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
Objectives
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.
Methodology
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.
Results
Safety
There have been no significant adverse effects related to cell treatment.
Efficacy
Radiographic studies showed stabilization of the degenerative process.
Conclusions
After 5 years of treatment, in only 2 out of 9 patients the deterioration progressed to the point of needing a prosthesis implantation.
STUDY DESCRIPTION
Unicentric study
Development phase: IIa
Status: completed
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