possibility of actually improving when I went to good doctors here in the US – but I chose to try the Stem Cell treatment in Panama, and I walked that mile on Saturday! A year ago, six months ago, I couldn’t have done that – but after my third trip to Panama in September, my walking, my balance, and my stamina all improved dramatically. And many of those in our group on Saturday have a similar story; some results more dramatic than others, but most all of us have seen and felt the changes that give us that Hope that all of those sufferers at the Walk are looking for. THANKS STEM CELL INSTITUTE! Sam Harrell Sam in Panama

Thursday, April 19, 2012

Legendary Texas Football Coach and Stem Cell Recipient Sam Harrell Returns to Coaching

In 2010, the debilitating effects of multiple sclerosis forced Sam Harrell to retire from his position as Head Football Coach at Ennis High School. But after receiving 3 courses of stem cell therapy at the Stem Cell Institute in Panama, Sam is returning to the gridiron once again.

Brownwood Lion Head Coach, Bob Shipley announced that Harrell will be joining the team as quarterback coach. Sam coached all three of his sons at Ennis High School, most notably his son Graham Harrell. Graham was a standout quarterback at Texas Tech and now plays for the Green Bay Packers.

During his career at Ennis, Harrell pioneered the spread offense that led the team to three Texas state championships.

"I told the kids this morning," said Coach Shipley when asked about how he addressed the team, "And I didn't have to explain who Sam Harrell was, they knew. And they just erupted in applause and they were just looking at each other with their jaws dropped open, like they couldn't believe that Coach Harrell was going to come and be apart of our staff."

"Sam just really liked the thought of coming and not being the head coach and not being the offensive coordinator, but just coaching the quarterbacks, which is really what his passion is."

The Stem Cell Institute was founded in 2005 by Neil Riordan PhD and has treated over 1,500 patients to-date. Find out more about stem cell therapy for MS at www.cellmedicine.com

Wednesday, April 18, 2012

Quality time: Former Ennis coach Sam Harrell is counting his blessings despite having multiple sclerosis

ENNIS, TX -- Sam Harrell's three state football championships are celebrated in his home office. He has pictures, trophies and balls, and even more memories. For 32 years, Harrell worked in a profession where success is measured by a scoreboard in front of thousands. These days, life's little victories -- unaccompanied by cheers or Gatorade showers -- are just as satisfying. Harrell can jump up and down in his living room. He can walk across a parking lot without a cane or a walker. He can spend hours at Kolache Depot Bakery without getting fatigued. Harrell hasn't beaten multiple sclerosis, but he is successfully living with it. "It puts everything in perspective," Harrell said. "Now, I'd rather play catch with my grandson in the back yard than win a state championship. When that gets taken away from you, you realize how precious it is."

Harrell was 153-51 in 16 seasons at Ennis, winning Class 4A state titles in 2000, '01 and '04. He coached all three of his sons -- Graham, now a backup quarterback with the Green Bay Packers; Zac, the offensive coordinator at Van High School; and Clark, who finished his college career at Abilene Christian in 2010 and now works as a financial planner.

It was in 2005, while he was on the tennis court, that Harrell's vision in one eye became blurry. An eye specialist sent him to a neurologist, who, after running tests, gave Harrell the best possible diagnosis: He had MS. "I didn't know whether I was supposed to cheer or cry," Harrell said. "I got the best of the three things it could be, but the bad news is: I have MS." Multiple sclerosis is a chronic, unpredictable disease that affects the central nervous system. The immune system eats away the myelin sheath surrounding the nerves. Symptoms vary from person to person. Mild symptoms include numbness in the limbs, weakness, fatigue and blurred vision. Severe symptoms include paralysis and loss of vision. There is no known cure for MS.

Harrell chose to keep the news a secret from everyone except his wife, Kathy. He didn't reveal the diagnosis for four years, though, as his condition worsened, those close to Harrell knew something was wrong. "We'd go to practice, and he had to take a golf cart," Graham Harrell said in a phone interview after a recent Packers practice. "Sometimes he was off balance a little bit, or shaky walking. So there were times we knew something wasn't quite right, but we didn't know exactly what was going on until he finally told us. "It was hard to watch, obviously, especially with him wanting to coach, and yet not being able to do it like he used to. But recently, he's seen great improvement, and that's huge encouragement not only to him, but to us, and hopefully he'll continue to get better."

Sam Harrell knew his MS wouldn't kill him, but he thought not coaching might. Sam's father, Jake, established the family business at Seminole, where he spent 20 seasons, including 10 as the head coach. But Sam Harrell's health forced him to quit coaching before the 2010 season. "That's all I'd done my whole life," Harrell said, "so I was sick about it. I just didn't know what I was going to do. "I do wish I could still do it, but I haven't died from not coaching."

Harrell, in fact, is alive and well. He credits three trips to Panama for his improved health. After he retired from coaching, Harrell began researching regenerative medicine. Stem cell treatment is not approved in the United States, but Dr. Neil Riordan, who lives in Trophy Club, is the founder of the Stem Cell Institute in Panama. Riordan is one of the leading stem cell scientists in the world. Harrell talked to several of Riordan's patients, including Richard Humphries, a golf coach out of Diamond Oaks Country Club in Fort Worth. Humphries was diagnosed with MS in 2005.

He began stem cell treatments in 2008. Stem cell treatments introduce new cells, which have regenerative potential, into damaged tissue to treat disease or injury. "After talking to Richard, I didn't have the money, but I knew I was going to go," Harrell said. "I mean, what did I have to lose? I knew where I was headed if I didn't go. I was going downhill fast. So why wouldn't I go try this?" Friends, family and fellow coaches held fundraisers for Harrell's treatments. Harrell's first trip to Panama, which was four weeks, cost $40,000. He has been back twice more, the last time in September.

It wasn't until the third visit that Harrell saw dramatic results. "MS is like a two-hump camel," Humphries said. "You can get over the first hump of active T-Cells fairly easily, but the second hump, the memory T-Cells, sometimes bring our MS symptoms back, as it did with Sam. "He was extremely disappointed for taking the two steps back after three steps forward. I told him it may take another two or three treatments to really get you going again. Needless to say, he could not stop smiling and was greatly relieved. Now, he is seeing the results." Harrell is a strong Christian and is quick to credit God and prayer for his recovery. But he also is a big believer in stem cell therapy.

Kathy Harrell is a more recent convert. She was skeptical until seeing the change in Harrell. "I just feel really grateful that these are good days and good months, and I'm not going to worry about next year," Kathy Harrell said. "It just makes you thankful that things are good right now, and he's pretty mobile. This disease reminds you to just be thankful for the day, so that's what we're doing. I realize now it can be worse." Charean Williams

Monday, April 16, 2012

Spinal cord injury patient discusses his gains following stem cell therapy at the Stem Cell Institute in Panama

Spinal cord injury patient, Chris Niles, discusses his improvements after undergoing stem cell therapy at the the Stem Cell Institute in Panama City, Panama. Chris now has sensation down to about a T10 level and has regained movement in his feet.

New Stem Cell Therapy Guidelines Approved in Texas

The Texas Medical Board has approved new rules regulating adult stem cell therapies similar to the ones used to treat Governor Rick Perry last summer, the Associated Press (AP) reported on Friday.

The rules were drafted by the state board, which licenses and disciplines doctors, at the request of Houston’s Dr. Stanley Jones, the same man who in July 2011 injected Perry with the governor’s own stem cells in order to help him recover from a back injury, Nathan Koppel of the Wall Street Journal said.

Koppel noted that the new regulations will make it easier for medical professionals in Texas to offer the experimental treatments without needing to obtain federal approval, while the AP added that the rules to require patients to provide their express consent to the procedure, as well as receive approval from a review board before the stem cell therapy is permitted to begin.

“We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection,” Texas Medical Board President Dr. Irwin Zeitler told Todd Ackerman of the Houston Chronicle. “The wheels of federal government move so slowly – we’re not willing to wait to protect our patients.”

The rules were approved by a 10-4 vote, and members of the board have promised that they will consider revising and improving the policy as early as June, when they meet again, Ackerman said. The official start date for the new policy was not announced, but staffers told the Chronicle that it will be at least 30 days.

While Perry has lauded the stem cell treatment he has received, not everyone shares his enthusiasm for the procedure, according to Minjae Park of the New York Times.

Some researchers argue that the evidence of stem cell injections is anecdotal in nature, and that the results of clinical trials should ideally be obtained before doctors are allowed to perform the treatment, which can cost tens of thousands of dollars, added Park.

Leigh Turner, a professor at the University of Minnesota’s Center for Bioethics, told the New York Times, that there were “some real problems” with the Texas regulations, adding that the “protective mechanism that they’re focusing on” would not be able to do terribly much.

Mario Salinas, the director of Texans for Stem Cell Research, countered that the rules would protect patients and help eliminate treatments without some kind of oversight. As he told Park, “Doing something at this point is better than doing nothing… This is just the first step.”

Monday, April 2, 2012

"The fight to walk" - spinal cord injury patient improving after stem cell therapy in Panama

Published March 31, 2012
By Sue Guinn Legg - Press Staff Writer

Daniel Leonard is doing all he can to walk again, and after a recent course of stem cell treatment he’s as close as he has been since a few months after the 2005 injury that put him a wheelchair.

He was 22 years old and about to begin his third year of college when he woke up one August morning on the floor at his family’s Johnson City home unable to move and struggling to breathe.

While the cause of his injury remains a mystery, what is known is that three vertebrae near the top of his spine had been crushed, leaving him paralyzed from the neck down, on a ventilator and not expected to never walk or even breathe on his own again.

Six months after undergoing surgery to remove the bone fragments from his spinal cord, Leonard, who had played several sports in high school and was boxing at the Johnson City Athletic club prior to his injury, was exceeding all expectations.

In treatment at the Patricia Neal Rehabilitation Center in Knoxville, he was not only breathing independently, he was pulling himself up on parallel bars and being fitted with leg braces to help him take his first steps.

Then the unthinkable happed, again. Because there had been nothing done to stabilize his damaged vertebrae, his spine collapsed at the site of his injury and all of his progress was lost.

“I worked my butt off to get to the point I was about to start walking,” he said. But the gains he had made in upper body strength were erased and there was no longer any movement in his legs.

After a second surgery to fuse the bones, his condition was labeled as “incomplete paraplegia” characterized by limited movement and sensation in all the muscles below his neck and none at all in his legs. Doctors told his family he would never be able to move his legs, and for many years he could not.

For a while, he lived independently with the assistance of a caregiver. When his caregiver left, he moved to a nursing home, expecting to stay only long enough to find another place and another caregiver. But without money to finance that plan, months turned into years and the Four Oaks Health Care Center in Jonesborough became his home for the long term.

Early last year, things took a turn for the better when for reasons unknown he began to regain some movement in his legs. Encouraged, Leonard once again threw all his effort into physical therapy. In October, he began working out regularly with Amy Caperton, a personal trainer at the Tri-Cities Lifestyles fitness center in Johnson City, and coupled that with physical therapy at the new Mountain States Rehabilitation Center.

His family, who had long believed stem cell treatment would provide his best chance at recovery, stepped up their efforts to pay for the treatment.

His sister, Rachael Leonard, a business consultant who had been following the progress of stem cell research and exploring treatment options since a few days after Daniel was injured, zeroed in on The Stem Cell Institute, a reputable facility in Panama founded by Neil Riordan PhD, that concentrates on treatment of spinal cord injuries, muscular sclerosis, rheumatoid arthritis and heart disease.

His mother and siblings pooled their resources and came up with about half the $45,000 needed for the $35,000 cost of his first four-week course of treatment and travel expenses for Daniel, Rachel and their mother, Diane, to make the trip to Panama.

The balance was raised through a series of small benefits — dinners at area restaurants, a concert and an auction, and through many individual gifts and online contributions to Daniel’s fundraising page, www.givefoward.com/danielleonardstemcells.

“People we know around here and businesses were very generous and there was a lot of money raised,” his mother said.

To clear up any misconceptions about the treatment, the family emphasized to everyone interested that the stem cells used at the institute come from umbilical cords donated by new parents and the patients’ own bone marrow and referred them to www.cellmedicine.com for specifics.

“I’m not trying to tell people what to do with their own bodies, but for me, if it had been kill a baby to walk again, there’s no way I would have,” Daniel Leonard said.

The family finally made it to Panama in February. The treatment began with two weeks of daily cord blood cell injections into his spinal fluid and two hours of “intense interval” therapy that requires Leonard to work his muscles as hard as possible for one minute, rest for two minutes and repeat the process over the course of an hour.

“One hour is what they do, but with what I had been doing with Amy already, I thought I needed more,” he said.

The injections were painful and the workouts exhausting, so Leonard was relieved when Panama’s annual carnival week celebration gave him a week of rest before the treatment resumed with another two weeks of daily injections of cells drawn from his hip bones.

On the second day of his fourth week of treatment, Leonard experienced his first noticeable improvement when he flexed the right calf muscle he had not been able to move in years. The following day he felt himself contracting the pectoral muscles in his chest.

Day by day he’s regaining strength and there have been many small, but encouraging, gains that have also been obvious to caregivers. At Four Oaks, his aides are changing the way they handle things. While transferring Leonard from bed to a chair, it’s easier for them to raise him to his feet to pivot, which can now be done with one person’s assistance rather than two.

“These are all little things, but they are huge for us,” Leonard said.

Caperton, who with help from a client at Lifestyles spent a few days in Panama learning all she could from doctors and therapists at the institute, is equally encouraged.

“I am trying to be objective, but I must say he is making drastic improvements and it excites me,” she said.

The next six months before the stem cells die hold Leonard’s greatest opportunity for improvement, and continuing his physical training will play a critical role in the treatment’s effectiveness.

Optimum recovery will come with repeat treatments, and the fundraising for Leonard’s next trip to Panama is under way. There’s a three-on-three basketball tourney being planned at the Lifestyles center, and Leonard is searching for a local business to put up a prize worthy of the tournament’s entry fee.

He’s inviting everyone to follow his progress at his Facebook page, Daniel Leonard Search for a Cure (http://on.fb.me/H6sAtf). And for anyone who wishes to help, online donations may be made at www.giveforward.com/daniellenoardstemcells.

Donations to the “Daniel Leonard Search for a Cure Fund” can also be made at any First Tennessee Bank location or by mail to First Tennessee Bank, 1500 W. State of Franklin Road, Johnson City, TN 37604.

“Hopefully, with the next treatment I’ll be able to stand,” he said. “I’m excited about it. I can’t wait to see the results.”

Monday, March 12, 2012

Medistem Signs Exclusive Worldwide License With Yale University for Treatment of Type 1 Diabetes Using Stem Cells

Acquisition of Intellectual Property and Data Leads to Expansion of Medistem Therapeutic Pipeline

SAN DIEGO, CA, Mar 07, 2012 (MARKETWIRE via COMTEX) — Medistem Inc. (pinksheets:MEDS) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.

Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.

“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”

Medistem is currently in two clinical trials with ERCs: One for critical limb ischemia and a second for congestive heart failure, both of which are complications of uncontrolled diabetes.

“Type 1 diabetes is a rapidly growing poorly-served market. There is great optimism that cell-based therapies can address not only pancreatic degeneration but also the underlying immunological causes,” said Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, the largest non-profit organization focused on development of new therapeutic approaches for this disease. “The ERC is the newest adult stem cell to enter clinical trials. Based on this unique source of cells, as well as their immune modulatory properties, we believe this work may be expanded into other autoimmune diseases.”

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company’s lead product, the endometrial regenerative cell (ERC), is a “universal donor” stem cell being developed for critical limb ischemia and congestive heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem’s collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Wednesday, March 7, 2012

Medistem Inc. to Add Kidney and Lung Failure to Clinical Trials of Endometrial Regenerative Cells (ERC) Stem Cells in Russia

SAN DIEGO, CA and PORTLAND, OR, Mar 05, 2012 (MARKETWIRE via COMTEX) -- Medistem Inc. (pinksheets:MEDS), in partnership with its Russian licensee, ERCell, announced the signing of a letter of intent* to begin clinical trials using Medistem's Endometrial Regenerative Cells (ERC) stem cells for renal, lung and peripheral artery disease. Trials will be conducted in the S.M. Kirov Military Medical Academy in St. Petersburg, Russia. Under the agreement, Medistem, ERCell and the Academy will work together to a) Design and obtain approval for clinical trials; b) Provide training and execute the trials; and c) Identify opportunities for commercialization of the ERC product through existing military and governmental programs.

Under the license agreement, Medistem receives cash and royalty revenues from Russian developmental activities as well as all the data gathered from the trials. According to the agreement, work performed by ERCell will be conducted according to international "Good Clinical Practices" (GCP) so the data gathered can be used for Russian registration as well as to support US FDA submissions.

"At Medistem, our philosophy has always been to follow the data. We aim to be as aggressive as possible, to obtain as much data as possible, as quickly as possible," stated Thomas Ichim, CEO of Medistem. "We are especially optimistic about the possibility of obtaining human data in renal failure patients, something that we otherwise would not have pursued at this stage if it weren't for the support of the S.M. Kirov Military Medical Academy."

"As the Medistem licensee for Russia and CIS (Commonwealth of Independent States), ERCell is committed to advancing our programs using as many non-dilutive means as possible," said Tereza Ustimova, CEO of ERCell. "By partnering with the best institutes in the country, we are committed to making ERCell Russia's premiere universal donor adult stem cell company."

S.M. Kirov Military Medical Academy conducts research in the following areas: metabolic derangements of cardiovascular pathology, nanotechnologies in biology and medicine, stem cells as a basis for the treatment of internal organs and blood diseases, blood circulation, vegetative nervous system and high-tech methods of diagnosis and treatment.

"We are highly impressed by the fact that the Endometrial Regenerative Cell (ERC) is the newest stem cell product to enter clinical trials. By the higher growth factor production ability compared to other types of stem cells, we are very eager to begin clinical trials," said Oleg Nagobovich, M.D., Chief of the Research Center, S.M. Kirov Medical Military Academy. "We feel our work will complement the ongoing work at the Backulev Center addressing heart failure by Medistem/ERCell."

*Letter of intent issued by Ministry of Defense, dated 2/24/12, No. 411A/119

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive, Suite 450
San Diego, CA 92122
858 349 3617
858 642 0027

www.medisteminc.com twitter: @thomasichim

SOURCE: Medistem Inc.