DAVID GRANOVSKY

Stemedica Completes Meeting With FDA

In ALL ARTICLES on October 16, 2009 at 3:07 am

SAN DIEGO, Oct. 15 /PRNewswire/ — Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica’s high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010. The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.

The patient population will include individuals with a clinical diagnosis of chronic neurological or age-related neurodegenerative disease with significant functional or neurologic impairment that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.

via Stemedica Completes Meeting With the FDA | Reuters.

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