Aastrom Biosciences Inc. announced that the company will initiate its second clinical trial for the treatment of dilated cardiomyopathy (DCM), a severe disease associated with chronic heart failure, after a positive 30-day review of Aastrom's Investigational New Drug (IND) submission by the U.S. Food & Drug Administration (FDA). This second trial is a 24 patient U.S. Phase II clinical trial to evaluate the catheter delivery of Cardiac Repair Cells (CRCs) for the treatment of DCM. The new trial expands the Company's cardiovascular program that includes a U.S. Phase II IMPACT-DCM clinical trial evaluating the direct surgical delivery of CRCs. The FDA previously granted CRCs an Orphan Drug Designation for the treatment of DCM. The randomized, controlled, prospective, open-label, Phase II study will seek to enroll 12 patients with ischemic DCM and 12 patients with non-ischemic DCM at two clinical sites in the U.S. Participants must have a left ventricular ejection fraction of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. All 24 patients will receive standard medical care and 16 of the patients (8 ischemic and 8 non-ischemic) will also be treated with CRCs via catheter injection. While the primary objective of this study is to assess the safety of CRCs delivered by catheter injection in patients with DCM, efficacy measures including heart failure stage and cardiac function parameters will also be assessed. Patients will be followed for 12 months post treatment.

Aastrom Biosciences Inc. reported unaudited consolidated earnings results for the first quarter ended September 30, 2009. The company reported total revenues for the quarter ended September 30, 2009, consisting of product sales, were $73,000 compared to total revenues of $27,000 for the same period in fiscal year 2009. Net loss was $3,801,000, or $0.02 per common share compared to $3,913,000, or $0.03 per common share for the same period in fiscal year 2009. The changes in net loss is primarily the result of fluctuations in spending of research and development expenses, and in part on a per share basis by an increase in the weighted average number of common shares outstanding. The company announced that Harold C. Urschel, Jr., M.D. was elected to the Board of Directors on October 14, 2009. Dr. Urschel is currently Chair of Cardiovascular & Thoracic Surgical Research, Education & Clinical Excellence at Baylor University Medical Center in Dallas, Texas. In addition, Dr. Urschel served on the Board of Directors of Electronic Data Systems from inception until it was acquired by General Motors. George W. Dunbar is expected to assume the role of Chairman of the Board immediately after the Annual Meeting of Shareholders on December 14, 2009.

To discuss on surgical applications of angiogenesis and myogenesis