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Stemedica moving forward with trials for stroke treatment

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Stemedica Cell Technologies Inc. announced Thursday that it has completed meetings with the FDA and plans to go ahead with studies on a new stroke treatment.

Stemedica, which is based in San Diego and conducts stem cell research and manufacturing, is going forward with safety and efficacy studies of its high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells as a treatment for ischemic stroke.

Based on an Oct. 13 meeting with the FDA, Stemedica is planning to file an investigative new drug (IND) application in the first quarter of 2010.

The proposed clinical trial will be a Phase 1/2 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.

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