Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

This study has suspended participant recruitment.
(no recruited patients)
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00557635
First received: November 12, 2007
Last updated: September 22, 2009
Last verified: September 2009

November 12, 2007
September 22, 2009
January 2008
November 2011   (final data collection date for primary outcome measure)
Evaluate osseous setting at 3-months follow-up and compare our results with past studies [ Time Frame: at 3-months follow-up ] [ Designated as safety issue: Yes ]
Evaluate osseous setting at 3-months follow-up and compare our results with past studies [ Time Frame: at 3-months follow-up ]
Complete list of historical versions of study NCT00557635 on ClinicalTrials.gov Archive Site
Feasibility and tolerance of this therapeutic strategy [ Time Frame: at 3-months follow-up ] [ Designated as safety issue: Yes ]
Feasibility and tolerance of this therapeutic strategy [ Time Frame: at 3-months follow-up ]
Not Provided
Not Provided
 
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tibia or Femur Pseudo-arthrosis
Procedure: Chirurgical procedure
Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • tibia or femur pseudo-arthrosis,
  • patient who needs bone graft

Exclusion Criteria:

  • - contra indications for chirurgical intervention or bone graft
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00557635
CHU-0026
Not Provided
Marc Berger, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Marc Berger, Dr
University Hospital, Clermont-Ferrand
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP