Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
Status:
Terminated
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
Summary
Fracture healing is a complex physiological process caused by interaction of cellular
elements, cytokines and signaling proteins, which results in the formation of new bone
(Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other
factors, 10% of all fractures will eventually fail to unite.
Non-union fractures are defined as fractures that are at least six to nine months old and in
which there have been no signs of healing for the last three months. Various causes have been
evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including
poor fracture stabilization, local infection and failure of the osteoblastic cells to
multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions,
is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and
external fixation devices (Kanakaris et al., 2007). This procedure produces good results but
requires an invasive surgery of several hours under general anesthesia and a few days of
hospitalization. Because of this, major complications have been reported in up to 20-30% of
patients (Pieske et al., 2009, Zimmerman et al., 2009).
This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary
population of autologous osteoblastic cells, in the treatment of hypotrophic non-union
fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority
design.