Scimitar Equity Blog

The final patient has been treated 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.  TRC-based cellular therapies are produced from a small sample of bone marrow taken from a patient. ASTM’s TRC technology greatly expands the cell populations for direct delivery to the damaged tissues of the same patient.

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 were also 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.

• ASTM is now well positioned to report 6 month interim results for all enrolled patients later this year and initiate planning for a pivotal Phase 3 vascular trial,
• Patients continue to be evaluated at both 6 and 12 months following treatment,
• ASTM plans to initiate phase 3 planning discussions with the FDA,
• 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.