Abstract
BackgroundAlthough stem cell transplantation has been successfully performed for cerebral palsy (CP) related to oxygen deprivation, clinical trials involving the use of stem cell transplantation for CP related to neonatal icterus have not been reported. The aim of this study was to evaluate the effectiveness of transplantation of autologous bone marrow mononuclear cell (BMMC) for improving gross motor function and muscle tone in children with CP related to neonatal icterus.MethodsThis open-label, uncontrolled clinical trial, which included 25 patients with CP related to neonatal icterus who had a Gross Motor Function Classification System (GMFCS) score between level II and level V, was conducted between July 2014 and July 2017 at Vinmec International Hospital (Vietnam). BMMC were harvested from the patients’ iliac crests. Two procedures involving BMMC transplantation via the intrathecal route were performed: the first transplantation was performed at baseline, and the second transplantation was performed 6 months after the first transplantation. Gross motor function and muscle tone were measured at three time points (baseline, 6 months, and 12 months) using the Gross Motor Function Measure (GMFM) and the Modified Ashworth Scale.ResultsIn this trial, we observed significant improvement in gross motor function and a significant decrease in muscle tone values. Total score on the 88-item GMFM (GMFM-88), scores on each GMFM-88 domain, and the 66-item GMFM (GMFM-66) percentile were significantly enhanced at 6 months and 12 months after the first transplantation compared with the corresponding baseline measurements (p-values < 0.05). In addition, a significant reduction was observed in muscle tone score after the transplantations (p-value < 0.05).ConclusionAutologous BMMC transplantation can improve gross motor function and muscle tone in children with CP related to neonatal icterus.Trial registrationClinicalTrials.gov identifier: NCT03123562. Retrospectively registered on December 26, 2017.
Highlights
Stem cell transplantation has been successfully performed for cerebral palsy (CP) related to oxygen deprivation, clinical trials involving the use of stem cell transplantation for CP related to neonatal icterus have not been reported
The aim of this study was to assess improvement in gross motor function and muscle tone in children with CP related to neonatal icterus after bone marrow mononuclear cell (BMMC) transplantation
To our knowledge, this report describes the first clinical trial to assess the impact of autologous BMMC transplantation on motor function and muscle tone in children with CP related to neonatal icterus
Summary
Stem cell transplantation has been successfully performed for cerebral palsy (CP) related to oxygen deprivation, clinical trials involving the use of stem cell transplantation for CP related to neonatal icterus have not been reported. Neonatal icterus is a physiological condition that affects 60–70% of newborns worldwide [1]. It is estimated that 50% of term infants and 80% of preterm infants develop icterus, which typically manifests 2–4 days after birth. Neonatal icterus responds well to phototherapy, albumin infusion, or blood exchange [2, 3]. Neonates with unconjugated hyperbilirubinemia can develop acute encephalopathy with focal necrosis of neurons and glia. Acute bilirubin encephalopathy affects long-term neurodevelopmental outcomes. The risk for CP in neonates with hyperbilirubinemia was found to be 0.57 per 100, 000 births [14]
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