Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

Biological/cell based
General health
Online since 1 November 2021, updated 929 days ago

About this trial

This clinical trial is recruiting individuals with chronic incomplete cervical (neck area) spinal cord injuires to test the safety and effectiveness of transplanted stem cells (autologous mesenchymal stem cells). The stem cells are harvested and processed from each participant’s bone marrow, limiting any immune rejection response. Participants will undergo spinal surgery to expose the spinal cord, followed by the injection of the stem cells into the spinal cord and surrounding spinal fluid. After surgery, participants will receive 4 weeks of physical and occupational training. This study will investigate changes in motor and sensory function.

Included participants

Gender
All
Age
16 - 65 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-B
    Time since injury
    12 months - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NOT have undergone major surgery in past 3 months
    NOT be dependent on mechanical ventilator
    NOT have penetrating injury, e.g. gunshot or stab wound

    What’s involved

    Type

    Biological/cell based

    Details

    The total duration of this study is approximately one year and involves the following: Undergo a procedure to harvest bone marrow cells Spinal surgery to inject the bone marrow-derived stem cells into the spinal cord and surrounding spinal fluid 4 weeks of physical and occupational therapy Assessment of outcome measures 24 hours, 1 month, 3 months, 6 months and 12 months after surgery

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Sensory function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Aug 2008
    • Organisation
    • Pharmicell Co., Ltd.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Aug 2008
    • Organisation
    • Pharmicell Co., Ltd.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more