Status:
COMPLETED
Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell
Lead Sponsor:
Royan Institute
Conditions:
Nonunion Fractures
Eligibility:
All Genders
12-75 years
Phase:
PHASE1
Brief Summary
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progre...
Detailed Description
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progre...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Both genders are eligible
- Nonunion or delayed union diagnosed with X-Ray examination.
- More than 4 cm distance to joint
- Provided written informed consent
- Exclusion criteria:
- Multiple major fracture or untreated major fracture
- Infected fracture
- HIV, hepatitis B or hepatitis C infection at the time of screening
- Pregnant or lactating women
- Diagnosis of cancer
- Active treatment with immunosuppressive drugs or anticoagulant agent
- Known allergic reaction to components of study treatment and/or study injection procedure
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01206179
Start Date
March 1 2009
End Date
May 1 2011
Last Update
December 14 2011
Active Locations (1)
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1
Royan Institute
Tehran, Iran