Medistem Receives FDA Approval to Begin Clinical Trial in USA With ERC Stem Cells

Medistem - Coming Of Age?

(RTTNews) - Biotechnology company Medistem Inc. has hit a milestone , following regulatory approval to begin a clinical trial in the U.S. with its lead product candidate endometrial regenerative cell stem cell product.

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.

After nearly four years, Medistem has finally succeeded in taking its stem cell product from discovery to FDA clinical trial approval. How the trial pans out will remain the big story.

Press Release

Medistem Receives FDA Approval to Begin Clinical Trial in USA With ERC Stem Cells

23 Sep 2011

Medistem announced 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

SAN DIEGO, CA, USA September 23, 2011 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."

About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pd f. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/ ?page=catalog_endometrial_regenerative_cells.
SOURCE: Medistem Inc.