Development of a therapy to treat patients with delayed consolidation after fracture of long bones

• Conditions: Closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture; MedDRA version: 14.1Level: PTClassification code 10017081Term: Fracture delayed unionSystem 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-IT
• Lead Sponsor: INSERM - Institut National de la Sant? et de la Recherche m?dicale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 nonunion
· 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

· Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control · Participation in another therapeutic trial in the previous 3 months · Delayed union or non-union related to iatrogeny · Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc) · Vascular or neural injury · Other fractures causing interference with weight bearing · Infection: skin, soft-tissue, bone or any remote infection (dental, pulmonary, gynecological) · Visceral injuries of diseases interfering with callus formation (craneoencephalic trauma, etc.) · History of bone harvesting on iliac crest contraindicating bone-marrow aspiration · Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion · History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR) · Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility. · Impossibility to meet at the appointments for the follow up · Insulin dependent diabetes · Obesity (BMI > 30) · Autoimmune inflammatory disease · Current treatment by biphosphonate or stopped in the three months prior to study inclusion.

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;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;Primary end point(s): -Local complication rate regarding the non-union treatment in the FU -Local and general complication rate regarding potential effects of introducing the biomaterial with MSC in the FU of patients.;Timepoint(s) of evaluation of this end point: Complication rates at weeks : 6, 12, 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of patients with proven bone healing at 6 weeks, 12 weeks, and 24 weeks - Clinical consolidation at weeks 6, 12, 24. - No reoperation done or scheduled at 24 weeks;Timepoint(s) of evaluation of this end point: - number of patients with proven bone healing at 6 weeks, 12 weeks, and 24 weeks - clinical consolidation at weeks 6, 12, 24 - no reoperation done or scheduled at 24 weeks