Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial

Biological/cell based
General health
Online since 20 November 2025, updated 13 days ago

About this trial

This Phase II trial is enrolling 60 participants with acute spinal cord injury to test the effect of a nerve-supporting stem cell product injected into the spinal fluid. The cells (XS228) are derived from lab-grown nerve cells that support and repair nerves. If included, participants will be randomly assigned to receive either XS228 cells or a placebo, delivered via 4 spinal fluid injections over 6 weeks, alongside standard rehabilitation. Final testing for arm and leg function, sensation, bladder/bowel function, and safety will be performed after 1 year.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C4 - L2
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    14 days - 60 days
    Healthy volunteers
    No
    C4-L2

    What’s involved

    Type

    Biological/cell based

    Details

    - Participants will be randomly assigned to receive either XS228 or a placebo, delivered via 4 spinal fluid injections over 6 weeks, alongside standard rehabilitation. - XS228 is a treatment made from lab-grown nerve cells that support and repair nerves. - Final testing will be performed after 1 year.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Bladder health/function

    Bowel health

    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
    • Recruiting soon
    • Trial start date
    • 25 May 2028
    • Organisation
    • XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 25 May 2028
    • Organisation
    • XellSmart Bio-Pharmaceutical (Suzhou) 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