Spinal Cord Injury
Conditions
Keywords
autologous adipose tissue
Brief summary
The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.
Interventions
DRUGautologous adipose tissue derived mesenchymal stem cells
autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
Sponsors
Bukwang Pharmaceutical
Study design
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury 2. No change in neurological function for 4weeks interval by at least 2 clincal medical specialists 3. Patient who is able to give written informed consent of clinical trial about stemcells treatment
Exclusion criteria
1. Patient who is under 19 years and over 70years 2. Patient who must use the mechanical ventilator 3. Patient who have a history of malignant tumor within 5 years 4. Patient who is having a infectious disease of including current hepatitis and HIV 5. Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history) 6. Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day 7. Patient who is having an anemia or thrombopenia 8. Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history) 9. Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history) 10. Patient who is having an amyotrophia or joint atrophy 11. Patient who is having an disturbanace of consciousness or dysphrasia 12. Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration 13. Patient who have experienced another clinical trials within 3 months involving this clinical trial 14. Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant MRI Change before and after intervention | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Significant neurologic funtion Change before and after intervention | 6 month |
| Significant Electrophysiological Change before and after intervention | 6 month |
| Adverse event | 6 month |
Countries
South Korea
Outcome results
None listed