Status:
COMPLETED
Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
European Commission
Conditions:
Delayed Union After Fracture of Humerus, Tibial or Femur
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers a...
Detailed Description
Tissue engineering combines bone marrow cells or mesenchymal stem cells (MSCs), synthetic scaffolds and molecular signals (growth or differentiating factors) in order to form hybrids constructs. For b...
Eligibility Criteria
Inclusion
- Age 18 to 65, both sexes
- Traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphyseal-diaphyseal 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
Exclusion
- 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
- Acute persistent chronic bacterial infections such as brucellosis, typhus, leprosy, relapsing fever, melioidosis and tularemia
- Visceral injuries of diseases interfering with callus formation (cranioencephalic 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)
- History of neoplasia or current neoplasia in any organ
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01842477
Start Date
May 1 2013
End Date
February 5 2016
Last Update
January 30 2025
Active Locations (5)
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1
Depatment of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, France, 94000
2
Department of Orthopaedic Surgery, CHRU Tours
Tours, France, 37044
3
Department of Orthopaedic Trauma, University of Ulm
Ulm, Germany, 89081
4
Istituto Ortopedico Rizzoli, Bologna
Bologna, Italy, 40136