Evaluation of stem/stromal cell transplantation safety and efficacy in children diagnosed with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials

Cerebral palsy is a neurological disorder that affects both postnatal and prenatal children. It results from brain damage in the cerebral motor cortex. The three types of CP are spastic, dyskinetic, and mixed forms. This study aims to evaluate the efficacy and safety of stem or stromal cell therapy in children diagnosed with cerebral palsy. A systematic search was conducted across four databases: PubMed, ISI Web of Science, Scopus, and Embase from inception to August 23, 2024, to identify studies evaluating the efficacy and safety of stem cell therapy for cerebral palsy. Data extraction was performed for all randomized controlled clinical studies. ROB2 (Risk of Bias Tool 2) was used to assess the risk of bias in the included studies. The main outcome measures were extracted from each study for meta-analysis, and a PRISMA flow diagram was used to illustrate the study selection process. Eventually, thirteen studies met the inclusion criteria. The Gross Motor Function Measure (GMFM) is crucial for assessing motor function changes and evaluating the impact of stem cell therapy. Subgroup analysis of GMFM scores were conducted based on assessment time points (3, 6, and 12 months post-treatment), route of administration, and type of stem cell used. The results demonstrate that stem cell therapy remarkably improved GMFM score in the treatment group. For safety analysis, adverse events such as irritability, fever, nausea, and vomiting were assessed, and risk ratios (RRs) were calculated to confirm the safety of stem cell therapy. The findings suggest that stem cell transplantation was safe and effective for treating cerebral palsy. However, further high-quality RCTs with standardized protocols are necessary to investigate the efficacy of alternative stem cell types for cerebral palsy.