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

February 11, 2015 updated by: Bukwang Pharmaceutical

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Significant neurologic funtion Change before and after intervention
Time Frame: 6 month
6 month
Significant Electrophysiological Change before and after intervention
Time Frame: 6 month
6 month
Adverse event
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Investigators

  • Principal Investigator: Taehyeong Jo, PhD, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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