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 3 June 2025, updated 155 days ago

About this trial

Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS22...

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

    Healthy volunteers
    No
    C4-L2

    What’s involved

    Type

    Biological/cell based

    Details

    Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate the Efficacy and Safety of XS228 Cell Injection in Patients with Subacute Thoracic or Lumbar SCI Study Type: Interventional (Clinical Trial) Phase: Phase II Allocation: Randomized (2:1, XS228 vs. Placebo) Masking: Double-blind (Participant, Investigator) Primary Purpose: Treatment Hypothesis: XS228 (allogeneic iPSC-derived motor neuron progenitor cells) will demonstrate statistically significant improvement in motor function (ASIA Motor Score) compared to placebo at 6 months post-treatment. The therapy will exhibit an acceptable safety profile with no dose-limiting toxicities (DLTs). Intervention Details Investigational Product: XS228 Cell Injection: Cryopreserved suspension of optimal dose from Phase I. Placebo: Normal saline with identical packaging/labeling. Administration: 4 intrathecal injection via lumbar puncture (Day 0, Day 14, Day 28 and Day 42). Concomitant Therapies: Standard rehabilitation protocols (uniform across sites). Prohibited: Other experimental therapies or stem cell treatments during the study.

    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
    • Third Affiliated Hospital, Sun Yat-Sen University
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 25 May 2028
    • Organisation
    • Third Affiliated Hospital, Sun Yat-Sen 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