Osseous Setting Improvement With Co-implantation of Osseo... | NCT00557635

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

NCT00557635

Sponsor

University Hospital, Clermont-Ferrand

Status

Suspended

Last Update Posted

Sep 23, 2009Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Tibia or Femur Pseudo-arthrosis

Interventions

Chirurgical procedure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no recruited patients

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 12, 2007

First Submission Date that Met QC Criteria

Nov 12, 2007

First Posted Date

Nov 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2009

Last Update Posted Date

Sep 23, 2009Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chirurgical procedure	Procedure	Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- contra indications for chirurgical intervention or bone graft

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided