Multiroute administration of Wharton’s jelly mesenchymal stem cells in chronic complete spinal cord injury: A phase I safety and feasibility study

Table 1 Enrollment criteria and assessment timeline

Criteria	Details
Inclusion criteria	Age ≥ 18 years
	Radiologically confirmed chronic SCI
	No chronic illnesses (e.g., cancer, organ failure)
	Life expectancy > 12 months
	Severe disability (wheelchair-bound, assistance required)
	No significant functional improvement for at least 3 months
	Commitment to standard care and follow-up
	Provide written informed consent
Exclusion criteria	Significant medical/psychiatric conditions affecting safety
	Recent severe infections (meningitis, sepsis, etc.)
	Uncontrolled seizure disorder
	CNS neoplasm or cancer history (last 5 years)
	Abnormal blood cell counts (WBC ≥ 15000/μL, platelets ≤ 100000/μL)
	Abnormal liver/kidney function (AST/ALT > 3 × ULN, creatinine > 1.5 × ULN)
	Prior participation in other investigational stem cell trials
	Patient decision to withdraw or death during study
Treatment timeline	Baseline assessment (week 0): Neurological and functional evaluations
	MSC therapy initiation (week 1-8): 4 rounds of triple-route administration
	Short-term follow-up (weeks 1-12): Safety and early functional outcomes
	Mid-term assessment (month 6): Progress evaluation
	Long-term follow-up (month 12): Final outcome assessment

SCI: Spinal cord injury; CNS: Central nervous system; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; ULN: Upper limit of normal; MSC: Mesenchymal stem cell.