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Aastrom Resumes Clinical Trial Following FDA Clearance

Forbes, June 18, 2009

The adult stem cell company Aastrom Biosciences has resumed patient enrollment in its Phase II clinical trial, entitled IMPACT-DCM, in which autologous adult stem cells are being used to treat dilated cardiomyopathy, an end-stage form of chronic, congestive heart failure. The study had been suspended on May 22 when a patient in the trial died. The U.S. Food and Drug Administration has now concluded that the death of the patient was unrelated to the clinical trial.

On May 22 it was announced that the clinical trial was suspended when a patient who was enrolled in the trial unexpectedly died after having been treated with autologous (in which the donor and recipient are the same person) adult stem cells and released from the hospital. The FDA then imposed a halt on the clinical trial, at which time Aastrom temporarily suspended further patient enrollment and treatment until the cause of death could be determined. Having completed its formal investigation, the FDA has now concluded that the cause of the patient's death was unrelated to the clinical trial itself, but instead was merely caused by the advanced stage of the patient's own dilated cardiomyopathy. Since the clinical trial was specifically designed to treat dilated cardiomyopathy, this disease was required as a preexisting condition for enrollment in the clinical trial, although some patients who were enrolled had more advanced and severe forms of this condition than others.

Fourteen people have been enrolled in the study thus far, which has a target enrollment of 40 patients. The dilated cardiomyopathy study is not Aastrom's only clinical trial currently underway, however, as Aastrom is also conducting a Phase IIb clinical trial for the treatment of critical limb ischemia, an advanced form of peripheral artery disease, which is also being treated with autologous adult stem cells. According to the Aastrom's website, "The Company's proprietary Tissue Repair Cell (TRC) technology involves the use of a patient's own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom's TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient." Aastrom describes itself as a "Regenerative medicine company developing personalized cell-based therapies to slow or reverse the course of chronic diseases." As stated on their website, "Aastrom's TRC products have been used in over 325 patients, and are currently in clinical trials for cardiac, vascular and bone tissue regeneration applications, with plans to expand into the neural therapeutic area."

Headquartered in Ann Arbor, Michigan, Aastrom is focused exclusively on therapies that are developed from autologous adult stem cells, not embryonic stem cells.

Aastrom's stock price climbed 21.8% following today's news announcement by the FDA.



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