HONG KONG/LEIPZIG, Germany: At a meeting on regenerative medicine and stem cell research in China, clinicians from Spain presented what could be a breakthrough in the treatment of craniofacial defects. With the help of Bone Repair Cells (BRCs) developed by the US company Aastrom Biosciences Inc. , patients experienced new bone formation and nerve recovery in cases of severe mandibular osteoradionecrosis and osteomyelitis.

Bone Repair Cells are derived from a small sample of the patient’s bone marrow, which is processed using Aastrom’s proprietary Tissue Repair Cell (TRC) technology to generate larger numbers of stem and early progenitor cells with enhanced therapeutic potential.

“The outcome of these treatments with BRCs has been very satisfactory. We observed early bone formation in the afflicted areas that eventually resulted in complete healing,” said Dr Jose Mendonca, Director of the Head and Neck Surgery Unit of Hospital POLUSA in Lugo in Spain and previously a Clinical and Research Fellow in Oral and Maxillofacial Surgery at the UCLA School of Dentistry, “Unexpected therapeutic results from treatment with BRCs include peripheral nerve regeneration or repair, new skin formation and proliferation in blood vessels in ischemic areas. The results open a promising pathway for the treatment of some patients where conventional therapies fail or do not exist.”

Ethical approval for compassionate use of TRC-based products was granted by the Spanish Ministry of Health.

In May 2008, Aastrom announced the re-prioritisation of its clinical development programmes to focus primarily on cardiovascular applications, thus discontinuing further patient enrolment in the US Phase III ON-CORE bone regeneration clinical trial. The company does not anticipate new clinical bone activity or reactivating the Phase III ON-CORE trial at the present time but will continue to treat patients on a compassionate-use basis in Spain.

“Our bone programme remains open for partnering. Encouraging compassionate-use treatments such as those noted by Dr Mendonca strengthen our bone programme portfolio, especially in the EU,” said Dr Sheldon A. Schaffer, Aastrom’s Vice-President of Corporate Development and Intellectual Property.