Safety and efficacy outcomes after intranasal administration of neural stem cells in cerebral palsy: a randomized phase 1/2 controlled trial

Table 4 Changes of scales from baseline to month 24 in the treatment group

	Baseline	1 M	3 M	6 M	24 M	P value
FMFS	24.00 ± 15.85	28.42 ± 16.57	29.33 ± 15.68	31.54 ± 17.93	36.56 ± 17.86*	.010*
SS	26.68 ± 18.65	30.58 ± 18.54	34.17 ± 17.40	32.82 ± 17.82*	39.00 ± 16.73**	.000**
LAS	29.36 ± 21.00	32.12 ± 20.65	33.46 ± 18.63	33.32 ± 19.87	39.23 ± 19.27	.205
EAS	29.29 ± 21.41	33.31 ± 21.21	36.92 ± 19.86*	33.86 ± 20.08*	39.14 ± 19.36*	.003*
GMFM-88-A (Lying and Rolling)	45.36 ± 11.53	47.77 ± 9.98	47.33 ± 10.33	48.29 ± 8.82	47.82 ± 9.91	.084
GMFM-88-B (Sitting)	39.29 ± 20.57	49.85 ± 19.27	52.58 ± 16.05	50.29 ± 19.08	53.36 ± 16.82	.040*
GMFM-88-C (Crawling and Kneeling)	19.79 ± 14.29	28.46 ± 14.56	31.33 ± 12.15	27.29 ± 13.76	35.18 ± 12.17	.014*
GMFM-88-D (Standing)	15.86 ± 10.33	22.85 ± 11.51*	25.92 ± 9.42*	23.14 ± 11.79	25.36 ± 10.39**	.001**
GMFM-88-E (Walking, Running and Jumping)	14.29 ± 13.60	21.77 ± 15.24**	25.75 ± 17.13**	26.07 ± 19.21**	31.18 ± 18.79**	.000**
GMFM-88-TOTAL	52.41 ± 24.44	66.66 ± 25.02	71.45 ± 22.29*	67.95 ± 24.72*	74.95 ± 23.84*	.001**
ADL	34.54 ± 20.90	45.85 ± 24.34**	52.08 ± 24.38**	50.82 ± 27.00**	61.68 ± 26.16**	.000**

Data are summarized as the mean ± SD (standard deviation). 1 M: 1 month after treatment; 3 M: 3 months after treatment; 6 M: 6 months after treatment; 24 M: 24 months after treatment; GMFM: Gross Motor Function Measure; ADL: Activity of Daily Living; FMFS: Fine Motor Function Scale; SS: Sociability Scale; LAS: Life Adaptability Scale; EAS: Expressive Ability Scale
*P < 0.05; **P < 0.01

ISSN: 1757-6512