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

This study is currently recruiting participants.
Verified January 2013 by RNL Bio Company Ltd.
Sponsor:
Collaborator:
Korea University Anam Hospital
Information provided by (Responsible Party):
RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:
NCT01769872
First received: January 15, 2013
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
 Procedure: Autologous Adipose Tissue derived MSCs Transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RNL Bio Company Ltd.:

Primary Outcome Measures:
  • ASIA (American Spinal Injury Association) scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.


Secondary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.

  • MEP/SSEP [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

  • ADL (activities of daily living) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

  • SF-36 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

  • ODI (Oswestry Disability Questionnaire) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

  • Frequency of Adverse Events [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769872

Contacts
Contact: Tai-Hyoung Cho, M.D. & Ph.D. 82-10-3791-5338 choth2@korea.ac.kr

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tai-Hyoung Cho, M.D. & Ph.D.     82-10-3791-5338     choth2@korea.ac.kr    
Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D.            
Sub-Investigator: Dong-Hyuk Park, M.D. & Ph.D.            
Sub-Investigator: Jang-Bo Lee, M.D. & Ph.D.            
Sub-Investigator: Sang-Heon Lee, M.D. & Ph.D.            
Sponsors and Collaborators
RNL Bio Company Ltd.
Korea University Anam Hospital
Investigators
Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: RNL Bio Company Ltd.
ClinicalTrials.gov Identifier: NCT01769872     History of Changes
Other Study ID Numbers: RB-MSCs-SPI
Study First Received: January 15, 2013
Last Updated: January 17, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013