First Two Patients Treated With ERC Universal Donor Stem Cells in Critical Limb Ischemia Study
SAN DIEGO, CA–(Marketwire -07/13/12)- Medistem Inc. (MEDS) and the Chinese Conglomerate, Shanghai Jia Fu Medical Apparatus Inc, announced today successful administration of Medistem’s Endometrial Regenerative Cell (ERC) universal donor stem cell product in 2 patients with critical limb ischemia as part of a 15 patient study. The ERC dosing procedure, which involves a series of intramuscular injections in the ischemic limb, was successfully performed, without any treatment-associated adverse effects observed in either patient.
“The ERC is unique amongst clinical grade stem cells in that the cell is derived from the endometrium (lining of the uterus). Every month new blood vessels are formed in the endometrium, which subsequently are sloughed off during menstruation. We believe the ERC plays a critical role in forming new blood vessels, which is supported by numerous experiments we have conducted,” said Thomas Ichim, CEO of Medistem. “Since the biological role of the ERC is to produce new blood vessels, it is our desire to use these cells to produce new blood vessels in the legs of patients with critical limb ischemia.”
Critical limb ischemia is an advanced form of peripheral artery disease that causes approximately 150-200,000 amputations per year in the USA. Dr. Michael Murphy of Indiana University, Principle Investigator for Medistem’s FDA cleared clinical study on critical limb ischemia has previously published with Medistem data and rationale supporting the use of ERC for treatment of this condition. The publication may be found on this link:
“Due to the high incidence of diabetes in the Chinese population, critical limb ischemia is a significant cause of suffering in our country,” said Mr. Wei Zhang, CEO of Shanghai Jia Fu Medical Apparatus Inc. “We are optimistic that the lessons we have learned from successfully commercializing DC-CIK can be applied to the first universal donor stem cell that is extracted from the endometrium.”
The current work in China is based on the interests of Shanghai Jia Fu Medical Apparatus Inc to expand their clinical cellular therapy portfolio, which is currently based on DC-CIK, an autologous immunotherapy for cancer patients. Medistem and Shanghai Jia Fu intend to develop the ERC product in China by performing a series of clinical trials with the goal of obtaining marketing approval.
“We are extremely optimistic about our collaboration, given that the clinical trial is well underway,” said Feng Lin, Medistem’s Director of Chinese Operations. “Under the current arrangement, Medistem has access to all data generated as part of this clinical trial, as well as to numerous medical and business relations, which are the key to successful expansion into China.”