Stemedica Requests Pre-IND Meeting With FDA

Main Category: Stroke
Also Included In: Stem Cell Research;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 22 Aug 2009 - 1:00 PDT

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Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") to discuss a proposed IND to use Stemedica's proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

Stroke is a leading cause of adult impairment, with 20% of stroke survivors requiring institutional care after 3 months and up to 30% severely and permanently disabled. The only approved treatments of acute ischemic stroke involves restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics (tPA) is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy.

"Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy," said Nikolai Tankovich, MD, PhD, President & Chief Medical Officer. "Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

Allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica's cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch. "Stemedica's facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials," said Maynard Howe, PhD, Vice Chairman and CEO of Stemedica.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

Source: Stemedica Cell Technologies, Inc

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