EUCTR2011-005441-13-DE
Active, not recruiting
Phase 1
Evaluation of efficacy and safety of autologous MSCs combined to biomaterials to enhance bone healing in patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics. - REBORNE - ORthoCT1
ConditionsClosed 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 disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture.
- Sponsor
- INSERM
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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