Status:
COMPLETED
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Tibial Fracture
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to t...
Eligibility Criteria
Inclusion
- ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation.
Exclusion
- active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00250302
Start Date
April 1 2009
End Date
April 1 2011
Last Update
April 28 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hadassah Medical Organizaton
Jerusalem, Israel