ANN ARBOR, Mich., May 3, 2010 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that positive interim results from the company's U.S. Phase 2b trial designated RESTORE-CLI has been accepted for presentation at this year's Vascular Annual Meeting^® of the Society for Vascular Surgery. These promising interim results will be presented by Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the study.

Dr. Powell's presentation, entitled "Interim Results from a Randomized, Placebo Controlled, Double-blind Multi-center Phase II Trial Comparing Expanded Autologous Bone Marrow in Patients with Critical Limb Ischemia," will further describe the interim results based on data from 46 patients enrolled in the RESTORE-CLI trial. Top-line results had previously been released on February 24, 2010. The study abstract states that "[a]utologous stem cell therapy using TRCs appears safe and has a beneficial effect on lower extremity outcome when compared to placebo in patients with CLI and no revascularization options."

The presentation will take place at 2:18 PM on June 11 at the Hynes Convention Center in Boston, MA. Abstract available at http://www.vascularweb.org/Annual_Meeting/Abstracts/2010/LB5.html.

RESTORE-CLI is the largest double-blind, randomized cell therapy study to be conducted for critical limb ischemia or CLI, the end-stage of peripheral arterial disease. The purpose of this trial has been to assess the safety and clinical efficacy of Aastrom's tissue repair cells (TRCs) in the treatment of CLI in patients with no revascularization options. While the primary objective of the trial has been to assess safety in patients with CLI, additional efficacy measures have been monitored, including time to treatment failure (where failure is defined as major amputation, doubling of wound size or new gangrene), amputation rate, wound size and severity. Approximately 1 million people in the U.S. suffer from CLI.

"I am very pleased that Dr. Powell will present these encouraging interim results at SVS," said Tim Mayleben, CEO and president at Aastrom. "Critical limb ischemia can be a deadly serious disease with very few treatment options. Aside from the amputation risk these patients face, more than 20% of CLI patients will die within 12 months of disease onset. Given the seriousness of the condition and the lack of treatment options for many patients, we are grateful to Dr. Powell and our other principal investigators for their work on this study. We are all eager to begin planning the Phase 3 program."

In February Aastrom reported highlights from a planned analysis of RESTORE-CLI interim data. The final patient treatment in this trial occurred in March.

About Aastrom Biosciences

Aastrom Biosciences is developing autologous cellular therapies for use in the treatment of severe cardiovascular diseases. The company's proprietary cell-processing technology enables the production of cellular therapies using a patient's own bone marrow that can be delivered directly to damaged tissues. Aastrom has advanced this technology into late-stage clinical development and is conducting two Phase 2 clinical trials to treat dilated cardiomyopathy and a Phase 2b clinical trial to treat critical limb ischemia. For more information, please visit Aastrom's website at www.aastrom.com.

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This document contains forward-looking statements, including without limitation, statements concerning clinical trial plans and expectations, industry presentations on trial results, clinical activity timing, intended product development and commercialization objectives, disease treatment and progression and expected timing of collecting and analyzing treatment data, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. These forward looking statements reflect management's current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

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