Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedAugust 2, 2016
August 1, 2016
3 years
January 15, 2013
August 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
ASIA (American Spinal Injury Association) scale
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks
Secondary Outcomes (6)
Magnetic Resonance Imaging
32 weeks
MEP/SSEP
32 weeks
ADL (activities of daily living)
32 weeks
SF-36
32 weeks
ODI (Oswestry Disability Questionnaire)
32 weeks
- +1 more secondary outcomes
Study Arms (1)
Autologous Adipose Tissue derived MSCs
EXPERIMENTALInterventions
Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL
Eligibility Criteria
You may qualify if:
- Subjects who understand and sign the consent form for this study
- Age : 19-70
- Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
- Duration of injury : \> 3 month
You may not qualify if:
- Subjects who must put on a respirator
- Subjects who had malignant tumor within 5 years
- Subjects with a infectious disease include HIV and hepatitis
- Subjects who injured brain or spinal cord before spinal cord injury
- Subjects with anemia or thrombocytopenia
- Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
- Subjects with congenital or acquired immunodeficiency disorders
- Patients with clouded consciousness or speech disorder
- treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
- participating another clinical trials within 3 months
- other serious disease or disorder that could seriously affect ability to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Biolead
- Korea University Anam Hospitalcollaborator
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tai-Hyoung Cho, M.D. & Ph.D.
Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2013
First Posted
January 17, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2016
Last Updated
August 2, 2016
Record last verified: 2016-08