Spinal Cord Injury
Conditions
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.
Interventions
Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
Sponsors
R-Bio
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety evaluation | 12weeks | Safety evaluate through physical examination, vital sign and laboratory test after RNL-Astrostem injected |
Outcome results
None listed