Ann Arbor, MI-based startup Aastrom (NASDAQ: ASTM) recently announced it has reached an agreement with the FDA on the terms of a Special Protocol Assessment for the design of its Phase III clinical study of ixmyelocel-T, the company’s multicell therapy for patients with critical limb ischemia (CLI) who have no other treatment options.
CLI is a severe form of cardiovascular disease in the legs, known as peripheral artery disease, in which blood vessels get so clogged up that doctors are forced to amputate. Aastrom’s approach involves withdrawing a patient’s bone marrow cells, incubating them in a proprietary process at its Ann Arbor facility, and spurring growth of adult stem cells and progenitor cells that promote healing. Those revved up cells get re-infused into the patient, where they are supposed to foster the growth of new blood vessels to improve circulation.
“The FDA encouraged us to pursue this [Special Protocol Assessment] process since there aren’t a lot of new therapies for iscemia,” said Aastrom CEO Tim Mayleben. “The Special Protocol Assessment provides Aastrom and our investors with more confidence that we’re running a well-designed trial. It’s not a guarantee that they’ll approve our therapy by any means, but if we follow the protocol plan and deliver good results, there’s a high chance of FDA approval.”
Mayleben said one thing that attracted him to Aastrom’s method of therapy is that the patients’ own cells are used, eliminating the ethical controversy that sometimes hampers other stem-cell studies.
“More importantly,” Mayleben said, “there are fewer safety issues.”
Mayleben estimates the trial will take two and a half years—18 months to recruit patients, and 12 months to follow up. He said Aastrom is one of the few biotech companies in the world that has come this far, to the third and final stage of clinical trials normally required for FDA approval.
“It’s an exciting place to be from a healthcare standpoint,” Mayleben said.
