Back to resultsAutologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Primary Purpose
Tibial Fracture
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
autologous mesenchymal stem cells implantation
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fracture
Eligibility 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.
Sites / Locations
- Hadassah Medical Organizaton
Outcomes
Primary Outcome Measures
Safety
Number of patients reaching clinical union of fracture
Secondary Outcome Measures
Full Information
NCT ID
NCT00250302
First Posted
November 6, 2005
Last Updated
April 27, 2011
Sponsor
Hadassah Medical Organization
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00250302
Brief Title
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Official Title
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
autologous mesenchymal stem cells implantation
Primary Outcome Measure Information:
Title
Safety
Title
Number of patients reaching clinical union of fracture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Liebergall, Prof.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rami Mosheiff, Prof.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dan Gazit, Prof.
Organizational Affiliation
Hebrew University
Official's Role
Study Chair
Facility Information:
Facility Name
Hadassah Medical Organizaton
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
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