General Information |
| Summary |
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. |
| Description |
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 1, Day 15, Day 29 and Day 43).
Concomitant Therapies:
Standard rehabilitation protocols (uniform across sites). Prohibited: Other experimental therapies or stem cell treatments during the study. |
| Clinical trials phase |
Phase 2 |
| Start date (estimated) |
2028-05-25 |
| End date (estimated) |
2031-05-26 |
| Clinical feature |
| Label |
Spinal cord injury |
| Link |
http://www.orpha.net/ORDO/Orphanet_90058 |
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Administrative Information |
| NCT number |
NCT06974968 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06974968 |
| Other study identifiers |
| Name |
XS228-Allo-SCI-CN2-P01 |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06974968 |
| Study sites |
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| Sponsors |
Third Affiliated Hospital, Sun Yat-Sen University
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| Collaborators |
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Cells |
| Which differentiated cell type is used |
| Label |
motor neuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000100 |
| Description |
An efferent neuron that passes from the central nervous system or a ganglion toward or to a muscle and conducts an impulse that causes or inhibits movement.; Motor neurons, also known as motoneurons, are a type of neural cell that is fundamental to voluntary movement of muscles. Located within the central nervous system (CNS), motor neurons in the motor cortex travel to the brainstem and spinal cord. Motor neurons in the brainstem and spinal cord extend their lengthy axons out to muscles throughout the body. These specialized neurons are an inherent part of the so-called somatic division of the nervous system which mediates conscious control of skeletal muscles.
The primary function of motor neurons is to relay signals from the CNS to the body's many muscles, controlling both their contraction and relaxation. In response to impulses transmitted from the brain or spinal cord, it creates an electrical signal (action potential), which travels along its axon to cause the controlled movement of specific muscles. Motor neurons can connect with skeletal muscles, cardiac muscles, or glands, leading to three respective types: somatic motor neurons, autonomic motor neurons, and the neurons of the enteric nervous system.
Key components of motor neurons include the cell body (soma), dendrites, and axons. The cell body houses the nucleus and is the site of the neuron's intrinsic functions. Dendrites are thin structures that branch from the cell body and receive messages (electrical signals) from other neurons. The axon, a long, single tail-like extension, carries these signals away from the cell body towards the targeted muscle. If a motor neuron is damaged or dies, the muscle or gland it controls can lose function, which can result in conditions like motor neuron disease, leading to muscle weakness and atrophy.
(This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies only to some subtypes and species, and so should not be considered definitional.) |
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Recruitment |
| Recruitment Status |
Not yet recruiting |
| Estimated number of participants |
60 |
| Contact institutions/departments |
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