Leo Bockeria, Vladimir Bogin, Olga Bockeria, Tatyana Le, Bagrat Alekyan, Erik J Woods, Amalia A Brown, Thomas E Ichim and Amit N Patel
Journal of Translational Medicine 2013, 11:56 doi:10.1186/1479-5876-11-56
Published: 5 March 2013
Heart failure is one of the key causes of morbidity and mortality world-wide. The recent findings that regeneration is possible in the heart have made stem cell therapeutics the Holy Grail of modern cardiovascular medicine. The success of cardiac regenerative therapies hinges on the combination of an effective allogeneic “off the shelf” cell product with a practical delivery system. In 2007 Medistem discovered the Endometrial Regenerative Cell (ERC), a new mesenchymal-like stem cell. Medistem and subsequently independent groups have demonstrated that ERC are superior to bone marrow mesenchymal stem cells (MSC), the most widely used stem cell source in development. ERC possess robust expansion capability (one donor can generate 20,000 patients doses), key growth factor production and high levels of angiogenic activity. ERC have been published in the peer reviewed literature to be significantly more effect at treating animal models of heart failure (Hida et al. Stem Cells 2008).Current methods of delivering stem cells into the heart suffer several limitations in addition to poor delivery efficiency. Surgical methods are highly invasive, and the classical catheter based techniques are limited by need for sophisticated cardiac mapping systems and risk of myocardial perforation. Medistem together with Dr. Amit Patel Director of Clinical Regenerative Medicine at University of Utah have developed a novel minimally invasive delivery method that has been demonstrated safe and effective for delivery of stem cells (Tuma et al. J Transl Med 2012). Medistem is evaluating the combination of ERC, together with our retrograde delivery procedure in a 60 heart failure patient, double blind, placebo controlled phase II trial. To date 17 patients have been dosed and preliminary analysis by the Data Safety Monitoring Board has allowed for trial continuation.The combined use of a novel “off the shelf” cell together with a minimally invasive 30 minute delivery method provides a potentially paradigm-shifting approach to cardiac regenerative therapy.
http://www.translational-medicine.com/content/11/1/56/abstract
Showing posts with label endometrial stem cells. Show all posts
Showing posts with label endometrial stem cells. Show all posts
Tuesday, March 12, 2013
Monday, January 14, 2013
Medistem Inc. Annual Letter to Shareholders
SAN DIEGO, CA–(Marketwire – Jan 4, 2013) – Medistem Inc. ( PINKSHEETS : MEDS ) today issues the following letter to shareholders.
Dear Fellow Shareholders,
2012 was marked by significant progress in the development of the Endometrial Regenerative Cell (ERC), our new universal donor “stem cell drug.” Most significantly, we initiated a double blind, placebo controlled clinical study in patients with end stage heart failure, in which ERC were administered via the Medistem’s patent-pending minimally invasive procedure. The clinical trial comprises three escalating doses of ERC with cohorts of 20 patients per dose. To date 14 patients have been treated with no adverse effects, thus demonstrating feasibility of the administration procedure, as well as safety of the cells. Because it is a double blind study, efficacy will not be known until the trial is completed. The clinical trial is being conducted at the Backulev Center for Cardiovascular Surgery in Moscow, Russia, by Academician Leo Bockeria. The company also initiated a 15 patient critical limb ischemia trial in China in collaboration with Shanghai Jia Fu Medical Apparatus Inc. To date two patients have been treated. The trial is based on the Medistem critical limb ischemia study that has been cleared by the FDA.
In addition, we licensed from Yale University the world-wide rights for a patent application using ERC to treat Type 1 diabetes. We also initiated a program in type 1 diabetes, with the goal of filing an Investigational New Drug application before the end of 2013 to allow for clinical trial initiation.
In 2012, researchers at the National Institutes of Health (NIH) independently verified and published a peer reviewed article confirming ERC possess a markedly higher expression of genes associated with new blood vessel formation and stem cell potency compared to bone marrow mesenchymal stem cells. The publication may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf
In addition, our intellectual property was further enhanced with the issuance of patent #8,241,621 covering the use of fat derived stem cells for treatment of autoimmune conditions such as rheumatoid arthritis, type 1 diabetes, and multiple sclerosis. We have also filed 2 patent applications covering the use of ERC for radiation protection and treatment of traumatic brain injury.
Also, in collaboration with several corporate and academic institutions we published a total of 7 peer reviewed papers in 2012 on collaborative breakthroughs we made in the areas of hepatitis, cancer, and prevention of transplant rejection.
Additionally, this year we added two new advisory board members including Gene Ray, Ph.D., and Alexander Gershman, M.D., Ph.D. Dr. Ray was founder of the Titan Corporation, where he served as CEO and a director of the corporation since the company’s inception in 1981. In 2011, Titan Corporation was acquired by L-3 Communications for $2.6 billion. Dr. Gershman is one of the first surgeons in the world to apply the method of laparoscopic surgery and robotic-assisted surgery to urology. He currently holds several hospital appointments, including: Director of Institute of Advanced Urology at the Cedars-Sinai Medical Center; Director of Urologic Laparoscopy in the Division of Urology, and Harbor-UCLA Medical Center.
Finally, this year marked a major transition in the leadership of the company. I was appointed to the position of CEO on October 26 and Dr. Thomas Ichim transitioned to the position of President and Chief Scientific Officer. Dr. Ichim has done an outstanding job leading the company for the past four years and I look forward to working closely with him at commercializing the ERC product.
In 2013 our objective will be to meet the following milestones:
•Return to “fully reporting” status and listing on the OTCBB
•Appointment of at least one new board member
•Initiation of the FDA cleared critical limb ischemia trial in the USA
•Completing enrollment in the RECOVER-ERC double blind cardiac trial
•Filing an IND for type 1 diabetes.
I want to end by thanking our loyal shareholders for their continued support as Medistem continues on its mission to generate the first practical “stem cell medicine.”
Sincerely Yours,
Dr. Alan Lewis
Chief Executive Officer
Medistem Inc.
About Medistem
Medistem Inc. is focused on the development of the Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product. ERCs possess specialized abilities to stimulate new blood vessel growth and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERCs have been cleared by the FDA to begin studies in the United States.
ERCs have several distinguishing advantages to other stem cell therapies: a) Non-invasive method of collection; b) Unlimited supply of cells; isolated from menstrual blood of young healthy donors; c) Economical and scalable to manufacture; d) Exert higher therapeutic activity compared to other stem cells; and e) demonstrated safe in animal and pilot human studies.
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, Ph.D.
President and Chief Scientific Officer
Medistem Inc.
9255 Towne Centre Drive
Suite 450
San Diego, CA 92122
858 349 3617
www.medisteminc.com
Dear Fellow Shareholders,
2012 was marked by significant progress in the development of the Endometrial Regenerative Cell (ERC), our new universal donor “stem cell drug.” Most significantly, we initiated a double blind, placebo controlled clinical study in patients with end stage heart failure, in which ERC were administered via the Medistem’s patent-pending minimally invasive procedure. The clinical trial comprises three escalating doses of ERC with cohorts of 20 patients per dose. To date 14 patients have been treated with no adverse effects, thus demonstrating feasibility of the administration procedure, as well as safety of the cells. Because it is a double blind study, efficacy will not be known until the trial is completed. The clinical trial is being conducted at the Backulev Center for Cardiovascular Surgery in Moscow, Russia, by Academician Leo Bockeria. The company also initiated a 15 patient critical limb ischemia trial in China in collaboration with Shanghai Jia Fu Medical Apparatus Inc. To date two patients have been treated. The trial is based on the Medistem critical limb ischemia study that has been cleared by the FDA.
In addition, we licensed from Yale University the world-wide rights for a patent application using ERC to treat Type 1 diabetes. We also initiated a program in type 1 diabetes, with the goal of filing an Investigational New Drug application before the end of 2013 to allow for clinical trial initiation.
In 2012, researchers at the National Institutes of Health (NIH) independently verified and published a peer reviewed article confirming ERC possess a markedly higher expression of genes associated with new blood vessel formation and stem cell potency compared to bone marrow mesenchymal stem cells. The publication may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf
In addition, our intellectual property was further enhanced with the issuance of patent #8,241,621 covering the use of fat derived stem cells for treatment of autoimmune conditions such as rheumatoid arthritis, type 1 diabetes, and multiple sclerosis. We have also filed 2 patent applications covering the use of ERC for radiation protection and treatment of traumatic brain injury.
Also, in collaboration with several corporate and academic institutions we published a total of 7 peer reviewed papers in 2012 on collaborative breakthroughs we made in the areas of hepatitis, cancer, and prevention of transplant rejection.
Additionally, this year we added two new advisory board members including Gene Ray, Ph.D., and Alexander Gershman, M.D., Ph.D. Dr. Ray was founder of the Titan Corporation, where he served as CEO and a director of the corporation since the company’s inception in 1981. In 2011, Titan Corporation was acquired by L-3 Communications for $2.6 billion. Dr. Gershman is one of the first surgeons in the world to apply the method of laparoscopic surgery and robotic-assisted surgery to urology. He currently holds several hospital appointments, including: Director of Institute of Advanced Urology at the Cedars-Sinai Medical Center; Director of Urologic Laparoscopy in the Division of Urology, and Harbor-UCLA Medical Center.
Finally, this year marked a major transition in the leadership of the company. I was appointed to the position of CEO on October 26 and Dr. Thomas Ichim transitioned to the position of President and Chief Scientific Officer. Dr. Ichim has done an outstanding job leading the company for the past four years and I look forward to working closely with him at commercializing the ERC product.
In 2013 our objective will be to meet the following milestones:
•Return to “fully reporting” status and listing on the OTCBB
•Appointment of at least one new board member
•Initiation of the FDA cleared critical limb ischemia trial in the USA
•Completing enrollment in the RECOVER-ERC double blind cardiac trial
•Filing an IND for type 1 diabetes.
I want to end by thanking our loyal shareholders for their continued support as Medistem continues on its mission to generate the first practical “stem cell medicine.”
Sincerely Yours,
Dr. Alan Lewis
Chief Executive Officer
Medistem Inc.
About Medistem
Medistem Inc. is focused on the development of the Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product. ERCs possess specialized abilities to stimulate new blood vessel growth and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERCs have been cleared by the FDA to begin studies in the United States.
ERCs have several distinguishing advantages to other stem cell therapies: a) Non-invasive method of collection; b) Unlimited supply of cells; isolated from menstrual blood of young healthy donors; c) Economical and scalable to manufacture; d) Exert higher therapeutic activity compared to other stem cells; and e) demonstrated safe in animal and pilot human studies.
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, Ph.D.
President and Chief Scientific Officer
Medistem Inc.
9255 Towne Centre Drive
Suite 450
San Diego, CA 92122
858 349 3617
www.medisteminc.com
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.
Sincerely
Tom
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
www.medisteminc.com
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.
Contacts
Medistem Inc.
Thomas Ichim
President and Chief Scientific Officer
858-349-3617
Thomas.ichim@medisteminc.com
www.medisteminc.com
twitter: @thomasichim
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.
Sincerely
Tom
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
www.medisteminc.com
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.
Contacts
Medistem Inc.
Thomas Ichim
President and Chief Scientific Officer
858-349-3617
Thomas.ichim@medisteminc.com
www.medisteminc.com
twitter: @thomasichim
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.
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
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
Wednesday, June 6, 2012
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
www.medisteminc.com
twitter: @thomasichim
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
www.medisteminc.com
twitter: @thomasichim
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.
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.
Contact:
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.
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.
Contact:
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.
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