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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 Pharmaceutical Industries
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE November 6, 2005
First Posted Date  ICMJE November 8, 2005
Last Update Posted Date April 28, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2005)
  • Safety
  • Number of patients reaching clinical union of fracture
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00250302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Official Title  ICMJE Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tibial Fracture
Intervention  ICMJE Procedure: autologous mesenchymal stem cells implantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 6, 2005)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00250302
Other Study ID Numbers  ICMJE AMSC-01-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Teva Pharmaceutical Industries
Investigators  ICMJE
Principal Investigator: Meir Liebergall, Prof. Hadassah Medical Organization
Study Director: Rami Mosheiff, Prof. Hadassah Medical Organization
Study Chair: Dan Gazit, Prof. Hebrew University
PRS Account Hadassah Medical Organization
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP