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

Tibial Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250302
• Other study ID #: AMSC-01-HMO-CTIL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 6, 2005
• Last updated: April 27, 2011
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Procedure:
• autologous mesenchymal stem cells implantation

Locations

Country	Name	City	State
Israel	Hadassah Medical Organizaton	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Teva Pharmaceutical Industries

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Number of patients reaching clinical union of fracture