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

Hadassah Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Tibial Fracture

Treatments

Procedure: autologous mesenchymal stem cells implantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00250302

AMSC-01-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.