Aastrom Biosciences, Inc. has announced that the first two patients have been treated in a pivotal clinical trial utilizing the Company's Tissue Repair Cells (TRCs) for the treatment of osteonecrosis of the femoral head.
The trial sponsored by Aastrom is being conducted at Centro Medico Teknon located in Barcelona, Spain. Aastrom initiated patient enrollment and treatment after receiving written approval from the Spanish Drug Agency (AEMPS) and Teknon's Ethics Committee for the Company's Investigational Medicinal Product Dossier (IMPD).
"The initiation of this osteonecrosis clinical trial in Spain is an integral step for our overall bone regeneration program," said George Dunbar, Chief Executive Officer and President of Aastrom.
"If successful, the patient data from this pivotal trial will support future registration applications submitted to the regulatory authorities in the EU, as well as to the FDA in the U.S."
"The experience we acquired using the TRC cell product in prior studies of atrophic non-union long bone fractures gave us the confidence to apply the TRC technology to patients with osteonecrosis. We hope to demonstrate significant efficacy over existing therapies," said Dr. Lluís Orozco, Scientific Director, Orthopedics, of Institut de Terapia Regenerativa Tisular.
The tissues involved in the osteonecrosis disease process include bone, bone marrow and blood vessels (vascular), complicating the development of treatments in the past.
In 2006, Aastrom's proprietary TRCs received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of osteonecrosis of the femoral head. Aastrom is preparing a protocol for a U.S. pivotal osteonecrosis clinical trial with the FDA.