Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial

Biological/cell based
General health
Online since 15 October 2025, updated 56 days ago

About this trial

This trial is enrolling 12 participants with acute spinal cord injury to test the safety and tolerability of a cell therapy (XS228) made from lab-grown nerve cells that may support and repair nerves. If included, participants will receive a single intraspinal injection of XS228 at one of two escalating dose levels (5×10⁷ or 1.5×10⁸ cells), followed by standard rehabilitation. Final testing of safety and tolerability 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
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C4-L2

    What’s involved

    Type

    Biological/cell based

    Details

    - Participants will receive a single intraspinal injection of XS228 at one of two escalating dose levels (5×10⁷ or 1.5×10⁸ cells), followed by standard rehabilitation. - XS228 is a treatment made from lab-grown nerve cells that support and repair nerves. - Final testing of safety and tolerability 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
    • Trial start date
    • 2 Jul 2025
    • Organisation
    • XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 2 Jul 2025
    • 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