Product is being developed as an “off the shelf” treatment for use in combat and emergencies.
Medistem formed a partnership to evaluate its endometrial regenerative cell (ERC) therapy for traumatic brain injury with C.S. Chen, M.D., Ph.D., head of the division of oncology and hematology of Loma Linda University and Anatol Manaenko, Ph.D., at Zhang Neuroscience Research Laboratories. Dr. Chen, Dr. Manaenko, and scientists from the company will conduct animal studies to assess the stem cell product.
“It’s my vision that one day we will have ready-to-use frozen stockpiles of ERCs for rapid treatment of serious brain injury in both civilian and military applications,” says Vladimir Bogin, M.D., chairman of Medistem. To date, preliminary data from the collaboration suggests behavioral improvements within 24, 48, and 72 hours after administration of the cells in animals subjected to intracerebral hemorrhage, a consequence of severe traumatic brain injury.
The ERC stem cell population originates from the endometrium, which renews itself 500 times during a person’s life. Medistem originally reported the existence of these cells in a peer-reviewed publication in 2007 where the company and academic collaborators demonstrated higher production of growth factors as compared to other adult stem cells including cord blood and bone marrow. Additionally, Medistem published that ERCs caused no side effects in four patients administered ERC intrathecally. While cancer formation/acceleration is a concern regarding cell therapies, Medistem reports that peer-reviewed data suggests ERCs actually inhibit glioma.
“From the drug development perspective, ERCs appear ideal in that: a) they do not require matching with the recipient, thus making them an ‘off the shelf’ product that can be shipped to the site of use and stockpiled indefinitely until they are needed; b) they produce high concentrations of growth factors, that at least theoretically would accelerate the process of tissue regeneration/healing; c) they have the capability of differentiating into neural tissue; and d) they are economical to produce,” said Dr. Chen. “Given that the company holds an FDA IND for use of the ERC in critical limb ischemia and is also conducting a Phase II double-blind, placebo-controlled trial for treatment of end-stage heart disease, we feel confident in the feasibility of clinically translating these initial findings.”