Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of
the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.
Core decompression is currently the treatment of choice for early stage osteonecrosis of the
femoral head. This method consists in decompressing the rigid intra-osseous chamber to
promote revascularization, thus halting progression of the disease and stimulating repair.
Still this treatment remains highly controversial, since the success rates of the first
studies have not been repeated.
The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.
Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,
microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells
Three studies have indicated the potential clinical benefits of cell-based approaches for the
treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).
This is on the basis of these observations that a proprietary population of autologous
osteoblastic cells (PREOB®) has been developed.
This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment
of early stage osteonecrosis of the femoral head. The primary goal of this study was to
investigate the safety and efficacy of the implantation of the investigational product PREOB®
(human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow
concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a
follow-up period of up to 5 years.