Phase 1 human trial of autologous bone marrow-hematopoietic stem cell transplantation in patients with decompensated cirrhosis

Table 1 Baseline characteristics of the patients

	Patient 1	Patient 2	Patient 3	Patient 4
Age (yr)	40	53	45	53
Gender	Male	Female	Male	Female
Etiology of cirrhosis	Hepatitis B	PBC	Cryptogenic	AIH
Medications	Lamivudine, Spironolactone, Furosmide	UDCA, Spironolactone, Furosmide	Spironolactone, Furosmide	Spironolactone, Furosmide

UDCA: Ursodeoxy-cholic acid; AIH: Autoimmune hepatitis; PBC: Primary biliary cirrhosis.

Table 2 Paraclinical data of the patients at baseline and at the end of follow up

	Patient 1		Patient 2		Patient 3		Patient 4
	Baseline	mo 6	Baseline	mo 6	Baseline	mo 6	Baseline	mo 61
Edema	2+	None	2+	2+	1+	1+	2+	–
Ascites	Moderate	None	Moderate	Moderate	Moderate	Moderate	Severe	–
Serum albumin (g/dL)	3.8	4.2	2.9	3.1	2.5	2.8	2.6	–
PT (seconds)	14	14.6	20.7	17	18.7	16.7	19.5	–
INR	1.2	1.3	2.2	1.8	1.9	1.6	2	–
Cr (mg/dL)	1.2	0.83	0.95	1.8	0.72	0.8	1.37	–
Total bilirubin (mg/dL)	1.2	1.87	3.31	5	2.37	2.02	19.85	–
Direct bilirubin (mg/dL)	0.4	0.43	2.03	2.8	0.66	0.82	13.82	–
AST (IU/mL)	43	52	52	75	62	37	2202	–
ALT (IU/mL)	31	34	23	30	30	15	2163	–
AFP (mcg/L)	4.7	3.7	3.48	5.5	1.7		3.8	–
MELD score	11	12	20	25	17	14	29	–
Liver volume (cm3)	1205	1180	960	NA	896	474	1159	–

¹Since patient 4 died two weeks after undergoing the procedure. There is no data of her follow up on mo 6;

²Serum aminotransferases of the patient 4 was less than 3 times of upper limit of normal at screening. PT: Prothrombin time; INR: International normalized ratio; Cr: Serum creatinine; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; AFP: Alpha fetoprotein; MELD: Model for end stage liver disease. NA: not available.