Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Mar 26 2010

Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease. People with CLI face a high risk of amputation and, in some cases, death. Approximately 1 million people in the U.S. suffer from CLI, which results in more than 160,000 amputations each year.

Aastrom's RESTORE-CLI trial is the largest double-blind, randomized cell therapy study currently being conducted for CLI. The trial has enrolled a total of 86 patients at 18 sites in the United States. Patients in the treatment group received intramuscular injections of TRCs into the affected limb, while control patients received intramuscular injections with an electrolyte solution (without cells). Both groups also received appropriate standard of care for their condition. While the primary objective of this trial is to assess safety in patients with CLI, additional efficacy measures are also being 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. Ankle brachial pressure index, pain and quality of life are also being monitored. Patients are being evaluated at both six months and 12 months following treatment.

"We are pleased to announce this milestone in our vascular regeneration program," said Tim Mayleben, president and CEO of Aastrom. "With the treatment of the final patient in this trial, we are well-positioned to report six-month interim results for all enrolled patients later this year and  initiate planning for a pivotal Phase 3 vascular trial."

TRC-based cellular therapies are produced from a small sample of bone marrow taken from a patient. Aastrom's TRC technology greatly expands the cell populations for direct delivery to the damaged tissues of the same patient.