NCT01274975CompletedPhase 1
Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
R-Bio0 sites8 target enrollmentStarted: July 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Primary Endpoint
- safety evaluation
Study Overview
Brief Summary
This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.
Detailed Description
Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.
With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased.
In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
safety evaluation
Time Frame: 12weeks
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Unknown
Not Applicable
Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem CellsKnee OsteoarthritisNCT03956719Qilu Hospital of Shandong University8
Unknown
Phase 1
Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage InjuryCartilage DegenerationKnee OsteoarthritisNCT03955497Qilu Hospital of Shandong University30
Not yet recruiting
Phase 1
Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 DiseaseCovid-19 PneumoniaCyotokine StormNCT04352803Regeneris Medical20
Completed
Phase 1
Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone DeficiencyHormone DeficiencyNCT03346967Vinmec Research Institute of Stem Cell and Gene Technology30
Completed
Early Phase 1
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CPCerebral PalsyNCT03979898R-Bio1