Status:
WITHDRAWN
Treatment of Atrophic Nonunion Fractures by Autologous Mesenchymal Stem Cell Percutaneous Grafting
Lead Sponsor:
University of Liege
Conditions:
Nonunion Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bone fractures heal most of the time particularly well and without complications. The solidification takes rarely more than two to three months. The wound healing depends greatly on a good blood suppl...
Eligibility Criteria
Inclusion
- Male or female; female patients must use a reliable contraception method
- Age ≥ 18 years
- Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
- No sepsis
- Good skin covering
- Be able and willing to participate in the study
- Written informed consent
Exclusion
- Evidence of malignancy (except non-melanoma skin cancer) in the past five years
- Pregnancy or breastfeeding
- Patient positive by serology or PCR for HIV, hepatitis B or C infection
- Insufficient reduction of the fracture with displaced fragments
- Evidence of local sepsis by clinical signs, biological parameters (CRP) and/or positive isotopic scan using Indium-labelled leucocytes
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01429012
Start Date
November 1 2012
End Date
November 1 2016
Last Update
May 12 2021
Active Locations (1)
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1
Liège University Hospital
Liège, Belgium, 4000