Development of tissue engineering therapy to treat patients with delayed consolidation after fracture of long bones.

Phase 1

• Conditions: Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture.; MedDRA version: 14.1 Level: PT Classification code 10017081 Term: Fracture delayed union System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2011-005441-13-DE
• Lead Sponsor: INSERM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- age 18 to 65 both sexes
- traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture status delayed union or non union
- at least 3 months from acute fracture
- able to provide informed consent, and signed informed consent
- patients (by themselves) should have medical health care coverage to be included in a research study
- able to understand and accept the study constraints
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
- participation in another therapeutic trial previous 3 months
- delayed union or non-union related to iatrogeny
- segmental bone loss requiring therapy
- vascular or neural injury
- impossibility to meet appointments for the follow up
- other fractures causing interference with weight bearing
- infection
viceral injuries of diseases interfering with callus formation
- history of bone harvesting on iliac crest contraindicating bone-marriw aspiration
- corticoid or immunosuppressive therapy more than one week in the 3 mionths prior ti study inclusion
- history of prior concurrent diagnosis of HIV, Hepatitis B or C infection
- insulin dependent diabetes
- obesity
- autoimmune inflammatory disease
- current treatment by bisphonate or stopped in the 3 months prior to stydy inclusion
- subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission a health facility.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of apposition of biomaterial with autologous MSCs at the fracture site;<br> Primary end point(s): - local complication rate regarding the non-union treatment in the FU<br> - local and general complication rate regarding potential effects of introducing the biomaterial with with MSC in the FU of patients.<br> ;Secondary Objective: To obtain consolidation, without increasing the complication rate, of diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus)status delayed union (after 3 months), treated by standard care procedures plus apposition of biomaterial with autologous MSCs at the fracture site.;Timepoint(s) of evaluation of this end point: complication rates at weeks : 6, 12, 24

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - number of patients with proven bone healing, in proportion of the recruited , treated patients.<br> - clinical consolidation<br> - no reoperation done or scheduled<br> - changes in serum levels of bone turnover markers<br> ;<br> Timepoint(s) of evaluation of this end point: - number of patients with proven bone healing at 6 weeks, 12 weeks, and 247 weeks<br> - clinical consolidation at weeks 6, 12 24<br> - no reoperation done or scheduled at 24 weeks<br>