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

September 22, 2009 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Suspended

Conditions

Tibia or Femur Pseudo-arthrosis

Intervention / Treatment

Procedure: Chirurgical procedure

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- contra indications for chirurgical intervention or bone graft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate osseous setting at 3-months follow-up and compare our results with past studies Time Frame: at 3-months follow-up	at 3-months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Feasibility and tolerance of this therapeutic strategy Time Frame: at 3-months follow-up	at 3-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Marc Berger, Dr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria