Back to resultsMononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
Primary Purpose
Non Union/Delayed Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.
Sponsored by
About this trial
This is an interventional treatment trial for Non Union/Delayed Fractures focused on measuring subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sepax, ignite, fracture healing
Arm Description
the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT
Outcomes
Primary Outcome Measures
clinical and radiological bony union at 3 months and 6 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT01435434
First Posted
September 4, 2011
Last Updated
March 3, 2014
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01435434
Brief Title
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Union/Delayed Fractures
Keywords
subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
sepax, ignite, fracture healing
Arm Type
Experimental
Arm Description
the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT
Intervention Type
Device
Intervention Name(s)
the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.
Primary Outcome Measure Information:
Title
clinical and radiological bony union at 3 months and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Facility Information:
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
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