Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Biological/cell based
General health
Online since 10 November 2021, updated 838 days ago

About this trial

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to eit...

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - T1
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 5 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T1

    What’s involved

    Type

    Biological/cell based

    Details

    Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 2:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health

    Pain

    Spasticity

    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
    • 13 Oct 2021
    • Organisation
    • Banc de Sang i Teixits
    • Trial recruitment status
    • Ended
    • Trial start date
    • 13 Oct 2021
    • Organisation
    • Banc de Sang i Teixits

    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