Aastrom gets orphan drug designation for proprietary bone marrow cells

By Elaine Rigoli

Tampa, Fla., March 23 - Aastrom Biosciences, Inc. announced Thursday that the company's proprietary tissue repair cells (TRCs) received an orphan drug designation from the Food and Drug Administration for use in the treatment of osteonecrosis (avascular necrosis).

Osteonecrosis is a painful medical condition where the tissue inside a bone is dying and unable to regenerate itself through natural processes.

Some 90% of the patients afflicted by this disease have osteonecrosis at the hip, or more specifically the femoral head - the ball at the top of the femur bone that rotates inside the hip socket, according to a news release.

This disease usually attacks young male adults, and left untreated the femoral head eventually collapses, leading to the requirement of a total hip joint replacement, the release said.

The tissues destroyed in the osteonecrosis disease process include bone, bone marrow and vascular.

Aastrom's TRCs, a mixture of stem, stromal and progenitor cells derived from a small sample of the patient's own bone marrow, have been used in clinical trials to regenerate all three of these tissues.

With this capability, TRCs may offer a novel means to restore healthy tissue at osteonecrotic sites, the release said.

Aastrom is preparing a clinical trial protocol to evaluate TRCs in the treatment of osteonecrosis at the hip.

"We are pleased to receive an orphan drug designation for our TRC cell product as a new treatment option for patients with such a significantly debilitating disease. This progress is a part of our strategic plan for the development of a new concept in products for use in complex orthopedic indications," chairman and chief executive officer R. Douglas Armstrong said in the release.

Ann Arbor, Mich.-based Aastrom develops products for the repair or regeneration of multiple human tissues.

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