Clinical trial on the application of cells for tissue repair (Tissue Repair Cell, TRC*) in osteonecrosis therapy of the femoral head
Num Eudra CT: 2006-001286-42
Clinical trial with pilot characteristics to determine if an autologous TRC graft safely eliminates or delays the progression of osteonecrosis once the decompression surgery of the femoral head centre is performed.
Phase II, open-label, prospective and unicentric clinical trial. 9 patients with femoral osteonecrosis were included.
The intervention consisted of the classic decompression of necrosis, reaching the necrotic head through the neck of the femur, and the application of the graft composed by mesenchymal progenitor cells and βtricalcium-phosphate granules compacted with an autologous fibrin clot.
The hypothesis states that providing a superior quantity and quality of progenitor cell to other treatments favours revascularization and tissue regeneration.
There have been no significant adverse effects related to cell treatment.
Radiographic studies showed stabilization of the degenerative process.
After 5 years of treatment, in only 2 out of 9 patients the deterioration progressed to the point of needing a prosthesis implantation.
Development phase: IIa
No. Eudra-CT: 2006-001286-42
Sponsor: Aastrom Biosciencies SL. Barcelona-España
CEIC: Centro Médico Teknon
Control: Spanish Medicine Agency (AEMPS)
CRO: TFS, QUINTILES
Investigators: L Orozco, R Soler Rich, C Solano, J Pous
Cellular Production Unit: Banc de Sang i Teixits (BST)
Scientific collaboration: E Boada
Participating entities: Centro Médico Teknon
Funding: Aastrom Biosciencies Inc. (Michigan, EUA)
*TRC: Tissue Repair Cells. Autologous Bone Marrow Progenitor Cells expanded with the Aastrom Replicell™ system