Aastrom’s tissue repair cell (TRC) product, 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 TRCs.
The primary purpose of the trial is to confirm that Aastrom’s TRC 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.
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 proposes to use its TRCs 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, this procedure reduces debilitating back pain, and helps a patient regain more normal use of their legs.
“With clinical studies already using TRCs 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,” noted Dr Douglas Armstrong, CEO and chairman of Aastrom. “We are also gratified that this study is being conducted by an outstanding clinical team led by Dr Herkowitz at Beaumont Hospital.”