Back to resultsMesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
Primary Purpose
Healing of Fracture
Status
Unknown status
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
stem cells + hydroxy apatite
autograft taken from iliac crest
Sponsored by
About this trial
This is an interventional treatment trial for Healing of Fracture focused on measuring nonunion, stem cells, autograft, hydroxyapatite
Eligibility Criteria
Inclusion Criteria:
- athropic nonunion fracture of the long bone
Exclusion Criteria:
- immunocompromise,
- active infection,
- pathological fracture,
- ongoing hormonal therapy
Sites / Locations
- RSCMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stem cells
autograft
Arm Description
stem cells + hydroxy apatite
Outcomes
Primary Outcome Measures
healing of fracture
radiological union
Secondary Outcome Measures
VAS
visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01626625
Brief Title
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing of Fracture
Keywords
nonunion, stem cells, autograft, hydroxyapatite
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stem cells
Arm Type
Experimental
Arm Description
stem cells + hydroxy apatite
Arm Title
autograft
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
stem cells + hydroxy apatite
Intervention Description
patient will be transplanted with stem cells and hydroxyapatite
Intervention Type
Other
Intervention Name(s)
autograft taken from iliac crest
Intervention Description
patient will be transplanted with autograft
Primary Outcome Measure Information:
Title
healing of fracture
Description
radiological union
Time Frame
1 year
Secondary Outcome Measure Information:
Title
VAS
Description
visual analogue scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
athropic nonunion fracture of the long bone
Exclusion Criteria:
immunocompromise,
active infection,
pathological fracture,
ongoing hormonal therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phedy Phe, MD
Email
phedy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail HD, PhD
Email
phedy2@yahoo.com
Facility Information:
Facility Name
RSCM
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phedy
Email
phedy@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
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