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

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

The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: autologous adipose tissue derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongbukgu
    • Seoul, Seongbukgu, Korea, Republic of, 136-705
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Significant MRI Change before and after intervention	6 month

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Investigators: Principal Investigator: Taehyeong Jo, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: autologous adipose tissue
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: KOR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No