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Different underlying mechanisms of action have been described to justify the potential efficacy of stem cell therapy. The optimal dose, the most appropriate type of cell, and the best route of cell administration should be identified to provide safe and effective protocols without raising ethical concerns. To date, many aspects of cell-based therapy remained unknown. Several studies assessed the safety and efficacy of different stem cells in the treatment of individuals diagnosed with stroke, multiple sclerosis, Parkinson’s disease, Huntington’s disease, and spinal cord injury. The central nervous system (CNS) is unable to regenerate new cells and damages to CNS can be permanent. There has been greater interest in the use of stem cell therapy in recent years especially for the treatment of neurological disorders. Stem cells are defined as pluripotent cells with the ability of self-renewal and the capacity of differentiation into the other cell types. The study was registered with ( NCT03795974). The UCT-MSC transplantation was safe and may improve the clinical and imaging outcomes. The mean changes were significantly higher than the control group. The DTI analysis in the experimental group showed that mean FA increased (CST 0.032 95%CI 0.02, 0.03. Regarding CP-QoL, mean changes in domains including friends and family, participation in activities, and communication were higher than the control group with a large effect size. The mean change in MAS scores after 12 months of cell injection reduced compared to baseline (−1.0 95%CI −1.31, −0.69) and control ( β −0.72 95%CI −1.18, −0.26 Cohen’s d 0.76). The mean GMFM-66 scores after 12 months of intervention were significantly higher in the UCT-MSC group compared to baseline (10.65 95%CI 5.39, 15.91) and control ( β 8.07 95%CI 1.62, 14.52 Cohen’s d 0.92). There were 36 participants in each group. Secondary endpoints were the mean changes in fractional anisotropy (FA) and mean diffusivity (MD) of corticospinal tract (CST) and posterior thalamic radiation (PTR). The mean changes in the modified Ashworth scale (MAS), pediatric evaluation of disability inventory (PEDI), and CP quality of life (CP-QoL) were also assessed. The primary endpoints were the mean changes in gross motor function measure (GMFM)-66 from baseline to 12 months after procedures. All individuals were sedated to prevent awareness. Small needle pricks to the lower back were performed in the sham-control arm. Single-dose (2 × 10 7) cells were administered in the experimental group. Participants (4–14 years old) with spastic CP were assigned in 1:1 ratio to receive either UCT-MSC or sham procedure. The diffusion tensor imaging (DTI) was performed to evaluate the alterations in white-matter integrity.
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This study assessed the safety and efficacy of intrathecal injection of umbilical cord tissue mesenchymal stem cells (UCT-MSC) in individuals with cerebral palsy (CP).