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
Conditions
Interventions
Product Name: Cultured Autologous Mesenchymal Stem Cells mixed with the biomaterial MBCP+ TM
Pharmaceutical Form: Implant
INN or Proposed INN: Autologous Mesenchymal St
Sponsors
INSERM
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of 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 with MSC in the FU of patients. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - number of patients with proven bone healing, in proportion of the recruited , treated patients. - clinical consolidation - no reoperation done or scheduled - changes in serum levels of bone turnover markers ; Timepoint(s) of evaluation of this end point: - number of patients with proven bone healing at 6 weeks, 12 weeks, and 247 weeks - clinical consolidation at weeks 6, 12 24 - no reoperation done or scheduled at 24 weeks | — |
Countries
Germany, Italy, Spain
Contacts
Public ContactEnrique Gómez Barrena
Hospital Universitario La Paz-Universidad Autónoma de Madrid
Outcome results
None listed