San Diego, CA -
Medistem Inc has announced in the press release below that it has filed an Investigational New Drug (IND) application with the FDA for use of its Endometrial Regenerative Cells (ERC) for the treatment of critical limb ischemia.
The Principle Investigator for the proposed study Dr. Michael Murphy from Indiana University has previously performed trials in critical limb ischemia using adult stem cells at Indiana, and also was lead author on a publication with Medistem describing the rationale for use of ERC in critical limb ischemia.
SAN DIEGO, CA and PHOENIX, AZ--(Marketwire - December 22, 2008) - Medistem Inc. (OTCBB: MEDS) announced today it has filed an Investigational New Drug (IND) Application with the United States Food and Drug Administration to undertake clinical studies using its proprietary endometrial regenerative cells (ERC) in patients with an advanced form of peripheral artery disease termed "critical limb ischemia." The IND application seeks permission from the FDA to administer ERC to 10 patients having specific inclusion/exclusion criteria and will focus primarily on gathering safety information; however, markers of efficacy will also be evaluated. The principal investigator of the proposed clinical trial is Dr. Michael Murphy from Indiana University.
About Medistem Inc.
Medistem Inc. is a biotechnology company founded to develop and commercialize 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 derived from the menstrual blood that possesses the ability to differentiate into nine tissue types, produce large quantities of growth factors, and a large proliferative capacity. A peer reviewed publication describing this novel cell type may be found at http://www.translational-medicine.com/content/5/1/57. The company is currently focusing on use of endometrial regenerative cells for treatment of critical limb ischemia, an advanced form of peripheral artery disease.
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.