Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic stroke

Table 1 Characteristics of intracerebral haemorrhage patients and infuses for autologous bone marrow-derived mesenchymal stem cell therapy

Patients	Sex/agein years	Location of haemorrhage	CT readout (cm)	Hemorrhage volume (mL)	MSC passage numbers	Viability (%)	MSC(× 107)	MSC/kg (× 105)
UPN02	F/50	Basal ganglia, left	4.4 × 5.8 × 5.9	75	4, 7	96.8	3.1	5.44
					3-5	92.1	3.2	5.61
					3-6	92.6	3.1	5.44
UPN08	F/48	Basal ganglia, left	4.0 × 2.0 × 3.0	12	3, 4	95.8	1.43	2.65
					3, 4	96.5	1.43	2.65
UPN09	M/56	Basal ganglia, right	6.5 × 5.0 × 4.0	65	3-8	98.5	7.6	13.1
					2-6	96.8	4	6.84
UPN10	F/55	Frontal lobe, right	5.6 × 4.5 × 5.0	63	1-6	88.5	5.5	13.1
					1-6	98	5.6	12.4
UPN11	M/55	Basal ganglia, left	2.4 × 5.0 × 3.5	21	1-6	90.5	5.4	9
					1-7	99	8.4	14.5
UPN05	F/59	Basal ganglia, left	6.0 × 4.0 × 4.0	48
UPN06	M/56	Basal ganglia, frontoparietal temporal lobe, right	7.3 × 3.5 × 5.0	64
UPN07	M/41	Basal ganglia, right	4.3 × 6.4 × 5.0	69
UPN12	M/50	Basal ganglia,	NA	55
		putaminal, right

MSC: Mesenchymal stem cell; CT: Computed tomography; NA: Not available.

Table 2 Modified Barthel indices of the treatment group (n = 5) having mesenchymal stem cell therapy at the 1^st, 12^th, 16^th, 24^th, 36^th and 60^th week upon completion of the study

Study duration (wk)	Modified barthel indices					P value
	UPN02	UPN08	UPN09	UPN10	UPN11
1st	19	66	0	4	69
12th	19	73	0	5	70	0.12
16th	30	76	0	5	77	0.03
24th	32	76	0	5	77	0.03
36th	32	78	1	6	77	0.02
60th	32	78	1	-	77	0.03

Data derived from different time points were compared to the baseline values established at the first week of the study.

Table 3 Functional independence measure of the treatment group (n = 5) having mesenchymal stem cell therapy at the 1^st, 12^th, 16^th, 24^th, 36^th and 60^th week upon completion of the study

Study duration (wk)	Scores of functional independence measure					P value
	UPN02	UPN08	UPN09	UPN10	UPN11
1st	36	72	20	83	70
12th	35	73	21	88	74	0.07
16th	40	79	21	89	80	0.01
24th	41	85	21	89	84	0.02
36th	44	87	22	102	84	0.01
60th	42	88	22	-	85	0.03

Data derived from different time points were compared to the baseline values established at the first week of the study.

Table 4 Scores of extended Glasgow Outcome Scale of the treatment group (n = 5) having mesenchymal stem cell therapy at the 1^st, 12^th, 16^th, 24^th, 36^th and 60^th week upon completion of the study

Study duration (wk)	Scores of extended glasgow outcome scale					P value
	UPN02	UPN08	UPN09	UPN10	UPN11
1st	3	4	3	3	4
12th	3	4	3	3	4	1
16th	3	4	3	3	4	1
24th	3	4	3	3	5	0.19
36th	3	5	3	3	5	0.09
60th	4	6	3	-	5	0.05

Data derived from different time points were compared to the baseline values established at the first week of the study.