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

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.

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Key information

Conditions

Tibial Fracture Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hadassah Medical Organizaton

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

autologous mesenchymal stem cells implantation

Procedure

Primary outcomes

Safety
Number of patients reaching clinical union of fracture

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 8, 2005
Registry last updated: Apr 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed