FDA Approves Stemedica IND for Ischemic Stroke Clin... ( Stemedica Ce...)

FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial

Date:4/20/2010

Stemedica Cell Technologies, Inc. (Stemedica) 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).

San Diego, California (PRWEB) April 20, 2010 -- 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 FDA acceptance of our IND application and the clinical protocol for usage of allogeneic mesenchymal bone marrow-derived stem cells in subjects with ischemic stroke is an important milestone for Stemedica in its development program,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “Currently, patients suffering from ischemic stroke have very limited treatment options. We hope that bringing this novel option to the medical community will help to alleviate the burden of a serious and disabling disease and will be valuable for both patients and their family members.”

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 wheelchai
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