Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
MSC
Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
1 other identifier
interventional
8
0 countries
N/A
Brief Summary
This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2009
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedMarch 26, 2014
March 1, 2014
4 months
January 6, 2011
March 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
safety evaluation
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
12weeks
Interventions
Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
Eligibility Criteria
You may qualify if:
- Subjects who understand and sign the consent form for this study.
- Age :19-60, males
- Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
- Duration of injury : \> 2 months
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 who has high body temperature more than 38℃ or acute disorder
- 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
- Subjects with muscular dystrophy or articular rigidity
- 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
Related Publications (1)
Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
PMID: 21303266RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SangHan Kim, MD
Anyang Sam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 12, 2011
Study Start
July 1, 2009
Primary Completion
November 1, 2009
Study Completion
February 1, 2010
Last Updated
March 26, 2014
Record last verified: 2014-03