Medistem - Coming Of Age?
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The endometrial regenerative cell, or ERC for short, is a "universal donor" stem cell derived from the menstrual blood that possesses the ability to become brain, lung, liver, bone, cartilage, pancreatic, fat, muscle, heart and blood vessel tissue. The ERC is known to possess certain advantages over embryonic or adult stem cells in that it is easy to isolate , administer, does not require donor-recipient matching and above all, it is non-controversial.
In 2009, the FDA placed a clinical hold on Medistem's phase I trial evaluating its ERC stem cell product in treating patients with critical limb ischemia who have no options but amputation. The company was required to provide additional animal data before it could go ahead with human testing.
After conducting additional preclinical studies requested by the FDA regarding its cellular product, the company filed its response to the regulatory clinical hold on its phase I clinical trial application last month. The studies were supported by a federal SBIR (Small Business Innovative Research) grant.
Yesterday, (Sep.22) Medistem received FDA approval to initiate a dose-escalating clinical trial in patients with critical limb ischemia using its ERC stem cell product, joining a small list of companies that have Federal permission to utilize adult stem cell products under experimental basis in American patients.
Critical limb ischemia, or CLI, is an advanced form of peripheral artery disease manifested by severe obstruction of the arteries which seriously decreases blood flow to hands, feet and legs. In its worst instances, CLI could lead to amputations.
Currently, surgical bypass or revascularisation (the use of stents or balloons) are done to improve blood flow in CLI patients and prevent amputation. On an annual basis, CLI accounts for nearly 200,000 amputations.
Medistem has an agreement in place with cellular medicine company RenovoCyte LLC that was signed earlier this year, under which RenovoCyte has an exclusive license to use Medistem's endometrial regenerative cells for veterinary applications. In May of 2011, Medistem inked a collaboration with the Bakoulev Center of Cardiovascular Surgery of Russian Academy of Sciences to focus on clinical development of Endometrial Regenerative Cell stem cell for treatment of patients with heart failure.
Medistem will be presenting new safety results from cardiac patients treated with the its ERC universal donor stem cell product at the upcoming World Stem Cell Summit Oct 3-4 in Pasadena, California.
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