Back to resultsOsseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Primary Purpose
Tibia or Femur Pseudo-arthrosis
Status
Suspended
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chirurgical procedure
Sponsored by
About this trial
This is an interventional treatment trial for Tibia or Femur Pseudo-arthrosis focused on measuring pseudo-arthrosis, osseous matrix, cell therapy
Eligibility Criteria
Inclusion Criteria:
- tibia or femur pseudo-arthrosis,
- patient who needs bone graft
Exclusion Criteria:
- - contra indications for chirurgical intervention or bone graft
Sites / Locations
Outcomes
Primary Outcome Measures
Evaluate osseous setting at 3-months follow-up and compare our results with past studies
Secondary Outcome Measures
Feasibility and tolerance of this therapeutic strategy
Full Information
NCT ID
NCT00557635
First Posted
November 12, 2007
Last Updated
September 22, 2009
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT00557635
Brief Title
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Official Title
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Suspended
Why Stopped
no recruited patients
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia or Femur Pseudo-arthrosis
Keywords
pseudo-arthrosis, osseous matrix, cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Chirurgical procedure
Intervention Description
Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
Primary Outcome Measure Information:
Title
Evaluate osseous setting at 3-months follow-up and compare our results with past studies
Time Frame
at 3-months follow-up
Secondary Outcome Measure Information:
Title
Feasibility and tolerance of this therapeutic strategy
Time Frame
at 3-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tibia or femur pseudo-arthrosis,
patient who needs bone graft
Exclusion Criteria:
- contra indications for chirurgical intervention or bone graft
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Berger, Dr
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
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