“When Dr. Ichim presented Medistem’s story to me two years ago, I was intrigued by the possibility of security and military applications of the Universal Donor adult stem cell that Medistem has discovered,” said Dr. Ray. “Since that time, Medistem has obtained FDA approval for clinical trials, numerous publications in peer-reviewed journals with top-notch Universities, and built an experienced management team. When Medistem asked for my help in assisting with strategic issues associated with value optimization and positioning in the arena of military/radioprotectant applications, I was eager to not only offer my expertise, but also to become an investor in the company.”

A native of Kentucky, Dr. Ray’s academic achievements include: B.S. in Mathematics, Physics & Chemistry, Murray State University, M.S. in Physics and Ph.D in Theoretical Physics, University of Tennessee. In addition to founding Titan Corporation, Dr. Ray has served as Executive Vice President at SAIC, Chief of the Strategic Division of the USAF and as a defense industry analyst. He is currently Chairman of the Board of Decision Sciences on the Board of Artel Corporation, and Chairman of the Cardiology Advisory Board at Scripps Clinic.

Medistem’s lead product, the Endometrial Regenerative Cell (ERC), is a stem cell that is more economical to produce, due to its unique origin, and studies suggest it is more effective than other stem cell sources. In addition to the ongoing 60 patient double-blind RECOVER-ERC clinical trial for Heart Failure and its FDA approved Critical Limb Ischemia trial, the company has been investigating possibility of using its new stem cell in protection from radiation injury. Medistem filed patent number 61/625657 covering use of ERC for radiation protection. Dr. Ray’s experience working with The Department of Defense and Homeland Security will significantly help Medistem position itself for potential military application of ERCs for radiation exposure.

“I have followed the work of Dr. Ray for some time now with great admiration,” said Thomas Ichim, CEO of Medistem. “There are few people in the world that have the unique combination of being a genuine innovator while at the same time having the talent to transform ideas into return on investment to shareholders. Dr. Ray has successfully optimized value in businesses he founded ranging from novel computer systems, to translation services, to food pasteurization, and more recently to detection of nuclear material using muon-based technology. This ability to seamlessly transverse across disciplines, while finding means of successful commercialization, suggested to us that Dr. Ray will add great value to the breadth of applications that our stem cell product may be used for.”

Commercialization of therapies for radioprotection fall under the “Animal Efficacy” rule developed by the U.S. Food and Drug Administration (FDA) in 2002 which eliminates the requirement for Phase II and Phase III clinical trials. Under this rule marketing approval is based upon efficacy studies in representative animal species and only Phase I safety data is needed. Medistem believes safety data from its current clinical trials will be sufficient in combination with animal efficacy data, thereby making the commercialization of these therapies ready for market quickly.

“We believe that Dr. Ray will be of great assistance in positioning us in the expanding market for stem cell-based therapeutics,” said Dr. Vladimir Bogin, Chairman of Medistem. “Development of novel radioprotectants in the area of cell therapy has attracted significant defense interest. The company Osiris received a $4.2 million upfront grant for large animal studies along with a procurement order of $224.7 million (http://investor.osiris.com/releasedetail.cfm?releaseid=284617) while Cellarant last year received a $153 million award for development and stockpiling of their hematopoietic progenitor cells from the Biomedical Advanced Research and Development Authority (BARDA) for use in radiation sickness (http://www.cellerant.com/pr_090110.html). We plan to seek similar contracts/grants for our ongoing work in this space.”

“It is our honor to have Dr. Ray personally invest in and join the Medistem Family. Through leveraging his experience, wisdom, and ingenuity, we are confident in accelerating the process of value optimization for our shareholders,” said Vladimir Zaharchook, Vice Chairman and Vice President of Medistem.

SAN DIEGO, CA, Apr 13, 2012 (MARKETWIRE via COMTEX) — Medistem Inc. (pinksheets:MEDS) announced today it has co-authored a peer-reviewed publication disclosing a new approach to stimulating the immune system to kill tumor cells using a novel nanotechnology-based approach.

In the publication (PLGA nanoparticle-mediated delivery of tumor antigenic peptides elicits effective immune responses. International Journal of Nanomedicine, 7: 1475, 2012) Medistem and a team of collaborators demonstrated that nanoparticles could be used to deliver molecules found on tumors to specific cells of the immune system called “dendritic cells.” These nanoparticle-loaded dendritic cells were then able to stimulate other cells of the immune system to directly kill tumors in the test tube and also in mice bearing prostate cancer.

“Cellular therapy is a clinical reality, for example, the company Dendreon developed the first therapeutic FDA-approved cancer vaccine Sipuleucel-T (Provenge) that is currently being used for treatment of patients with hormone-resistant prostate cancer. The data we published today provides ways of optimizing treatments such as Provenge,” said Dr. Vladimir Bogin, President and Chairman of Medistem. “By using nanotechnology to specifically educate dendritic cells to activate the immune system in patients, it may be possible to develop more effective ways of treating cancer by leveraging the body’s own resources.”

The senior author of the publication, Dr. Boris Minev, is faculty at the Moores Cancer Center, and at the Division of Neurosurgery of the University of California, as well as Director of Immunotherapy and Translational Oncology at Genelux Corporation. Additional collaborators included the Laboratory of Biomaterials and Nanotechnology, University of California Riverside, the Division of Neurosurgery, of University of California Los Angeles, and the Chemistry Department at San Diego State University.

“For more than 4 years, I have thoroughly enjoyed collaborating with the Medistem Team, in areas including treatment of multiple sclerosis, cancer immunotherapy, rheumatoid arthritis, and now nanotechnology. The common theme of our collaboration is leveraging the body’s own resources as a therapeutic,” said Dr. Boris Minev. “In addition to the recently announced clinical trials for Medistem’s Endometrial Regenerative Cell (ERC) universal donor stem cell, I am looking forward to clinical translation of other products of our collaboration.”

To date Medistem and Dr. Minev have published 12 peer-reviewed papers together. Dr. Minev was co-author on Medistem’s original paper describing human use of the ERC in patients with multiple sclerosis (click here for link http://www.translational-medicine.com/content/pdf/1479-5876-7-15.pdf ), as well as several other basic research and clinical publication. Medistem has filed US provisional patent # 61/592,636 covering naturally-derived nanoparticles generated by ERC.

• Entest’s McDonald Animal Hospital has treated 8 dogs in 10 Dog Pilot Study.
• All of which are showing positive results to the Stem Cell therapy.
• Osteoarthritis impacts up to 30% of all dogs

Entest BioMedical Inc. (OTCQB: ENTB.PK – News) (Pinksheets: ENTB.PK – News) and RenovoCyte LLC announced they have treated 8 canine patients of a 10 dog pilot study utilizing Canine Endometrial Regenerative Cells (CERC) licensed from Medistem Inc. (Pinksheets: MEDS.PK – News) in the treatment of canine osteoarthritis.

Previously, Entest announced the treatment of the first canine patient on November 18, 2011. Since that time Entest’s McDonald Animal Hospital has treated 8 dogs in its 10 Dog Pilot Study with RenovoCyte. To date, all of the dogs participating in this study have shown dramatic improvement in their mobility and apparent reduction of pain.

Dr. Greg McDonald, Chief Veterinarian at McDonald Animal Hospital, said, “50 million CERC stem cells have been injected intravenously into eight dogs. Each dog selected for this study showed signs of arthritis. Follow-up blood tests, urinalysis and physical exams are now being scheduled for the patients that have already been treated. So far, all these canine patients have shown improvement.”

Entest BioMedical Chairman David Koos stated, “Osteoarthritis is considered one of the most common causes of lameness in dogs, occurring in up to 30% of all dogs. It is caused by a deterioration of joint cartilage, followed by pain and loss of range of motion of the joint. We expect this treatment to relieve these animals from the pain associated with arthritis. This has extraordinary possibilities for dogs and may lead the way for human treatment of arthritic pain.”

The CERC is a “universal donor” stem cell product that does not require matching with the recipient allowing for the generation of standardized products that can be delivered to the office of the veterinarian ready for injection. This is in stark contrast to current stem cell therapies utilized in veterinary applications which require the extraction, manipulation, and subsequent implantation of tissue from the animal being treated. CERC is the canine equivalent of Medistem’s Endometrial Regenerative Cell (ERC). Medistem was recently granted approval from the FDA to initiate a clinical trial in human patients using its ERCs.

“We are extremely pleased with our research relationship with Entest BioMedical. This study of canine pets suffering from naturally occurring osteoarthritis is a better test model than laboratory induced disease because it will give us the opportunity for long term follow up of these patients. RenovoCyte sees this study as part of the supporting documentation that will be needed to obtain FDA approval for widespread usage of this therapy,” said Shelly Zacharias, DVM, Director of Veterinary Operations, RenovoCyte, LLC.

A spokesperson for Entest noted the Company is also currently conducting a 10 dog safety study on its immune-therapeutic cancer vaccine for dogs, having treated 3 dogs so far.

Dear Fellow Shareholder:

Since our last update in December 2011, we would like to comment on several important developments that have occurred and recap their implications on the successful execution of our business plan:

1. Launching of RECOVER-ERC Phase II Heart Failure Clinical Trial.
In collaboration with the Bakoulev Scientific Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences http://www.bakulev.ru/en/ and ERCell OOO, Medistem has successfully begun administering the universal donor Endometrial Regenerative Cells (ERC) stem cell product in patients with end stage heart failure.

The procedure is performed using a catheter-based retrograde administration technique which allows for localized delivery of cells without the need for surgery. The technique was invented by Dr. Amit Patel (International Principle Investigator of the Study), and safety and efficacy data of the procedure in heart failure patients has already been published (http://www.translational-medicine.com/content/pdf/1479-5876-9-183.pdf). The current trial uses this new procedure in combination with the company’s ERC product in order to develop a practical “off the shelf” stem cell therapy for heart failure that can be practiced by cardiologists world-wide. The trial is double-blind, placebo controlled, and comprises of a total of 60 patients. To date patient dosing has not been associated with any adverse events. The study is on track for completion within 18 months after initiation.

2. FDA Clearance for Phase I Critical Limb Ischemia Clinical Trial.
Medistem has received FDA clearance to initiate a 15 patient clinical trial with Dr. Michael Murphy in critical limb ischemia patients. We are currently working with Dr. Murphy and his staff preparing for initiation of the study. We are anticipating to be open for patient recruitment this May. That trial is expected to be completed in 12-18 months.

3. Collaborative Commercialization Agreement in China.
Medistem recently entered into a collaborative agreement with the Shanghai Jia Fu Medical Apparatus Corporation, a Chinese-based conglomerate with an existing cell therapy division. Under the agreement the two companies will jointly commercialize ERC in China.

4. Clinical Trials to Begin for Liver, Kidney and Lung Diseases.
A formal collaboration agreement was made with the S.M. Kirov Military Medical Academy in St. Petersburg, Russia to enter clinical trials in liver, kidney, and lung diseases.

5. Recruitment of Dr. Alan Lewis to Advisory Board.
Dr. Lewis is the previous CEO of Novocell/Viacyte, as well as the former CEO of the Juvenile Diabetes Research Foundation.

6. International Exclusivity for Yale Diabetes Technology.
Medistem signed an exclusive license agreement with Yale University covering published data and a patent application in which endometrial stem cells are used to generate insulin producing cells, as well as to treat animal models of diabetes.

7. Annual “Evening with Medistem” Event.
The company continued its annual tradition of hosting an informational event for investors and stakeholders in the field. Attendees included Dr. Warren Sherman from Columbia University, Dr. Alan Lewis, Dr. Amit Patel (via Skype) and Dr. Michael Murphy (via Skype).

8. Update on Medistem’s Stock Position.
In January 2009, Medistem made the strategic decision to voluntarily delist its stock. The rationale behind this decision was to focus company funds on developing the science and advancing our product development ahead of maintaining a public company listing. This decision alone has saved us $500,000 in annual expenses.

As a result of our voluntary delisting, outstanding shares of stock are currently trading on the PINKSHEETS under the “non-reporting” category, meaning there is no legal requirement that we file quarterly or annual reports.

Executive management of Medistem strongly believes in full transparency especially if shares are being traded on the open market. We know it is important for investors to know the total number of shares outstanding. As of March 20, 2012, the number of common shares outstanding is 6,480,440. There is no preferred stock outstanding. Because our delisting was voluntary, we will be able to relist easily when the timing for the company is right.

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.”

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

SAN DIEGO, CA and PORTLAND, OR–(Marketwire -02/28/12)- Medistem Inc. (Pinksheets: MEDS.PK – News) announced today its Annual “Evening with Medistem” Event will take place in Portland, Oregon on March 7th, 2012. The event is being hosted by Vladimir Zaharchook, Vice Chairman at Medistem, Inc., and will feature stem cell luminaries and pioneers working with Medistem including Dr. Amit Patel, Director of Regenerative Medicine at University of Utah and the first person to administer stem cells into patients with heart failure, Dr. Michael Murphy, Vascular Surgeon at Indiana University and Principal Investigator for Medistem’s FDA clinical trial in patients with risk of amputation, and Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, advisory board member of Medistem.

In 2007 Medistem discovered an entirely new type of stem cell, the Endometrial Regenerative Cell (ERC). This cell has proven it is a “universal donor” and can be used to treat many more conditions compared to other types of stem cells. The company received FDA clearance to begin clinical trials in September of 2011 for critical limb ischemia, a condition that is associated with amputation. Medistem is also running a Phase II clinical trial for heart failure using the new stem cell. The ERC stem cell does not involve the highly controversial use of fetal tissue, can be produced very economically and administered to the patient in a very simple manner. Medistem is exploring ways to expand clinical trials of its stem cell into other diseases.

“Stem cells and regenerative medicine offer hope in clinical conditions in which hope previously did not exist,” said Dr. Stanley Cohan, Head of Neurology at the St Vincent’s Hospital, the largest center for treatment of multiple sclerosis in the Pacific Northwest, who will be attending the event. “We are honored in the Portland community to have this distinguished team of accomplished researchers and medical doctors convene here and discuss with us possible collaborations.”

“As a long-time member of the Portland academic community, it is exciting to have companies such as Medistem to visit us and share their experiences ‘from the trenches’ of what it takes to push a cellular drug through the FDA,” said Dr. Shoukrat Milipotiv, Associate Scientist in the Division of Reproductive & Developmental Sciences of ONPRC, Oregon Stem Cell Center and Departments of Obstetrics & Gynecology and Molecular & Medical Genetics, and co-director of the ART/ESC core at the Center. He is an internationally recognized researcher in the area of stem cells.

“The Event is an annual celebration to honor our team and collaborators for the successes of the previous year, while at the same time educate the local business and medical community on the latest research on stem cells not just at Medistem but internationally,” said Thomas Ichim, Ph.D Chief Executive Officer of Medistem Inc. “2012 is particularly exciting for us due to approvals for two clinical trials, and the initiation of patient treatments within this context.”

SAN DIEGO, CA–(Marketwire -02/18/12)- Medistem Inc. (Pinksheets: MEDS.PK – News) announced today initiation of joint efforts with the Chinese conglomerate, Shanghai Jia Fu Medical Apparatus Inc, in developing the Endometrial Regenerative Cell (ERC) “universal donor” stem cell product for the Chinese market. The initial focus of the collaboration will be treatment of critical limb ischemia, an advanced form of peripheral artery disease. Medistem has previously received FDA clearance to begin a Phase I clinical trial using the ERC stem cells in this patient population. A scientific publication providing the rationale and supporting data for utilization of ERC in treatment of critical limb ischemia may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

“Medistem has over 10 peer-reviewed scientific papers published with academic groups from China over the past 5 years. The Team is very eager to expand our collaborations with China not only in science, but now in product development,” said Thomas Ichim, CEO of Medistem. “Given that Shanghai Jia Fu Medical Apparatus Inc is actively working in the area of clinical translation of cellular therapy, we believe this group is an ideal partner for our entry into development of therapeutics for the Chinese population.

Shanghai Jia Fu Medical Apparatus Inc currently has commercialized autologous cytokine activated killer cell therapy for cancer, as well as autologous bone marrow for treatment of critical limb ischemia; the company is interested in exploring expansion into allogeneic “off the shelf” products. As part of the initial collaboration, Medistem will provide ERC stem cells for research use and Shanghai Jia Fu Medical Apparatus Inc will support ongoing experiments. All data generated will be provided to Medistem.

“This is an example of a 2 +2 = 8 synergy,” said Mr. Wei Zhang, CEO of Shanghai Jia Fu Medical Apparatus Inc. “By leveraging cutting edge technology developed by Medistem in the context of our existing cell research and therapy infrastructure, we hope to accelerate Medistem’s development program, while at the same time bring new research to China.”

“In 2003, Dr Wei-Ping Min’s group, together with Medistem’s CEO Dr Thomas Ichim, were the first to apply the technology of RNA Interference to the immune system, by silencing the autoimmune disease-associated gene IL-12p35(2),” said Dr. Peter French. “In the current paper, Dr. Min expanded these studies to a disease-relevant model, and using stem cell-derived dendritic cells was capable of developing promising preclinical data relevant to rheumatoid arthritis.”

By specifically “silencing” various genes, Benitec Biopharma’s ddRNAi technology is capable of modulating stem cells outside of the body, in order to endow them with new desired therapeutic activities. The first clinical study which combined stem cell therapy with Benitec Biopharma’s ddRNAi technology was in a trial of AIDS-related lymphoma patients, the results of which were published in 2010 and showed the safety and feasibility of the approach(3).

In the current paper, ddRNAi was used to generate dendritic cells that acted as a “tolerogenic vaccine,” which specifically blocked the pathological immune response in rheumatoid arthritis, without blocking healthy immune responses. It is contemplated that by blocking pathological immunity, ddRNAi-modified stem cell-based therapies, such as those being developed by Medistem, could provide novel treatment and curative approaches to tissue that has been damaged. In the case of rheumatoid arthritis the tissue would be cartilage and synovium.

“Medistem is the first company to take a stem cell from discovery to clinical trials in the short span of four years,” said Dr. Weiping Min. “This is a unique example of merging basic research, as performed in my laboratory with the translational expertise of Dr. Ichim’s company.”

Medistem has previously published work in the area of rheumatoid arthritis, however the company’s main efforts are currently focused on heart failure, for which it has started the RECOVER-ERC 60 patient double blind, dose escalating, placebo controlled trial using its Endometrial Regenerative Cell (ERC) universal donor stem cell. The company also has a critical limb ischemia trial recently approved by the FDA.

“In our opinion the Benitec Biopharma technology platform is the only means of inducing the stable expression of gene silencing in a stem cell,” said Dr. Ichim, CEO of Medistem. “Given that Benitec Biopharma has pioneered ddRNAi for human therapy, and has been involved in applying it to stem cell manipulation, we are eager to continue our collaborations and finding means of leveraging the unique properties of the ERCs with the transformational technology of ddRNAi to develop novel cell therapies for a range of chronic life-threatening human diseases.”

“Benitec Biopharma and Medistem are in discussions as to how to advance this work both in rheumatoid arthritis and in a range of other disease states that would lend themselves to such a novel combination therapy,” Dr. French added.

SAN DIEGO, CA–(Marketwire -01/30/12)- Medistem Inc. (Pinksheets: MEDS.PK – News) together with its Russian Licensee, ERCell LLC, announced successful dosing of 3 heart failure patients in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The announcement was made at the Cardiovascular Stem Cell Research Symposium http://celltherapy.crf.org/.

The trial is aimed at assessing safety and efficacy of the company’s Endometrial Regenerative Cell (ERC) stem cell product in 60 heart failure patients who have no available treatment options. The “Universal Donor” adult stem cells will be administered using a novel catheter-based retrograde administration methodology that directly implants cells in a simple, 30 minute, procedure. A recent publication describing 2-year follow-up of angina patients administered bone marrow cells treated with the “retrograde procedure” authored by Dr. Amit Patel of the University of Utah, the International Principle Investigator of the trial, may be obtained at http://www.translational-medicine.com/content/pdf/1479-5876-9-183.pdf.

“We are honored to have had the opportunity to present at the prestigious Cardiovascular Stem Cell Research Symposium, alongside companies such as Athersys, Aastrom, Pluristem, Cardio3, Cytori, and Mesoblast,” stated Thomas Ichim, CEO of Medistem. “The RECOVER-ERC trial is the first trial combining a novel stem cell, with a novel administration procedure. Today cardiac administration of stem cells is relatively invasive and can only be performed at specialized institutions, we feel the retrograde procedure will circumvent this hurdle.”

Medistem’s ERC stem cell product is different from other adult stem cells in that it is derived from the endometrium (lining of the uterus). The endometrium grows every month before menstruation, in anticipation of implantation. The growth of the endometrium is associated with a very high degree of new blood vessel production, a process called angiogenesis. Conditions such as heart failure, and peripheral artery disease occur because of reduced circulation to the heart or legs. Medistem believes that by implanting ERC, the body will generate new blood vessels that will increase circulation. Proof of concept animal studies supporting the use of these cells in critical limb ischemia http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf, and cardiac damage http://onlinelibrary.wiley.com/doi/10.1634/stemcells.2007-0826/pdf have been published in the peer reviewed literature.

Medistem recently obtained FDA clearance to begin Phase I trials in the US for treatment of critical limb ischemia, an advanced form of peripheral artery disease, which causes approximately 150-200,000 amputations per year in the USA. The trial will be conducted by Dr. Michael Murphy at Indiana University.

“Heart failure is one of the major scourges on the Russian population. We are extremely pleased that that the pioneering work Medistem has been performing in the USA, is now being conducted in Russia through Medistem’s licensee ERCell LLC,” said Dr. Olga Bockeria, Professor of Cardiology at the Bakulev Center for Cardiovascular Surgery, the site conducting the trial.

Tereza Ustimova, CEO of ERCell LLC, who has signed an exclusive license/technology transfer agreement for use of Medistem’s ERC product in Russia, stated, “It has been a pleasure to work with the teams of Dr. Leo Bockeria, Principle Investigator and Dr. Amit Patel the International Principle Investigator begin the first clinical trial of a ‘Universal Donor’ stem cell in Russian history.”

“It is critical to emphasize that the stem cells used here are from healthy adult volunteers that have been screening according to strict criteria and do not involve embryonic or fetal tissue,” said Sergey Volzhenkin, Board Member of ERCell. “Given that under current manufacturing processes one donor generates 20,000 patient doses, we believe that we are not only developing a stem cell therapy, but an actual drug that can be manufactured inexpensively, distributed extensively, and administered at the patient’s bedside without need for complicated procedures.”

Although this is the first formal clinical trial assessment of the ERC stem cell in cardiac conditions, Medistem and international collaborators published a peer reviewed paper in 2010 describing the first use of ERC in a heart failure patient. The manuscript is freely available at the following link: http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf.

“I am pleased with the smooth technology transfer process and agility that ERCell exhibited in working with Bakulev on making our clinical trial a reality,” stated Vladimir Zaharchook, Vice Chairman and Vice President of Medistem.

The RECOVER-ERC TRIAL

The clinical trial will recruit 60 patients with congestive heart failure, which will be randomized into 3 groups of 20 patients each. Group 1 will receive 50 million ERC, Group 2 will receive 100 million and Group 3 will receive 200 million. Cells will be administered via catheter-based retrograde administration into the coronary sinus, a 30 minute procedure developed by Dr. Amit Patel’s Team. Each group will comprise of 15 patients receiving cells and 5 patients receiving placebo. Efficacy endpoints include ECHO and MRI analysis, which will be conducted at 6 months after treatment. The trial design is similar to the recent Mesoblast Phase II cardiac study, in order to enable comparison of efficacy.