Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

Hadassah Medical Organization0 sitesSeptember 16, 2011

ConditionsNon Union/Delayed Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non Union/Delayed Fractures
Sponsor: Hadassah Medical Organization
Primary Endpoint: clinical and radiological bony union at 3 months and 6 months.
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .

Registry

clinicaltrials.gov

Start Date

September 16, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hadassah Medical Organization

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ages: 18 to 65
•Males- not involved in active military duty.
•Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
•Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.

Exclusion Criteria

•Active systemic or local infection.
•History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
•Pathological Fractures.
•Prior Fracture or Prior operation in the current fracture