Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial

Ki vehet részt

• 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

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• Neurological Inability; Primary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment; Respiratory/Circulatory Instability; High cervical SCI (C1-C3) causing respiratory/circulatory compromise requiring endotracheal intubation or tracheostomy; Life-Threatening Multiorgan Dysfunction; Concurrent severe injuries to other organ systems with life-threatening dysfunction; Unstable Thoracoabdominal Injuries; Injuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator; Prior Spinal Pathology; History of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary/metastatic spinal tumors, spinal vascular malformations, syringomyelia); Local Infection/Increased ICP; Active infection at the lumbar puncture site or intracranial hypertension during screening; Severe Infections; Sepsis, septic shock, or severe pneumonia (per IDSA/ATS 2007 diagnostic criteria); Confounding Neurological/Psychiatric Conditions; Parkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments; Cardiac Abnormalities (any of the following):; Congestive heart failure (NYHA Class III/IV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block); Unstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications; Pulmonary hypertension, pulmonary embolism, or suspected embolism during screening; Uncontrolled Hypertension/Hypotension; Systolic BP >160 mmHg or diastolic BP >100 mmHg; or systolic BP <90 mmHg or diastolic BP <60 mmHg; Active Autoimmune Diseases; Requiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus); Immunosuppressant Non-Compliance; Unwillingness or inability to use immunosuppressants per protocol; Laboratory Abnormalities (any of the following):; ALT/AST >2×ULN or total bilirubin >2×ULN. eGFR <60 mL/min/1.73m² (CKD-EPI 2021 formula). APTT/PT >2.5×ULN (without anticoagulants). Platelets <100×10⁹/L or hemoglobin <90 g/L. Allergy; History of severe allergies or hypersensitivity to trial drug/excipients (human albumin, lactated Ringer's solution); Infectious Diseases; HBsAg+ with HBV DNA >1000 IU/mL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal; Unwillingness to undergo intrathecal administration procedures. Pregnancy/Lactation; Females who are pregnant or breastfeeding. Malignancy; Active malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation; Enrollment in another drug trial within 3 months prior. Investigator Discretion; Any condition deemed unsuitable for participation by the investigator