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

NCT ID: NCT01624779

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-05-31

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.

Conditions

Spinal Cord Injury

Study Design

• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous adipose tissue derived mesenchymal stem cells

autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1\&2

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taehyeong Jo, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, Seongbukgu, South Korea

Countries

South Korea

Other Identifiers

KOR-01

Identifier Type: -

Identifier Source: org_study_id