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news.Medistem, an adult stem cell biotechnology company, has filed an investigational new drug application with the FDA to undertake clinical studies using its proprietary endometrial regenerative cells in patients with an advanced form of peripheral artery disease termed 'critical limb ischemia'.
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The investigational new drug (IND) application seeks permission from the FDA to administer endometrial regenerative cells to 10 patients having specific inclusion or 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 Michael Murphy from Indiana University.