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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769872
First Posted: January 17, 2013
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korea University Anam Hospital
Information provided by (Responsible Party):
Biostar
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Biostar:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Frequency of Adverse Events [ Time Frame: 32 weeks ]

Enrollment: 15
Study Start Date: January 2013
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769872


Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Biostar
Korea University Anam Hospital
Investigators
Principal Investigator: Tai-Hyoung Cho, M.D. & Ph.D. Korea University Anam Hospital
  More Information

Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01769872     History of Changes
Other Study ID Numbers: KSC-MSCs-SPI
First Submitted: January 15, 2013
First Posted: January 17, 2013
Last Update Posted: August 2, 2016
Last Verified: August 2016

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