Overview

Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bukwang Pharmaceutical
Criteria
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