Aastrom Biosciences looks to begin Phase 3 trial of vascular-repair stem cells

Stem cell company Aastrom Biosciences plans to begin a Phase 3 clinical trial of its treatment for critical limb ischemia.

Critical limb ischemia results from a decreased blood supply, is often the endpoint of peripheral arterial disease and can lead to amputation.

Aastrom said it will proceed with the Phase 3 trial of its vascular repair cells after it reported positive safety results from a Phase 2b trial. In the phase 2b trial, patients were treated with Aastrom’s “experimental” therapy developed using their own bone marrow stem cells. The trial’s interim results show patients who received Aastrom’s treatment over time exhibited fewer “treatment failure” events such as amputations, or a doubling in wound size, according to a statement from the company.

The company is also in the midst of clinical trials of its cardiac regeneration therapy, which uses a patient’s own stem cells to repair and regenerate damaged heart tissue.

Last week Aastrom completed a a 1-for-8 reverse stock split that has so far achieved its desired effect of pushing the company’s share price above $1 so it can remain listed on the Nasdaq stock exchange. The company’s stock was trading at $1.46 late Wednesday morning.