SAN DIEGO, CA — (Marketwire -09/22/11)- Medistem Inc. (Pinksheets: MEDS.PK – News) announced today approval from the FDA to initiate a dose-escalating clinical trial in patients with critical limb ischemia using its Endometrial Regenerative Cell (ERC) stem cell product. This approval puts Medistem in a small list of companies that have Federal permission to utilize adult stem cell products under experimental basis in American patients. The company has secured funds from private investors to begin the clinical trial.
“The endometrial origin of the ERC makes this the first stem cell product approved by the FDA for human testing that comes from a new source of tissue,” said Dr. Amit N. Patel, Director of Cardiovascular Regenerative Medicine at Utah University and Principle Investigator of the cardiovascular trials. “Given that the natural role of the endometrium is to generate new blood vessels every month, we are hopeful that these cells will be not only angiogenic but actually vasculogenic.”
Medistem is treating critical limb ischemia, an advanced form of peripheral artery disease that causes approximately 200,000 amputations per year. Dr. Murphy was the first to use bone marrow stem cells for treating this condition in the USA and is currently running a Phase III pivotal trial for another company.
“This marks a historic day for Medistem, in that we were able to take a cell from discovery to FDA clinical trial approval in 4 years,” said Dr. Vladimir Bogin, Chairman of Medistem. “Today’s milestone, combined with the heart failure study with Dr. Patel and Dr. Leo Bockeria at the Backulev Center for Cardiovascular Surgery, positions us to rapidly deploy the ERC for multiple therapeutic indications.”
Dr. Michael Murphy at University of Indiana, who is the Principle Investigator of the critical limb ischemia trial, stated, “Based on our animal data, the ERC is the most potent amongst adult stem cells at creating new blood vessels in ischemic tissue. We are highly interested in the outcome of this study.”