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FDA Approves Stemedica Cell Technologies, Inc. IND for Ischemic Stroke Clinical Trial



4/21/2010 8:36:45 AM

SAN DIEGO, April 20 /PRNewswire/ -- Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica's high potency proprietary allogeneic stem cells (adult human).

The IND application approval allows Stemedica to initiate a planned clinical trial at medical centers within the United States. The 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 significant functional or neurologic impairment related to the ischemic stroke 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.

Stemedica is licensed by the State of California's Department of Public Health, Food and Drug Branch to manufacture stem cells, drugs and biologic products for human clinical trials. The Company is compliant with both California law and the Code of Federal Regulations.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

CONTACT: Dave McGuigan, Stemedica Cell Technologies, Inc., 1-858-658-0910,
dmcguigan@stemedica.com

Web site: http://www.stemedica.com/


Read at BioSpace.com


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