Objective To evaluate the
efficacy and long-term
safety of autologous
bone marrow stem cells (ABMSC)
transplantation in
patients with
hepatitis B virus (HBV)-associated decompensated
liver cirrhosis .
Methods This was an open-label,prospective
matched case-control study .Thirty
patients with HBV-associated decompensated
liver cirrhosis hospitalized at the Third Affiliated
Hospital of
Sun Yat-Sen
University from January 2005 to June 2010 were collected and infused with
stem cells (
stem cell group). Another thirty
patients in
control group were matched according to baseline characteristics and treated with standard
medicine therapy .The
patients in
stem cell group were treated with
stem cells infusion by
hepatic artery or
portal vein based on standard
medicine therapy .All the
patients were followed up for 5 to 10 years after
surgery . Biochemical
indicators were evaluated within the first 48 weeks after
transplantation .The
complications of
cirrhosis and the
cumulative incidence rate of
hepatocellular carcinoma (HCC)were observed.Measurement data with
normal distribution were analyzed by t test. Measurement data with non-
normal distribution were compared by Mann-Whitney test.Count data were compared by χ2 test.The
cumulative incidence rate of HCC development was compared by
Kaplan-Meier analysis .Results The
bone marrow aspiration and
transplantation surgery were well tolerated in all
patients in
stem cell group.No complication related to
stem cell transplantation therapy was observed. The levels of
alanine aminotransferase (ALT),
aspartate aminotransferase (AST),total
bilirubin (TBil) and
prothrombin time (PT)decreased,
albumin level increased,while model for end-stage
liver disease (MELD)scores decreased in both groups
after treatment .
Serum albumin level in
stem cell group increased and ALT level decreased markedly at week 4,compared with that in
control group at week 4(Z=2.188,P=0.029,Z=3.296,P=0.001,respectively).In
stem cell group,21
patients received
stem cells transplantation by
hepatic artery and 9
patients by
portal vein .Biochemical
indicators were improved in all
patients compared to baseline.However,there was no statistically significant differences between
hepatic artery group and
portal vein group.The median follow-up
time was 6 years.Two
patients in
stem cell group and 1
patient in
control group died(χ2=0.351,P=0.554).Six
patients in
stem cell group (20.0%)and 11
patients (36.7%)in
control group developed HCC.There was no significant differences in the
cumulative incidence rate of HCC between two groups(χ2= 0.148,P= 0.701).
Hepatorenal syndrome did not development in either group.There were no statistically significant differences in the rates of
complications including spontaneous
peritonitis ,
hepatic encephalopathy and
gastrointestinal hemorrhage between two groups after 5 to 10 years of follow-up(χ2=0.162,P=0.688,χ2=1.071,P=0.301,χ2=1.071,P=0.301,respectively).Conclusion ABMSC
transplantation in
patients with HBV-associated decompensated
liver cirrhosis improves
liver function transiently and has long-term
safety .