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 >= 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 mu mol/l (P<0.05). Serum albumin changed from 30 +/- 5 to 33 +/- 5 g/l and bilirubin from 46 +/- 29 to 41 +/- 31 mu mol/l. No adverse effects were noted. Conclusion 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. Eur J Gastroenterol Hepatol 21:1199-1205 (C) 2009 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.