SOURCE: Medistem Inc.

Medistem Inc.

September 22, 2011 17:53 ET

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

SAN DIEGO, CA--(Marketwire - Sep 22, 2011) - Medistem Inc. (PINKSHEETS: MEDS) 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.pdf. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

Contact Information

  • Contact:
    Thomas Ichim
    Chief Executive Officer
    Medistem Inc.
    9255 Towne Centre Drive, Suite 450
    San Diego, CA 92122
    858 349 3617
    858 642 0027
    www.medisteminc.com
    twitter: @thomasichim

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