Safety and efficiency of Wharton’s Jelly-derived mesenchymal stem cell administration in patients with traumatic brain injury: First results of a phase I study

Table 1 Study group characteristics

Characteristics		n	%
Age (yr)	21	1	16.7
	22	1	16.7
	25	2	33.3
	26	1	16.7
	27	1	16.7
Sex	Female	2	33.3
	Male	4	66.7
Cause of spinal cord injury	Traffic accident	6	100.0
Comorbidity	None	6	100.0
Treatments before transplantation	Non-surgical	2	33.3
	Decompressive craniectomy	1	16.7
	Acute subdural hematoma evacuation and ventriculoperitoneal shunt	1	16.7
	Decompressive craniectomy and ventriculoperitoneal shunt	1	16.7
	Ventriculoperitoneal shunt	1	16.7
Duration between spinal cord injury and first transplantation	6 months	1	16.7
	18 months	1	16.7
	22 months	1	16.7
	24 months	2	33.3
	48 months	1	16.7

Table 2 Administration schedule

Date	Route	WJ-MSCs
Round 1
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)
Round 2 (2nd wk)
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)
Round 3 (1st month)
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)
Round 4 (2nd month)
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)
Round 5 (3rd month)
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)
Round 6 (4th month)
	I.t.	1 × 106/kg (3 mL in total)
	I.v.	1 × 106/kg (30 mL in total)
	I.m.	1 × 106/kg (20 mL in total)

I.t.: Intrathecal; I.v.: Intravenous; I.m.: Intramuscular; WJ-MSCs: Wharton’s Jelly-derived mesenchymal stem cells.

Table 3 Friedman test results of the changes observed in the Functional Independence Measure Motor Score values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	13.17	0.41	2.67	14.310	5	0.014
Postoperative 1st wk	6	13.17	0.41	2.67
Postoperative 1st month	6	13.33	0.82	2.92
Postoperative 2nd month	6	14.17	1.60	4.08
Postoperative 4th month	6	14.33	1.97	4.33
Postoperative 1st yr	6	14.33	1.97	4.33

Table 4 Functional Independence Measure Motor Score values of each patient

	FIM Scale, Motor Score: Self-care/Sphincter Control/Transfers/Locomotion
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	13	13	13	15	15	15
Patient 2	14	14	15	17	18	18
Patient 3	13	13	13	13	13	13
Patient 4	13	13	13	14	14	14
Patient 5	13	13	13	13	13	13
Patient 6	13	13	13	13	13	13

FIM: Functional Independence Measure.

Table 5 Friedman test results of the changes observed in the Functional Independence Measure Cognitive Score values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	5.67	1.63	1.58	26.160	5	0.000
Postoperative 1st wk	6	6.50	1.76	2.08
Postoperative 1st month	6	7.67	2.42	2.92
Postoperative 2nd month	6	8.83	3.49	3.75
Postoperative 6th month	6	11.00	4.43	4.92
Postoperative 1st yr	6	11.83	3.97	5.75

Table 6 Functional Independence Measure Cognitive Score values of each patient

	FIM Scale, Cognitive Score: Communication/Social Cognition (TS:35)
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	5	5	8	9	11	11
Patient 2	9	9	12	15	17	18
Patient 3	5	5	6	6	8	8
Patient 4	5	7	7	9	15	15
Patient 5	5	8	8	9	10	11
Patient 6	5	5	5	5	5	8

FIM: Functional Independence Measure.

Table 7 Friedman test results of the changes observed in the Modified Ashworth Score right values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	19.83	4.58	5.58	28.641	5	0.000
Postoperative 1st wk	6	19.50	4.46	5.33
Postoperative 1st month	6	17.33	4.68	4.00
Postoperative 2nd month	6	16.17	5.35	2.83
Postoperative 4th month	6	15.17	4.99	1.83
Postoperative 1st yr	6	13.83	4.83	1.42

Table 8 Modified Ashworth Score right values of each patient

	Modified Ashworth Score (right)
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	19	19	16	14	12	12
Patient 2	20	20	16	15	14	14
Patient 3	20	20	18	17	16	11
Patient 4	26	26	24	24	22	22
Patient 5	12	12	10	8	8	8
Patient 6	22	20	20	19	19	16

Table 9 Friedman test results of the changes observed in the Modified Ashworth Score left values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	18.83	5.04	5.58	28.462	5	0.000
Postoperative 1st wk	6	18.50	4.85	5.25
Postoperative 1st month	6	16.33	4.68	3.83
Postoperative 2nd month	6	15.83	5.04	3.25
Postoperative 4th month	6	14.33	4.18	1.83
Postoperative 1st yr	6	13.00	4.60	1.25

Table 10 Modified Ashworth Score left values of each patient

	Modified Ashworth Score (left)
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	19	19	16	16	14	12
Patient 2	20	20	15	14	13	13
Patient 3	20	20	18	17	16	11
Patient 4	23	23	21	21	19	19
Patient 5	9	9	8	7	7	6
Patient 6	22	20	20	20	17	17

Table 11 Friedman test results of the changes observed in the Medical Research Council muscle strength scale right values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	3.33	1.86	2.58	13.214	5	0.021
Postoperative 1st wk	6	3.33	1.86	2.58
Postoperative 1st month	6	3.67	1.51	3.33
Postoperative 2nd month	6	4.00	1.10	4.00
Postoperative 4th month	6	4.17	0.98	4.25
Postoperative 1st yr	6	4.17	0.98	4.25

Table 12 Medical Research Council muscle strength scale right values of each patient

	MRC muscle strength scale (right)
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	2	2	2	3	3	3
Patient 2	2	2	3	3	3	3
Patient 3	5	5	5	5	5	5
Patient 4	1	1	2	3	4	4
Patient 5	5	5	5	5	5	5
Patient 6	5	5	5	5	5	5

MRC: Medical Research Council.

Table 13 Friedman test results of the changes observed in the Medical Research Council muscle strength scale left values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	3.33	1.86	2.58	13.506	5	0.019
Postoperative 1st wk	6	3.33	1.86	2.58
Postoperative 1st month	6	3.67	1.51	3.25
Postoperative 2nd month	6	4.00	1.10	4.08
Postoperative 4th month	6	4.00	1.10	4.08
Postoperative 1st yr	6	4.17	0.98	4.42

Table 14 Medical Research Council muscle strength scale left values of each patient

	MRC muscle strength scale (left)
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	2	2	2	3	3	3
Patient 2	2	2	3	3	3	4
Patient 3	5	5	5	5	5	5
Patient 4	1	1	2	3	3	3
Patient 5	5	5	5	5	5	5
Patient 6	5	5	5	5	5	5

MRC: Medical Research Council.

Table 15 Friedman test results of the changes observed in the Karnofsky performance scale values of the patients before and after the intervention

	n	Mean	SD	Mean rank	χ2	df	P value
Preoperative	6	15.00	5.48	1.92	27.557	5	0.000
Postoperative 1st wk	6	15.00	5.48	1.92
Postoperative 1st month	6	21.67	11.69	2.92
Postoperative 2nd month	6	23.33	12.11	3.25
Postoperative 4th month	6	33.33	12.11	5.33
Postoperative 1st yr	6	36.67	15.06	5.67

Table 16 Karnofsky performance scale values of each patient

	Karnofsky performance scale
	Pre-test	Post-test (1st wk)	Post-test (1st month)	Post-test (2nd month)	Post-test (4th month)	Post-test (12th month)
Patient 1	10	10	20	20	30	30
Patient 2	20	20	40	40	50	50
Patient 3	20	20	20	30	40	50
Patient 4	20	20	30	30	40	50
Patient 5	10	10	10	10	20	20
Patient 6	10	10	10	10	20	20