Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury

Biological/cell based
Standing/walking/mobility
Online since 4 November 2021, updated 895 days ago

About this trial

This trial is recruiting individuals with chronic spinal cord injuries to study whether implanted stem cells derived from human umbilical cord tissue or umbilical cord blood (hUC-MSCs or hUCB-MSCs) are safe using various forms of injection. The trial will also determine whether the stem cells change locomotor (walking) function and/or muscle tension. Participants will be randomly assigned to one of seven groups. One arm is a control group that receives a placebo injection; the other six arms vary the placement of stem cell injections (e.g., into the blood stream, into the injury area, etc.) All participants will also receive standard rehabilitative care. After 1, 3, 6, and 12 months, each participant will be evaluated in terms of safety and changes in function.

Included participants

Gender
All
Age
20 - 65 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5

    What’s involved

    Type

    Biological/cell based

    Details

    The participant will receive either 1) intravenous injections of hUC-MSCs/hUCB-MSCs, 2) hUC-MSCs/hUCB-MSCs injections into the fluid around the lower spinal cord, 3) hUC-MSCs/ hUCB-MSCs into the injured area of the spinal cord, or 4) a control intravenous injection of saline as a placebo control. After 1, 3, 6, and 12 months, the participant will be evaluated in terms of safety and potential efficacy of the cell transplantation.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Pain

    Sensory function

    Spasticity

    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
    • Unknown
    • Trial start date
    • 1 Jan 2018
    • Organisation
    • The First Affiliated Hospital of Dalian Medical University
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Jan 2018
    • Organisation
    • The First Affiliated Hospital of Dalian Medical University

    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