iPSC-Derived Motor Neuron Cells’ Dose Escalation Trial for Subacute Spinal Cord Injury, a Phase I
This study will evaluate if allogeneic human induced pluripotent stem cell (iPSC)-derived motor neuron progenitor cells (XS228, made by XellSmart) can safely and effectively treat subacute spinal cord injury. Researchers at the Third Affiliated Hospital, Sun Yat-Sen University, in collaboration with XellSmart Biomedical (Suzhou) Company, will administer XS228 cell injections in a Phase I dose-escalation […]
This study will evaluate if allogeneic human induced pluripotent stem cell (iPSC)-derived motor neuron progenitor cells (XS228, made by XellSmart) can safely and effectively treat subacute spinal cord injury. Researchers at the Third Affiliated Hospital, Sun Yat-Sen University, in collaboration with XellSmart Biomedical (Suzhou) Company, will administer XS228 cell injections in a Phase I dose-escalation trial involving 12 participants. The trial mentions that the investigational therapy consists of motor neuron progenitor cells derived from human iPSCs, characterized by over 90% purity and specific markers including PAX6, OLIG2, and HB9, produced under GMP-compliant and animal-component-free conditions.
Participants will first undergo screening assessments, including MRI/DTI imaging, electrophysiological testing, and laboratory evaluations to confirm eligibility. Following this, they will receive an intraspinal transplantation of XS228 cells at assigned doses. Researchers will systematically track acute and subacute adverse events for up to 28 days post-infusion, dose-limiting toxicities within 90 days, and immunogenicity responses such as anti-HLA antibodies and T-cell reactions. Safety assessments will use CTCAE v5.0 grading, neurological monitoring via ISNCSCI exams, and cerebrospinal fluid analysis for inflammation markers. Secondary outcomes will include evaluating improvements in ASIA Impairment Scale (AIS) grades at intervals up to one year.
Participants will be monitored over one year, with repeated neurological examinations, imaging, laboratory tests, and adherence to rehabilitation protocols documented. Researchers aim to determine the maximum tolerated dose and dose-limiting toxicity profile of XS228 cells. They expect to finish the trial in May of 2028.
Link to trial:
https://clinicaltrials.gov/study/NCT06976229
