Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Pharmaceutical Industries
Information provided by:
Hadassah Medical Organization

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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
Layout table for location information
Israel
Hadassah Medical Organizaton
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Teva Pharmaceutical Industries
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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:
Layout table for MeSH terms
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries