Aastrom Gets FDA Fast Track Status, Gears Up for Pivotal Study of Cell Therapy

10/18/10Follow @xconomy

Aastrom Biosciences is gearing up for a definitive test of a first-of-its-kind regenerative medicine that uses adult stem cells. The Ann Arbor, MI-based biotech company said today it has gotten the FDA’s “fast track” designation for its pivotal clinical trial plan of a treatment that it hopes will help people with severe cardiovascular disease to avoid limb amputations.

The FDA designation itself doesn’t mean a whole lot—it really just enables Aastrom (NASDAQ: ASTM) to potentially get a faster-than-usual six-month regulatory review which is sometimes granted to life-saving therapies. The designation also means that Aastrom will be able to file its application for FDA approval as data becomes available in bits and pieces, rather than wait to bundle everything together at the end for the regulatory review, which can take more time.

The true test for Aastrom will begin early next year, when it plans to start a pivotal clinical trial of its treatment for critical limb ischemia (CLI). This 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 choose to amputate. Aastrom’s idea is withdraw a patient’s bone marrow cells, incubate them in a proprietary process at its Ann Arbor facility, and spur growth of adult stem cells and progenitor cells that promote healing. Those revved up cells get re-infused into the patient, and they are supposed to foster growth of new blood vessels to improve circulation.

If this can be proven in the pivotal clinical trial, it could be Aastrom’s first marketed cell therapy, and could offer a less invasive treatment option for doctors who perform 160,000 limb amputations a year.

Aastrom has already conducted a clinical trial of 90 patients. A preliminary analysis showed that the company’s cell therapy was able to delay some of the most severe complications of the disease (amputations, large wounds, and gangrene). The company hasn’t yet presented the full set of data, and hasn’t yet talked publicly in detail about the design of its pivotal clinical trial. If that study is set up in a way to generate a convincing answer on whether the Aastrom therapy works, then this story will start to get more and more interesting for scientists and investors.

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