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

Spinal Cord Injury Clinical Trial

Official title:

The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624779
• Other study ID #: KOR-01
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2012
• Last updated: February 11, 2015
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2012
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbukgu

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant MRI Change before and after intervention		6 month	No
Secondary	Significant neurologic funtion Change before and after intervention		6 month	No
Secondary	Significant Electrophysiological Change before and after intervention		6 month	No
Secondary	Adverse event		6 month	Yes