Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial
A research on Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial has been done by Prof. MD. Liem-Thanh Nguyen and Kien-Trung Nguyen (Vinmec Research Institute of Stem cell and Gene technology). Results have been presented and discussed at the 3th Vinmec International Conference on Cell and Gene Therapy (VCGT-2019), on 31/10/2019 in Hanoi.
Kien-Trung Nguyen, Liem-Thanh Nguyen
Vinmec Research Institute of Stem cell and Gene technology
ABSTRACT
BACKGROUND:
Although 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.
METHODS:
This 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 six 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.
RESULTS:
In this trial, we observed significant improvement in gross motor function and a significant decrease in muscle tone values. The 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). Besides, a significant reduction was observed in muscle tone scores after the transplantations (p-value < 0.05).
CONCLUSION:
Autologous BMMC transplantation can improve gross motor function and muscle tone in children with CP related to neonatal icterus.