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 XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.
Study Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.
Who Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).
Study Plan:
Phase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.
Follow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.
What Researchers Are Looking For:
Primary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.
Secondary Goals:
Improvement in ASIA Impairment Scale (AIS) grade (e.g., from "complete" to "incomplete" paralysis).
Recovery of sensation and bladder/bowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.
Why This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.
Age: 18 to 65 years (inclusive), regardless of gender.
Neurological Inability
Parallel
Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
Biological/VaccineDescription: XS228 Cell Injection is an investigational, allogeneic cell therapy product composed of motor neuron progenitor cells (MNPCs) derived from human induced pluripotent stem cells (iPSCs). This advanced therapy medicinal product (ATMP) is being developed for the treatment of spinal cord injury (SCI) and represents a novel approach in regenerative medicine.
Placebo
Other interventionStandard rehabilitation protocols
Improvement in ASIA Impairment Scale (AIS) grade
Changes in American Spinal Injury Association (ASIA) Motor Score
Changes in motor scores assessed by the ASIA score scale (total score range from 0 to 100, higher values represent a better outcome)
Changes in American Spinal Injury Association (ASIA) Sensory Score
Changes in sensory scores assessed by the ASIA score scale (total score range from 0 to 224, higher values represent a better outcome)
Changes in Spinal Cord Independence Measure-III (SCIM-III)
SCIM-III(range: 0-100, with lower score indicating greater disability)
Safety and Tolerability
Description: Systematic evaluation of: Adverse events (AEs) up to 360 days post-infusion Immunogenicity (anti-HLA antibodies, T-cell responses) Assessment Methods: CTCAE v5.0 grading Neurological monitoring (ISNCSCI exams) CSF analysis for inflammation markers
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XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
