Autologous CD34+ and CD133+ stem cells transplantation in patients with end stage liver disease

Table 1 Clinical features of the studied groups n (%)

Variables	Treated group (n = 90)	Control group (n = 50)
Age (yr, mean ± SD)	50.27 ± 6.05	50.9 ± 7.23
Sex
Male	78 (86.7)	39 (78)
Female	12 (13.3)	11 (22)
Residence
Urban	30 (33.33)	20 (40)
Rural	60 (66.66)	30 (60)
Jaundice	36 (40)	21 (42)
Encephalopathy	21 (23.33)	15 (30)
Weight loss	57 (63.33)	29 (58)
Ascites and lower limb edema	78 (86.66)	41 (82)
Peripheral erythema	75 (83.33)	39 (78)
Bleeding tendency	48 (53.33)	26 (52)
Hematemesis	24 (26.66)	12 (24)
Quantitative HCV RNA PCR (IU/mL)	1 128 230-1 810 530	1 235 650-1 754 150

HCV: Hepatitis C virus; PCR: Polymerase chain reaction.

Table 2 Ultrasonographic features of the studied groups n (%)

Variables	Treated group (n = 90)	Control group (n = 50)
Liver size
Average	27 (30)	16 (32)
Shrunken	54 (60)	23 (46)
Enlarged	9 (10)	11 (22)
Liver texture
Cirrhotic	90 (100)	50 (100)
Focal lesions	0	0
Spleen
Average sized	24 (26.66)	12 (24)
Mild splenomegaly	48 (53.33)	29 (58)
Moderate splenomegaly	18 (20)	9 (18)
Huge splenomegaly	0	0
Splenectomy	0	0
Ascites
Absent	6 (6.7)	8 (16)
Mild	12 (13.3)	5 (10)
Moderate	63 (70)	32 (64)
Massive	9 (10)	5 (10)

Table 3 Biochemical changes in the studied groups (mean ± SD)

	Pre treatment	1st month	2nd month	3rd month	6th month
Bilirubin (mg%)
Patients	2.51 ± 1.94	2.75 ± 1.66	2.31 ± 1.33	2.34 ± 1.29	2.18 ± 1.28
Control	2.68 ± 1.49	2.80 ± 1.51	2.92 ± 1.71	3.41 ± 1.77	3.58 ± 1.56
			P < 0.001	P < 0.002	P < 0.003
Albumin (gm/dL)
Patients	2.61 ± 0.44	2.73 ± 0.62	2.83 ± 0.39	2.92 ± 0.33	2.94 ± 0.45
Control	2.69 ± 0.26	2.60 ± 0.30	2.54 ± 0.25	2.44 ± 0.35	2.10 ± 0.34
				P < 0.04	P < 0.001
PC (%)
Patients	46.2 ± 12.5	49.6 ± 12.5	55.0 ± 14.5	54.9 ± 12.9	56.1 ± 15.7
Control	45.1 ± 12.8	44.9 ± 13.1	42.2 ± 13.5	40.9 ± 14.1	35.8 ± 15.9
		P < 0.005	P < 0.005	P < 0.005	P < 0.005
AST (U/L)
Patients	78.2 ± 32.1	67.4 ± 25.2	68.0 ± 20.2	61.0 ± 18.7	69.0 ± 29.2
Control	75.4 ± 35.2	77.2 ± 30.1	72.1 ± 32.3	75.5 ± 33.3	80.2 ± 32.4
		P < 0.002	P < 0.002	P < 0.003	P < 0.003
ALT (U/L)
Patients	51.5 ± 25.5	45.7 ± 19.6	50.9 ± 27.7	42.8 ± 16.1	47.0 ± 21.3
Control	60.1 ± 20.4	62.5 ± 21.2	66.1 ± 25.1	63.5 ± 23.7	23.7 ± 22.1
		P < 0.001	P < 0.001	P < 0.01	P < 0.01

PC: Prothrombin concentration; AST: Aspartate transaminase; ALT: Alanine transaminase.

Table 4 Response rate of the treated group according to synthetic and biochemical liver functions n (%)

Marker	Responders				Stable				Non-responders				P value
	1st mo	2nd mo	3rd mo	6th mo	1st mo	2nd mo	3rd mo	6th mo	1st mo	2nd mo	3rd mo	6th mo
Bilirubin	24 (26.6)	30 (37.0)	33 (46.5)	39 (56.5)	0 (0)	9 (11.1)	9 (12.8 )	0 (0)	66 (73.3)	42 (51.9)	29 (40.8)	30 (43.5)	0.516
Albumin	57 (63.3)	45 (55.6)	42 (59.2)	40 (58.0)	3 (3.33)	9 (11.1)	9 (12.7)	8 (11.6)	30 (33.3)	27 (33.3)	20 (28.1)	21 (30.4)	0.069
PC	66 (73.3)	57 (70.4)	47 (66.2)	48 (65.6)	0 (0)	3 (3.6)	6 (8.5)	0 (0)	24 (26.6)	21 (25.8)	18 (25.4)	21 (30.4)	0.023
AST	57 (63.3)	48 (60.3)	47 (66.2)	39 (56.5)	3 (3.33)	0 (0)	0 (0)	0 (0)	30 (33.3)	33 (40.7)	24 (33.8 )	30 (43.5)	0.673
ALT	54 (60.0)	48 (59.2)	47 (66.2)	30 (43.5)	0 (0)	3 (3.7)	6 (8.5)	6 (8.7)	36 (40.0)	30 (37.1)	18 (25.3)	33 (47.8)	0.550

PC: Prothrombin concentration; AST: Aspartate transaminase; ALT: Alanine transaminase.

Table 5 Cross-table showing progress of hepatic coma and hematemesis after 1, 2, 3 and 6 mo n (%)

	Pretreatment (n = 90)		1 mo (n = 90)		2 mo (n = 81)		3 mo (n = 71)		6 mo (n = 69)
	No	Yes	No	Yes	No	Yes	No	Yes	No	Yes
Coma
Studied group	60 (66.7)	30 (33.3)	87 (96.7)	3 (3.3)	72 (89)	9 (11)	66 (92.9)	5 (7.1)	63 (91.3)	6 (8.7)
	50 patients		50 patients		44 patients		34 patients		26 patients
Control group	31 (62)	19 (38)	29 (48)	21 (42)	24 (54.5)	20 (45.5)	14 (41.2)	20 (58.8)	5 (19.2)	21 (80.7)
Hematemesis
Studied group	72 (80)	18 (20)	90 (100)	0 (0)	75 (92.6)	6 (7.4)	68 (95.8)	3 (4.2)	60 (87)	9 (13)
	50 patients		50 patients		44 patients		34 patients		26 patients
Control group	35 (70)	15 (30)	32 (64)	18 (36)	24 (54.5)	20 (54.5)	12 (35.3)	24 (70.6)	6 (23)	20 (77)

Table 6 Response rate of the treated group in relation to clinical features n (%)

Marker	Responders				Stable				Non-responders				P value
	1st mo	2nd mo	3rd mo	6th mo	1st mo	2nd mo	3rd mo	6th mo	1st mo	2nd mo	3rd mo	6th mo
Child-Pugh score	9 (10)	18 (22.2)	21 (29.6)	27 (39.1)	72 (80)	48 (59.3)	45 (63.4)	39 (56.2)	3 (10)	15 (18.5)	5 (7.0)	3 (4.4)	0.03
Performance score	18 (20)	27 (33.3)	42 (59.2)	42 (60.9)	51 (56)	36 (44.4)	18 (25.4)	18 (26.1)	21 (23.2)	18 (22.2)	11 (15.4)	9 (13)	0.02
Degree of ascites	33 (36)	42 (51.8)	44 (62.0)	45 (65.2)	48 (53)	24 (29.6)	21 (29.5)	24 (34.8)	9 (10)	15 (18.6)	6 (8.5)	0 (0)	0.02
Hepatitis C coma	27 (30)	24 (29.7)	24 (33.8)	24 (34.9)	63 (70)	54 (66.6)	47 (66.2)	42 (60.8)	0 (0)	3 (3.7)	0 (0)	3 (4.3)	0.001
Haematemesis	18 (20)	21 (25.9)	21 (29.6)	18 (26.1)	72 (80)	57 (70.4)	50 (70.4)	48 (69.6)	0 (0)	3 (3.7)	0 (0)	3 (4.3)	0.03

Table 7 Multivariate analysis of hepatitis C virus viral titer vs clinical features of the responding group

	Beta	T	P value
Child-Pugh score	27.44	1.65	0.03
Performance score	41.2	2.6	0.02
Degree of ascites	35.03	1.3	0.02
Hepatic coma	29.1	1.2	0.001
Haematemesis	26.8	1.4	0.03

Multivariate analysis showing no significant correlation between hepatitis C virus (HCV) viral titer and serum albumin, prothrombin concentration, Child score, performance score, ascites grade, or hematemesis. However, there was a significant inverse relation between serum bilirubin levels and HCV, which reached the highest significance in the 6th month after treatment (r = 0.56, P < 0.002).