Status:
UNKNOWN
Allogenic Mesenchymal Stem Cell for Bone Defect or Non Union Fracture
Lead Sponsor:
Indonesia University
Conditions:
Non Union Fracture
Metaphyseal Fibrous Defect
Eligibility:
All Genders
19-30 years
Phase:
EARLY_PHASE1
Brief Summary
Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long b...
Detailed Description
Research Methods Study Design This study is an experimental one arm study post test only. Estimated Study Time Research estimated time would be 24 months, from May 2014 to May 2016. Sample Gaining Pro...
Eligibility Criteria
Inclusion
- Inclusion criteria for MSC donor
- Bone marrow donor : Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease),HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
- Adipose donor : Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
- Umbilical cord donor : Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.
- exclusion / Drop out criteria
- Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.
- inclusion criteria for recipient : -male/female aged 6-55 year old with bone critical defect
- exclusion criteria for recipient :
- Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02307435
Start Date
August 1 2014
End Date
December 1 2017
Last Update
December 4 2014
Active Locations (2)
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1
University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
2
Faculty of Medicine, University of Indonesia
Propinsi DKI Jakarta, Jakarta Special Capital Region, Indonesia, 16424