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Completed

NCT Number: NCT01769872

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

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

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Adipose Tissue derived MSCs Transplantation

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Frequency of Adverse Events

    Time frame: 32 weeks

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Collaborators

  • Korea University Anam Hospital

Registry information

Important dates

Study start
2013
Primary completion
2016
First posted
Jan 17, 2013
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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