Status:
UNKNOWN
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Non Union/Delayed Fractures
Eligibility:
All Genders
18-65 years
Phase:
NA
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 fractu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01435434
Last Update
March 4 2014
Active Locations (1)
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1
Jerusalem, Israel