EUCTR2011-005441-13-IT
Active, not recruiting
Not Applicable
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 - OrthoCT 1
INSERM - Institut National de la Sant? et de la Recherche m?dicale0 sites30 target enrollmentDecember 19, 2012
ConditionsClosed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fractureMedDRA version: 14.1Level: PTClassification code 10017081Term: Fracture delayed unionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture
- Sponsor
- INSERM - Institut National de la Sant? et de la Recherche m?dicale
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 12 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 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
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.
Outcomes
Primary Outcomes
Not specified
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