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

NCT ID: NCT00557635

Last Updated: 2009-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Tibia or Femur Pseudo-arthrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Chirurgical procedure

Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \- contra indications for chirurgical intervention or bone graft
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Marc Berger, Dr

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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CHU-0026

Identifier Type: -

Identifier Source: org_study_id

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