Aastrom study shows its Tissue Repair Cells help bone growth for dental implants

By Ted A. Knutson

Washington, Dec. 21 - Aastrom Biosciences, Inc. interim results from its feasibility clinical trial announced Wednesday evaluating Aastrom's Tissue Repair Cells for maxillary (upper jaw) bone reconstruction to support placement of dental implants showed clinical safety. The results also showed that Tissue Repair Cells treatment sites all exhibited bone growth that was statistically significant and had the desired initial integration with preexisting bone.

The study was conducted with the Teknon Hospital Maxillofacial Clinic in Barcelona, Spain.

The goal of this clinical trial was to evaluate the safety and ability of Tissue Repair Cells - a proprietary autologous bone marrow-derived stem cell product - to increase bone height in the posterior maxilla (upper jaw) of five patients, who had severe bone loss in the region and minimal residual bone remaining. The patients were judged to have a poor prognosis with previously lost teeth due to periodontal disease and tooth decay, and additional risk factors that are known to compromise bone regeneration and preservation. These risk factors included many years of smoking, osteoporosis and advanced age.

The intent of the therapy was to help rebuild healthy bone so that there was enough bone to accommodate the length of the dental implants. A standard bone graft technique was used as an internal concurrent control on the other side of the maxilla.

All of the primary outcomes described by the trial protocol were successfully achieved, the company said.

Results showed that all five patients treated locally with Aastrom's Tissue Repair Cells exhibited a statistically significant increase in bone height at the three-month evaluation point and the cell graft had started to integrate with the surrounding preexisting bone of the upper jaw by four months, with no cell-related adverse events.

The results were obtained from radiographs and from biopsies taken at the interface of the original bone and the new tissue. All patients went on to receive three to four dental implants on each side of their maxilla.

"Edentulous patients who have lost this much jaw bone can be very difficult to treat," said Dr. Federico Hernandez-Alfaro, principal investigator for the trial, in a news release. "[Tissue Repair Cells] may offer an improved treatment over existing therapies because they appear to naturally accelerate integration of new bone with the existing bone in the patient, and increase bone mass for implant placement."

Aastrom is implementing a "proof of concept" clinical plan to evaluate the ability of Tissue Repair Cells to generate three different types of bone: long bone, jawbone and spine. Trials involving multiple centers in the United States and Europe are evaluating Tissue Repair Cells in the repair of severe non-union fractures, where preliminary results have demonstrated both safety and bone growth success, the company said.

A trial for the regeneration of spine bone (vertebral fusion) has begun in the United States. In addition, the company is now engaged in a human clinical trial in Germany evaluating the use of its Tissue Repair Cells to treat limb ischemia in diabetic patients through the regeneration of vascular tissue in extremities.

Ann Arbor, Mich.-based Aastrom Biosciences is developing patient-specific products for the repair or regeneration of human tissues, using the company's proprietary adult stem cell technology.

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