Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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)
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: November 12, 2007
Last updated: September 22, 2009
Last verified: September 2009
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:

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 ]

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

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00557635

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

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

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries processed this record on April 28, 2017