Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy

Feasibility was defined as successful delivery of the intended dose of allogeneic umbilical cord-derived mesenchymal stromal cells (UCT-MSCs), completion of the intrathecal administration without technical failure, completion of the planned post-procedural observation, participant retention through the 6-month follow-up, and absence of protocol deviations preventing completion of the intervention or follow-up.

Safety was assessed by recording immediate and delayed treatment-emergent adverse events occurring during the procedure, during hospitalization, and throughout the 6-month follow-up period. Events of interest included fever, vomiting, headache, irritability, back pain, local procedural complications, infection, allergic or infusion-related reactions, seizure, altered consciousness, neurological deterioration, prolonged hospitalization, and serious adverse events. For each adverse event, the time of onset, maximum severity, duration, management, clinical outcome, seriousness, and investigator-assessed relationship to the intervention were documented.

Gross motor function was classified using the Gross Motor Function Classification System (GMFCS), a five-level ordinal classification system ranging from Level I (least severe limitation) to Level V (most severe limitation). Changes in GMFCS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.

Manual ability was classified using the Manual Ability Classification System (MACS), a five-level ordinal classification system ranging from Level I to Level V. Changes in MACS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.

Communication performance was assessed using the Communication Function Classification System (CFCS), a five-level ordinal classification system describing everyday communication performance. Results were summarized descriptively and were not interpreted as evidence of treatment efficacy.

Eating and drinking ability was classified using the Eating and Drinking Ability Classification System (EDACS), a five-level ordinal classification system. Changes in EDACS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.

Spasticity was assessed using the Modified Ashworth Scale (MAS), an ordinal scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Muscle groups evaluated were assessed according to the study protocol. MAS scores were summarized descriptively because the scale is ordinal and may be influenced by positioning, participant cooperation, and assessor judgment.