Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Phase 2
Suspended
- Conditions
- Tibia or Femur Pseudo-arthrosis
- Registration Number
- NCT00557635
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.
- Detailed Description
All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one.
Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- tibia or femur pseudo-arthrosis,
- patient who needs bone graft
Exclusion Criteria
-
- contra indications for chirurgical intervention or bone graft
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate osseous setting at 3-months follow-up and compare our results with past studies at 3-months follow-up
- Secondary Outcome Measures
Name Time Method Feasibility and tolerance of this therapeutic strategy at 3-months follow-up