Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
|ClinicalTrials.gov Identifier: NCT00557635|
Recruitment Status : Suspended (no recruited patients)
First Posted : November 14, 2007
Last Update Posted : September 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Tibia or Femur Pseudo-arthrosis||Procedure: Chirurgical procedure||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||December 2011|
- Procedure: Chirurgical procedure
Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
- Evaluate osseous setting at 3-months follow-up and compare our results with past studies [ Time Frame: at 3-months follow-up ]
- Feasibility and tolerance of this therapeutic strategy [ Time Frame: at 3-months follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557635
|Principal Investigator:||Marc Berger, Dr|