The Single-center Study Of Human Neural Stem Cell For Chi Ldren With Cerebral Palsy By Olfactory Channel

Objective:cerebral palsy is a persistent motor dysfunction and postural abnormalities caused by non-progressive brain damage in the fetus or infant（immature developing brain）.At present,the pathogenesis of cerebral palsy is still unclear,and there is a lack of targeted treatment measures in clinical practice.The effectiveness of neural stem cell transplantation in treating cerebral palsy has been controversial for many years.Entrusted by the National Health Commission（Record Number: 2019 No.017）,the research group plans to adopt a strict randomized controlled study（Registration Number:Chi CTR1900022119）to explore the safety and efficacy of intranasal transplantation of neural stem cells for the treatment of cerebral palsy,and to provide evidence-based medical basis for the clinical treatment of cerebral palsy with stem cells.Methods:Randomized,double-blind,placebo-controlled study methods.30 cases were randomly divided into experimental group（neural stem cell preparation group）and control group（placebo）and treatment group with neural stem cell transplantation therapy in combination with conventional rehabilitation training,the control group with placebo combined routine rehabilitation training,group 20 cases,10 cases of control group.Before treatment,1 month,3 months and 6 months after treatment,the gross Motor Function Scale（GMFM）,Fine Motor Function Scale（FMFM）and Gesell Development Scale（DQ）were used to evaluate the neurological function of the two groups,and the imaging changes were explored by head MRI plain scan.At the same time,physical examination was conducted in each visit period,and blood routine examination,liver and kidney function,tumor markers,immune function,urine routine examination,encephalogram,electrocardiogram and adverse reactions were monitored.Chi-square was used for statistical analysis of the count data,and independent T-test and repeated measurement analysis of variance were used for statistical analysis between the two groups and before and after treatment.Results:（1）GMFM assessment: there was no statistical difference between group and GMFM score,F（1,8）= 0.006,P > 0.05;During the screening period,1 month,3 months and 6 months of treatment,GMFM score of the two groups increased gradually with time,and the difference was statistically significant,that is,time effect point could significantly affect the change of GMFM score,F（3,24）=17.520,P < 0.05.（2）FMFM evaluation: During the screening period,at 1,3 and 6 months of treatment,THERE was no significant change in FMFM score,the difference was not statistically significant,F（3,24）=1.015,P > 0.05;There was no significant difference in FMFM score between the two groups（F（1,8）= 0.425,P > 0.05）.（3）DQ score: There were no significant changes in DQ values between the two groups during screening period,1 month,3months and 6 months of treatment,FDQ1（1.420,11.360）=1.942,FDQ2（1.536,12.288）=0.049.FDQ5（1.504,12.035）=1.373,P > 0.05;FDQ1（1,8）= 1.188,FDQ2（1,8）= 0.327,FDQ5（1,8）= 0.094,all P > 0.05;FDQ3（3,24）=7.541,FDQ4（3,24）=6.104,P < 0.05,but there was no significant difference in DQ between the two groups,FDQ3（1,8）= 0.650.FDQ4（1,8）= 0.758,P > 0.05;（3）: head MRI imaging findings of two groups of children with no change before and after the treatment:（4）safety indicators: the abnormal electrocardiogram（ecg）before and after treatment of two groups of children with 0,eeg abnormality rate in each period had no statistical significance（P > 0.05）,two groups of children with differences in the incidence of adverse reactions in various periods of no statistical significance（P > 0.05）.Conclusions:The gross motor,speech and cognitive abilities of the experimental group and the control group were improved after treatment,but there was no statistical difference between the two groups,indicating that the neural stem cell transplantation by olfactory channel had no effect on improving the functional dysfunction of the children.However,there were no significant abnormal changes in the safety indexes of the experimental group before and after treatment,and the incidence of adverse reactions was similar between the two groups,indicating that the neural stem cell transplantation transplantation by olfactory channel is safe for the treatment of cerebral palsy in children,which provides an evidence-based basis for exploring the treatment of cerebral palsy by nasal nerve stem cell transplantation.