Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
NCT ID: NCT01435434
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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sepax, ignite, fracture healing
the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT
the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.
Interventions
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the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.
Eligibility Criteria
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Inclusion Criteria
2. Males- not involved in active military duty.
3. 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.
4. 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
2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
3. Pathological Fractures.
4. Prior Fracture or Prior operation in the current fracture
18 Years
65 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Locations
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Jerusalem, , Israel
Countries
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Central Contacts
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Other Identifiers
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lieb001-CTIL-HMO
Identifier Type: -
Identifier Source: org_study_id
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