Aastrom begins phase 1, 2 trial of Tissue Repair Cell's ability to form new bone tissue in spine

By E. Janene Geiss

Philadelphia, Nov. 30 - Aastrom Biosciences, Inc. said Wednesday that it will begin a human clinical trial for the evaluation of the company's Tissue Repair Cell product to form new bone tissue in the spine.

The phase 1, 2 trial will be conducted under an Investigational New Drug Application approved by the U.S. Food and Drug Administration and initially conducted at a single clinical center, the William Beaumont Hospital in Royal Oak, Mich., according to a company news release.

Aastrom's Tissue Repair Cell, a proprietary bone marrow-derived adult stem cell product, will be used in posterior-lateral lumbar spinal fusions for treatment of degenerative spondylolisthesis.

This is the company's second FDA-approved, human clinical trial for local bone regeneration using Tissue Repair Cells.

Spine fusion is a procedure in which new bone tissue is induced to fuse two or more vertebrae together to treat conditions such as fractures of the vertebrae or ruptured or lost disks.

Current therapy uses surgically transplanted bone tissue, as well as other artificial bone materials and bone growth factors to induce the growth of new bone tissue.

Aastrom said it proposes to use its Tissue Repair Cells in combination with a carrier matrix to induce sufficient bone growth to fuse or merge two vertebrae in the lower back and potentially eliminate the requirement for other more invasive or less effective approaches.

By stabilizing the spine, officials said, this procedure reduces debilitating back pain and helps a patient regain more normal use of their legs.

The primary purpose of the approved clinical trial is to confirm that Aastrom's product, when used as a bone graft, is safe for use in posterior-lateral lumbar spinal fusion surgery and is able to generate new bone at the fusion site based on defined radiographic and clinical data, officials said.

"With clinical studies already using [Tissue Repair Cells] to generate jaw bone and to repair severe bone fractures, we are very enthusiastic about this new FDA- approved study to extend the evaluation of TRCs to a third type of bone tissue," Aastrom chief executive officer and chairman R. Douglas Armstrong said in the release.

Aastrom's autologous Tissue Repair Cell product is already being evaluated to treat severe long bone fractures in an FDA-approved, multi-center clinical trial in the United States, and the company has reported positive bone growth results from its fracture trial in Spain.

Tissue Repair Cells also are being evaluated for their ability to generate jaw bone in a single center trial in Spain, to enable the placement of dental implants, officials said. And Aastrom recently announced that the first clinical trial utilizing Tissue Repair Cells to treat limb ischemia in diabetic patients was initiated at a center in Bad Oeynhausen, Germany.

Aastrom is an Ann Arbor, Mich., biotechnology company developing patient-specific products for the repair or regeneration of human tissues, using its proprietary adult stem cell technology.

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