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Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00250302
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : April 28, 2011
Sponsor:
Collaborator:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by:
Hadassah Medical Organization

Study Description
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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 treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.

Condition or disease Intervention/treatment Phase
Tibial Fracture Procedure: autologous mesenchymal stem cells implantation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety
  2. Number of patients reaching clinical union of fracture

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250302


Locations
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Israel
Hadassah Medical Organizaton
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Principal Investigator: Meir Liebergall, Prof. Hadassah Medical Organization
Study Director: Rami Mosheiff, Prof. Hadassah Medical Organization
Study Chair: Dan Gazit, Prof. Hebrew University
More Information
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ClinicalTrials.gov Identifier: NCT00250302    
Other Study ID Numbers: AMSC-01-HMO-CTIL
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: October 2010
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries