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

Phase 1

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01624779
• Lead Sponsor: Bukwang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Significant MRI Change before and after intervention	6 month

Secondary Outcome Measures

Name	Time	Method
Significant Electrophysiological Change before and after intervention	6 month
Significant neurologic funtion Change before and after intervention	6 month
Adverse event	6 month

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Seongbukgu, Korea, Republic of