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

Tibia or Femur Pseudo-arthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00557635
• Other study ID #: CHU-0026
• Status: Suspended
• Phase: Phase 2
• First received: November 12, 2007
• Last updated: September 22, 2009
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2009
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• tibia or femur pseudo-arthrosis,

• patient who needs bone graft

Exclusion Criteria:

• - contra indications for chirurgical intervention or bone graft

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pseudarthrosis
• Tibia or Femur Pseudo-arthrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate osseous setting at 3-months follow-up and compare our results with past studies		at 3-months follow-up	Yes
Secondary	Feasibility and tolerance of this therapeutic strategy		at 3-months follow-up	Yes