FDA Clears Aldagen to Test Stem Cell Treatment for Strokes

Jan 07, 2011   

Aldagen, Inc. announced yesterday that the FDA has cleared its investigational new drug (IND) application, allowing the biopharmaceutical company to proceed with phase II clinical trials. The focus of the clinical trials will be on the development of a stem cell therapy for treatment of stroke patients.

Currently, treatments for stroke sufferers are limited and largely restricted to the use of anti-coagulants. While these anti-coagulants must be administered within hours of a stroke, the stem cell therapy that Aldagen is developing is administered approximately two weeks after the patient has suffered a stroke. Because the therapy will lengthen the time for which treatment options are available to patients, the stem cell therapy may provide care to a greater patient population than traditional drug products could serve.

Earlier this week, we reported the FDAs clearance of another stem cell trial. With this newest IND clearance, it appears that stem cell treatment options are finally making headway with the FDA.
For more information on the FDA regulatory framework regarding stem cells or the Investigational New Drug process, please contact us at contact@fidjlaw.com.