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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00250302
First received: November 6, 2005
Last updated: April 27, 2011
Last verified: October 2010
  Purpose

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 Intervention Phase
Tibial Fracture
Procedure: autologous mesenchymal stem cells implantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Safety
  • Number of patients reaching clinical union of fracture

Estimated Enrollment: 24
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250302

Locations
Israel
Hadassah Medical Organizaton
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Teva Pharmaceutical Industries
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00250302     History of Changes
Other Study ID Numbers: AMSC-01-HMO-CTIL
Study First Received: November 6, 2005
Last Updated: April 27, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014