Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial.
BACKGROUND
End-stage liver disease is a medical problem with high morbidity and mortality. We have investigated the feasibility, safety, and efficacy of using autologous mesenchymal stem cells (MSCs) as a treatment.


METHODS
Eight patients (four hepatitis B, one hepatitis C, one alcoholic, and two cryptogenic) with end-stage liver disease having Model for End-Stage Liver Disease score > or =10 were included. Autologous MSCs were taken from iliac crest. Approximately, 30-50 million MSCs were proliferated and injected into peripheral or the portal vein. Liver function and clinical features were evaluated at baseline and 1, 2, 4, 8, and 24 weeks after injection.


RESULTS
Treatment was well tolerated by all patients. Liver function improved as verified by the Model for End-Stage Liver Disease score, which decreased from 17.9+/-5.6 to 10.7+/-6.3 (P<0.05) and prothrombin complex from international normalized ratio 1.9+/-0.4 to 1.4+/-0.5 (P<0.05). Serum creatinine decreased from 114+/-35 to 80+/-18 micromol/l (P<0.05). Serum albumin changed from 30+/-5 to 33+/-5 g/l and bilirubin from 46+/-29 to 41+/-31 micromol/l. No adverse effects were noted.


CONCLUSIONS
Our data show that MSCs injection can be used for the treatment of end-stage liver disease with satisfactory tolerability. Furthermore, this treatment may improve clinical indices of liver function in end-stage liver disease.
Kharaziha
Pedram
P
Urology and Nephrology Research Center (UNRC), Karolinska Institutet, Stockholm, Sweden, Karolinska University Hospital Solna, Sweden.
Hellström
Per M
PM
Noorinayer
Babak
B
Farzaneh
Farivar
F
Aghajani
Katayoun
K
Jafari
Fereshteh
F
Telkabadi
Mohammad
M
Atashi
Amir
A
Honardoost
Maryam
M
Zali
Mohammad Reza
MR
Soleimani
Masoud
M
D000328:Adult; D000368:Aged; D002454:Cell Differentiation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D022781:Hepatocytes / Q000166:cytology; D006801:Humans; D008099:Liver / Q000503:physiopathology*; D008103:Liver Cirrhosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology; D008875:Middle Aged; D020858:Tissue and Organ Harvesting / Q000379:methods; D016896:Treatment Outcome