Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

Dallas, TX (PRWEB) April 03, 2014

Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells (UC-MSC) for multiple sclerosis from the Comité Nacional de Bioética de la Investigación (CNEI) Institutional Review Board (IRB) in Panama.

According to the US National Multiple Sclerosis Society, in Multiple Sclerosis (MS), an abnormal immune-mediated T cell response attacks the myelin coating around nerve fibers in the central nervous system, as well as the nerve fibers themselves. This causes nerve impulses to slow or even halt, thus producing symptoms of MS that include fatigue; bladder and bowel problems; vision problems; and difficulty walking. The Cleveland Clinic reports that MS affects more than 350,000 people in the United States and 2.5 million worldwide.

Mesenchymal stem cells harvested from donated human umbilical cords after normal, healthy births possess anti-inflammatory and immune modulatory properties that may relieve MS symptoms. Because these cells are immune privileged, the recipient’s immune system does not reject them. These properties make UC-MSC interesting candidates for the treatment of multiple sclerosis and other autoimmune disorders.

Each patient will receive seven intravenous injections of UC-MSC over the course of 10 days. They will be assessed at 3 months and 12 months primarily for safety and secondarily for indications of efficacy.

The stem cell technology being utilized in this trial was developed by Neil Riordan, PhD, founder of Medistem Panama. The stem cells will be harvested and processed at Medistem Panama’s 8000 sq. ft. ISO-9001 certified laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.

From his research laboratory in Dallas, Texas, Dr. Riordan commented, “Umbilical cord tissue provides an abundant, non-controversial supply of immune modulating mesenchymal stem cells. Preclinical and clinical research has demonstrated the anti-inflammatory and immune modulating effects of these cells. We look forward to the safety and efficacy data that will be generated by this clinical trial; the first in the western hemisphere testing the effects of umbilical cord mesenchymal stem cells on patients with multiple sclerosis.”

The Principle Investigator is Jorge Paz-Rodriguez, MD. Dr. Paz-Rodriguez also serves as the Medical Director at the Stem Cell Institute.

For detailed information about this clinical trial visit http://www.clinicaltrials.gov . If you are a multiple sclerosis patient between the ages of 18 and 55, you may qualify for this trial. Please email trials (at) translationalbiosciences (dot) com for more information about how to apply.

About Translational Biosciences

A subsidiary of Medistem Panama Inc., Translational Biosciences was founded solely to conduct clinical trials using adult stem cells and adult stem cell-derived products.

Translational Biosciences Web Site: http://www.translationalbiosciences.com
Email: trials@translationalbiosciences.com

About Medistem Panama Inc.

Since opening its doors in 2007, Medistem Panama Inc. has developed adult stem cell-based products from human umbilical cord tissue and blood, adipose (fat) tissue and bone marrow. Medistem operates an 8000 sq. ft. ISO 9001-certified laboratory in the prestigious City of Knowledge. The laboratory is fully licensed by the Panamanian Ministry of Health and features 3 class 10000 clean rooms, class 100 laminar flow hoods, and class 100 incubators.

Medistem Panama Inc.
Ciudad del Saber, Edif. 221 / Clayton
Panama, Rep. of Panama

Phone: +507 306-2601
Fax: +507 306-2601

About Stem Cell Institute Panama

Founded in 2007 on the principles of providing unbiased, scientifically sound treatment options; the Stem Cell Institute has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, our comprehensive stem cell treatment protocols employ well-targeted combinations of autologous bone marrow stem cells, autologous adipose stem cells, and donor human umbilical cord stem cells to treat: multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, and autoimmune diseases. To-date, the Institute has treated over 2000 patients.

For more information on stem cell therapy:
Stem Cell Institute Website: http://www.cellmedicine.com

Stem Cell Institute
Via Israel & Calle 66
Plaza Pacific Office #2A
Panama City, Panama

Stem cell treatments for spinal cord injury - Jamie Richie discusses her improvements

Jamie Richie discussed her treatments and improvements while undergoing her third round of stem cell therapy at the Stem Cell Institute in Panama City, Panama.

Jamie’s first round of treatment comprised 8 intrathecal (into the spinal fluid) infusions of human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC); 4 intravenous infusions of hUC-MSC; 2 intrathecal infusions of autologous (their own) bone marrow mononuclear cells (BMMC); 2 intravenous injections of BMMC and 19 physical therapy sessions over the course of one month. Her second round of treatments comprised half the infusions of the first.

My name is Jamie Richie. This is my third treatment here. I was diagnosed with a L-1 injury. That was back in January 1st, 2010.

What symptoms did you have before you came for treatment?

I had no movement from my L-1 level down. As far as my right leg, I couldn’t stand on it at all without a brace. If I had a brace on it I could stand and I could walk and all, with braces; and a more aggressive brace. My pain was very strong. My legs; the circulation was worse in my legs. Their color, they were very purple. I could not walk on a treadmill. I had a hard time walking on uneven ground.

What kind of improvements have you experienced since your first treatment?

I’ve improved. I’ve had like five major things after my very first treatment, which was a year ago in January. I was able to stand on my right leg without a brace and walk. My pain level dropped between a 10 down to a 6. It’s controllable. The circulation in my legs; my balance is better. I can carry things while walking with a walker. I can transfer something from one counter to the next. I can be in my kitchen, hold onto the counter and stand and get out a glass out of the cabinets. I can walk on a treadmill and I am actually able to walk three speeds higher than when I first started walking. So I’ve had great gains there. After my second treatment, I was able to walk even stronger on my right leg. I have better bladder control. I got better bladder control out of the first treatment. And I noticed that I didn’t get a whole lot until about two months after the treatment.

How has this experience changed your life?

This experience has changed my life, just one, the nerve pain. I’m more comfortable driving. I can walk barefoot on my right leg without any braces or… It’s just nice being able to walk barefoot. Being able to get onto the treadmill, that’s huge for me. I don’t have to drive to a park or a track and walk on a track. I can get on the treadmill and keep a good pace and keep better tracking of what my progress is. For my balance, being able to stand and take my clothes out of my washing machine and put them in my dryer to standing in the kitchen and being able to take a pan that has water in it and put it in the sink. I was unable to do any of that. If I were standing, would have to have help. Transferring, you know, something from one counter to the next. Walking on uneven ground is big for a life change. If someone comes to the house to pick me up, walking to the car. To be able to walk into a store, I can go to the grocery store, walk in, get into a power chair and do all my grocery shopping there. So, get back onto the walker and get back into my car. It’s given me more independence, which is very big for me.

What would you say to someone who is considering this treatment?

It’s not going to hurt you to try it. It’s going to hurt you not to try it. If I could suggest anything, I would just say as soon as you’re better from your injury where you are not in any more pain and able to get to therapy, I would go. And I would go as soon as you can. Otherwise, you’re going to sit back and go, “Gee what if I wouldn’t of? What if I had gotten?“ There are a lot of people to talk to. There are people who didn’t gain anything. I have not spoken to anybody who didn’t gain anything off a spinal cord injury. Do your homework. It’s worth it and it doesn’t hurt. I mean, it doesn’t hurt me. I can feel completely my whole back. So when I get the injections in my spine… The anesthesiologist is excellent. The doctor is excellent. I will have close to 20 injections in my back and I have had no bad experiences at all. I’ve had no negative side effects at all, none. I’ve only had positive side effects.

Neil Riordan PhD on stem cell expansion in stem cell therapy

Stem Cell Pioneers featured Dr. Riordan in its February installment of "Ask the Doctor", a monthly segment that features stem cell scientists and doctors answering questions from readers about stem cell therapy.

Over the next several days, we will share these questions and Dr. Riordan's answers with our readers.

Question: Are there some conditions such as neurological ones that respond better when the cells are greatly expanded? Is a high quantity essential for success or is that something that may be more of a selling point at some clinics? I have also seen this advertised for COPD and other conditions. It's almost like the more cells the better, but I would like your opinion.

Dr. Riordan's Answer: That really depends on the quality of the cells after expansion. If they are still robust, not senescent, and still have a good secretion profile, then the more the better may be useful up to a point. If you take a small pool of starter cells and expand them to exhaustion, then I don’t think you are going to have a very good product. The MSCs used in Panama are not expanded beyond passage 5—a point at which there is no senescence in the population and they have a robust cytokine secretion profile. In order to use only cells that meet our release criteria, cells from approximately one (1.2 to be exact) out of 10 donated umbilical cords are used.

Contrast that to cells from a patient’s own fat tissue that are expanded. Firstly, the starting cells may, and many times are not very robust—they secrete little or no beneficial cytokines or chemokines, and must be expanded to hilt in order to hit the cell number. Please see my answer to number 7 for more on this subject.

This brings up a slightly different, yet related topic. There has been a lot of talk at recent meetings about more defined endpoints for the cells being used, and I couldn’t agree more. There are MSCs from bone marrow, menstrual blood, fat tissue, umbilical cord (even different parts of the umbilical cord—around the blood vessels, from the Wharton’s jelly, from the subepithelium, from the cord blood itself—which are most likely contaminants from a bruised placenta rather than the blood), teeth, amniotic membrane, amniotic fluid just to name sources in the “we didn’t mess with mother nature” adult stem cell world. Add to that the infinite variables when you consider the age and physical condition of the donor, particularly when using adipose or bone marrow as a source material and we, as a field, could be saying almost anything by using the term, “mesenchymal stem cell.” I think it is time that there is standardization in the field beyond the current definition of expressing/not expressing certain surface markers and the ability to differentiate into fat, bone, and cartilage. That standardization could come from using endpoints such as “remaining proliferative capacity (the number of doublings achievable in culture from the treatment cell bank), the secretome, even if there is standardization of one or two molecules, such as HGF, or one of the prostaglandins.

In the future I believe the field will take it a step further by measuring, even by a surrogate marker, the potential effects of the cells on the target condition. In the case of autoimmunity the cells and their secretions could be tested for their capacity to modulate the immune system. In the case of inflammatory conditions, the cells and their secretions could be tested for the ability to control or block inflammation.

Neil Riordan PhD on Peri-lymphatic Stem Cell Treatment for Multiple Sclerosis

Stem Cell Pioneers featured Dr. Riordan in its February installment of "Ask the Doctor", a monthly segment that features stem cell scientists and doctors answering questions from readers about stem cell therapy.

Over the next several days, we will share these questions and Dr. Riordan's answers with our readers.

Question for Dr. Riordan: I have heard from patients that you are doing intralymphatic stem cell injections. I think there are a lot of IntraLymph studies on other things like allergies, but none on stem cells that I can find. What is the reasoning behind this new route of administration? If stem cells get stuck in the lungs and we worry about that, why inject them directly into the lymph system where they would go to the spleen?

Dr. Riordan's Answer: The goal of our treatments umbilical cord mesenchymal stem cells for patients with multiple sclerosis really has nothing to do with repairing the damaged or destroyed myelin in the lesions found in the brain and spinal cord. Because multiple sclerosis is first and foremost an autoimmune disease our goal is to address the immune dysfunction. At the root of the disease is a pool of immune cells called T-cells, which actively proliferate, cross the blood brain barrier, and attack myelin. Our primary goal then is to interfere with myelin-specific T-cell reproduction (something called “clonal expansion’). Mesenchymal stem cells (MSCs) have been shown in multiple studies to have the capacity to block this so-called clonal expansion of activated T cells. In a way MSCs immunosuppress, but unlike some drugs that suppress the immune system this specific blocking of activated T cells does not quash the entire immune system—the cells and their secretions only block the clonal expansion. Other drugs that suppress the immune system—for example hydrocortisone—have an effect on the entire immune system, which can increase the risk of the recipient to infectious diseases and even some cancers.

If it were the goal of the treatment to induce remyelination then certainly the route of delivery would be of greatest importance. You would want for the cells (or whatever proposed remyelination agent) to be as close to the lesions requiring the repair as possible. So I understand the rationale for the question.

In my opinion it will be difficult to successfully treat multiple sclerosis by remyelination alone because if you do not address the immune problem you will continue to lose myelin. Therefore, getting the cells to the lesions for myelin repair is not particularly important. Further support for this opinion is that there is very good evidence that the body has the innate ability to regenerate myelin without intervention. There are two good examples of this. The first example comes from a condition called Guillain–Barré syndrome. The syndrome is an autoimmune disease that results from an immune attack on the myelin of peripheral nerves. There is an ascending paralysis and the condition can be life threatening if the paralysis gets high enough to affect breathing. It is treatable and generally temporary. In 80% of the patients the underlying nerves are not irreparably damaged and there will be no long-term neurologic symptoms. 20% experience permanent nerve damage because the axons of the nerves are damaged. The good news is that the disease is temporary. The better news is that in the mild cases in which the axons were not destroyed, complete remyelination occurs—the body has the capacity to restore myelin.

The second example comes from a phenomenon seen with serial MRI images of the brains in people with MS. Fifty percent of these low intensity lesions known as “black holes” revert within one month of appearance, indicating that remyelination has occurred spontaneously.

Further support for the “treat the immune system and not the Central Nervous System” in MS comes from the work of several groups, including Northwestern University who are using chemotherapeutic “conditioning”, ie. wiping out the immune system (and the by-standing hematopoietic stem cells) followed by bone marrow reconstitution using previously harvested bone marrow stem cells. There are published results of many cases improving without anything having been done to address the myelin loss.
To the question of intra-lymphatic injections: There has been no work on “intra-lymphatic” injections. We are looking into peri-lymphatic (near the lymph nodes) injections of huMSCs for patients who are refractory to intravenous treatment.
Here is a little background on this subject: Dr. Arnold Caplan of Case Western Reserve, the scientist to first describe mesenchymal stem cells, was in Panama last year consulting with us. He also presented at a conference that we cosponsored. In one of my discussions with Dr. Caplan he casually mentioned that whenever they injected mesenchymal stem cells into the abdominal cavity of animals that did not have an active inflammatory process in there in the cavity the MSC’s would automatically go to the abdominal lymph chains. They were able to determine this because they use cells that were labeled with the florescent probe. I found this very interesting given that the 70-80% of the immune cells of your body reside in the abdominal cavity in and around the intestines.

The rationale for peri-lymphatic treatment is relatively simple. Firstly, the goal of therapy in autoimmune disease is to induce immune tolerance in the face of immune intolerance. The majority of the immune cells are found in the lymphatic (which includes the lamina propria) system of the gut. MCSs will, when lacking a more compelling inflammatory signal, migrate to the lymph nodes. Once in the lymph nodes they will migrate and interact with the immune cells (T-cells and T-cell priming dendritic cells). We know for a fact that MSCs interfere with dendritic cell priming of T-cells.

My book will be coming out in April. It will go into greater detail on this subject and many more. There are case histories as well as treatment protocols and rationale for each condition. Information about how to get the book “Mesenchymal Stem Cells: Nature’s Pharmacy” will be on www.Riordanbooks.com, as well as on www.amazon.com.

Panama’s First Umbilical Cord Stem Cell Clinical Trial for Rheumatoid Arthritis Approved by Comité Nacional de Bioética de la Investigación Institutional Review Board

Panama City, Panama (PRWEB) January 14, 2014

Translational Biosciences, a subsidiary of Medistem Panama has received the county’s first clinical trial approval for the treatment of rheumatoid arthritis with human umbilical cord-derived mesenchymal stem cells (MSC) from the Comité Nacional de Bioética de la Investigación Institutional Review Board (IRB).

Rheumatoid Arthritis (RA) is an autoimmune disease in which the patient’s immune system generates cellular and antibody responses to various components of the joint such as type I collagen. As a result of this immune response, not only does joint destruction occur, but also other secondary complications such as pulmonary fibrosis, renal damage, and even heart damage. RA affects approximately 0.5-1% of the population in the United States.

Mesenchymal stem cells harvested from donated human umbilical cords after normal, healthy births possess anti-inflammatory and immune modulatory properties that may relieve RA symptoms. Because they are immune privileged, the recipient’s immune system does not reject them. These properties make MSC interesting candidates for the treatment of rheumatoid arthritis and other autoimmune disorders.

Each patient will receive five intravenous injections of umbilical cord stem cells over the course of 5 days. They will be assessed at 3 months and 12 month primarily for safety and secondarily for indications of efficacy.

The stem cell technology being utilized in this trial was developed by Neil Riordan, PhD, founder of Medistem Panama. The stem cells will be harvested and processed at Medistem Panama’s 8000 sq. ft. laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.

The Principle Investigator is Jorge Paz-Rodriguez, MD. Dr. Paz-Rodriguez also serves as the Medical Director at the Stem Cell Institute.

“While this is just the first step, it is our hope that Panama’s rapid emergence as a leader in applied stem cell research will lead to safe, effective treatments for debilitating diseases such as rheumatoid arthritis and serve to benefit all Panamanians who suffer from it in the not-too-distant future,” said Ruben Berocal, M.D., National Secretary of Science, Technology and Innovation (SENACYT). “Oversight by the National Committee for Investigational Bioethics ensures patient safety by demanding ethical transparency and compliance with the highest levels of international standards,” he added.

For detailed information about this clinical trial visit http://www.clinicaltrials.gov. If you are a rheumatoid arthritis patient who has not responded to disease modifying anti-rheumatic drugs (DMARD) for at least 6 months you may qualify for this trial. Please email trials@translationalbiosciences.com for more information about how to apply.

About Translational Biosciences

A subsidiary of Medistem Panama Inc., Translational Biosciences was founded solely to conduct clinical trials using adult stem cells and adult stem cell-derived products.

Translational Biosciences Web Site: http://www.translationalbiosciences.com

Email: trials@translationalbiosciences.com

About Medistem Panama Inc.

Since opening its doors in 2007, Medistem Panama Inc. has developed adult stem cell-based products from human umbilical cord tissue and blood, adipose (fat) tissue and bone marrow. Medistem operates an 8000 sq. ft. ISO 9001-certified laboratory in the prestigious City of Knowledge. The laboratory is fully licensed by the Panamanian Ministry of Health and features 3 class 10000 clean rooms, class 100 laminar flow hoods, and class 100 incubators.

Medistem Panama Inc.
Ciudad del Saber, Edif. 221 / Clayton
Panama, Rep. of Panama

Phone: +507 306-2601
Fax: +507 306-2601

About Stem Cell Institute Panama

Founded in 2007 on the principles of providing unbiased, scientifically-sound treatment options, the Stem Cell Institute has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, our comprehensive stem cell treatment protocols employ well-targeted combinations of autologous bone marrow stem cells, autologous adipose stem cells, and donor human umbilical cord stem cells to treat: multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, and autoimmune diseases. To-date, the Institute has treated over 2000 patients.

For more information on stem cell therapy:

Stem Cell Institute Website: http://www.cellmedicine.com

Stem Cell Institute
Via Israel & Calle 66
Plaza Pacific Office #2A
Panama City, Panama

Phone: +1 800 980-STEM (7836) (USA Toll-free) +1 954 636-3390 (from outside USA)
Fax: +1 866 775-3951 (USA Toll-free) +1 775 887-1194 (from outside USA)

Multiple sclerosis patient retires his walking stick after umbilical cord-derived stem cell therapy

From: mcgillron
Date: Wed, Nov 27, 2013 at 11:51 AM
Subject: Happy Thanksgiving!
To: edited_for_privacy@cellmedicine.com

Dr Barnett / Dr Hernandez & all staff at Clinic,

It’s a very special Thanksgiving for my household & I owe it to the efforts of all of you!

I’ve been walking without my stick since returning from stem cell therapy. 1 week of holding it for security & going on 3rd week of it riding in truck of my car. My stability is becoming more consistent & controlled. I am walking farther longer, riding bicycle more rhythmic & swimming smoother strokes.

Results are much greater than I expected. I believe the lifestyle changes, vitamin regimen, herbals, exercise & positive attitude adopted 14 months prior to visiting you allowed me to receive maximum benefit from the stem cell therapy.

I look forward to progressing my abilities back to a higher level over the next months.

If you would like me to share what I’ve done & am doing to get my results, feel free to give my email.

Dr Hernandez – please stay in contact on the herbal adjustments I’m making to solve final 2 deficiencies.

THANKS AGAIN for your hospitality & care!

Ron Mc Gill

Sam Harrell demonstrates his progress after receiving umbilical cord stem cells + fat stem cells for multiple sclerosis

Texas high school Hall of Fame football coach Sam Harrell talks about his progress after undergoing several stem cell treatments for secondary progressive multiple sclerosis at the Stem Cell Institute in Panama City, Panama.

Sam is speaking from the clinic in Panama while undergoing his fourth 5-day course of combination human umbilical cord-derived mesenchymal stem cells and fat-derived stromal vascular fraction cells.

"I came by myself this time and that's just a sign of how much better I've gotten. ...the last times I've come I had to get in a wheel chair [off the plane] and I just walked through the airport this time. People ask me. 'Do you think it really helps?'. Well, just look! I am walking through the airport with no aids." [Sam demonstrates how he used to walk before treatment] "I took little steps. If I needed to turn around, I had to do like this." [Sam demonstrates a slow, shuffling turn] "I don't have a rope but now I can jump rope." [sam demonstates jumping rope and walks quickly around the room demonstrating quick changes in directions] "Before, I couldn't jump rope. I couldn't do any of that. Now I can do those things. I used to have to think about my steps. I'd have to think about right leg, and left leg and now I don't have to think. I catch myself doing that. I walk somewhere and I think, 'hey I didn't have to think about walking from there to there. I just got up and walked like I used to. Now I can make quick moves. I couldn't do any of that before."

"...I coached football and I had to retire. I never thought I'd coach football again. Just this last year, I coached football again. Amazing. I thought I would never do that again. I coached this past year and I plan on doing it again. I'm thank to the Stem Cell Institute in Panama and I am thankful to God above. He's smiling on me too. It's an amazing story, I think."

Sam Harrell Texas High School Football Hall of Fame: http://www.brownwoodnews.com/index.php?option=com_content&view=article&id=10918:harrell-to-be-inducted-into-the-texas-high-school-football-hall-of-fame&catid=39:sports&Itemid=62

Links:

Stem Cell Therapy for MS

More Patient Stories