Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

August 1, 2016 updated by: R-Bio
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • 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

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

17 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study
  • Age : 19-70
  • Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
  • Duration of injury : > 3 month

Exclusion Criteria:

  • Subjects who must put on a respirator
  • Subjects who had malignant tumor within 5 years
  • Subjects with a infectious disease include HIV and hepatitis
  • Subjects who injured brain or spinal cord before spinal cord injury
  • Subjects with anemia or thrombocytopenia
  • Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
  • Subjects with congenital or acquired immunodeficiency disorders
  • Patients with clouded consciousness or speech disorder
  • treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
  • participating another clinical trials within 3 months
  • other serious disease or disorder that could seriously affect ability to participate in the study

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Adipose Tissue derived MSCs
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASIA (American Spinal Injury Association) scale
Time Frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging
Time Frame: 32 weeks
To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.
32 weeks
MEP/SSEP
Time Frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks
ADL (activities of daily living)
Time Frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks
SF-36
Time Frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks
ODI (Oswestry Disability Questionnaire)
Time Frame: 32 weeks
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
32 weeks
Frequency of Adverse Events
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

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

Sponsor

R-Bio

Collaborators

Korea University Anam Hospital

Investigators

  • Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D., 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

January 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSC-MSCs-SPI

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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