Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial
Trial Parameters
Brief Summary
This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria: Age: 18 to 65 years (inclusive), regardless of gender. Etiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors. Severity: Classified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury. Disease Stage: Primary SCI occurring 14 to 60 days prior to screening (subacute phase). Contraception: Participants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion. Compliance: Voluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent. Exclusion Criteria: * Neurological Inability Primary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment. Respiratory/Circulatory Instability Hi