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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Tibia or Femur Pseudo-arthrosis
 Procedure: Chirurgical procedure
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Feasibility and tolerance of this therapeutic strategy [ Time Frame: at 3-months follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Chirurgical procedure
    Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - contra indications for chirurgical intervention or bone graft
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557635

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Marc Berger, Dr
  More Information

No publications provided

Responsible Party: Marc Berger, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00557635     History of Changes
Other Study ID Numbers: CHU-0026
Study First Received: November 12, 2007
Last Updated: September 22, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
pseudo-arthrosis, osseous matrix, cell therapy

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Pseudarthrosis
Musculoskeletal Diseases
Arthritis
 Rheumatic Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013