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Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I–II clinical trial

Kharaziha, Pedrama b; Hellström, Per M.f; Noorinayer, Babakb; Farzaneh, Farivard; Aghajani, Katayounb; Jafari, Fereshtehb; Telkabadi, Mohammadb; Atashi, Amird e; Honardoost, Maryamd; Zali, Mohammad Rezac; Soleimani, Masoude

European Journal of Gastroenterology & Hepatology: October 2009 - Volume 21 - Issue 10 - p 1199-1205
doi: 10.1097/MEG.0b013e32832a1f6c
Original Articles: Liver Function

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 μmol/l (P<0.05). Serum albumin changed from 30±5 to 33±5 g/l and bilirubin from 46±29 to 41±31 μmol/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.

aUrology and Nephrology Research Center (UNRC)

bTaleghani Hospital

cResearch Center of Gastroenterology and Liver Disease, Shahid Beheshti University of MC

dCell Biology Department, Stem Cell Technology Company

eDepartment of Hematology, Faculty of Medical Sciences, Tarbiat Modarres University, Tehran, Iran

fDepartment of Medicine, Gastroenterology Unit, Karolinska Institutet, Stockholm, Sweden, Karolinska University Hospital Solna, Sweden

Correspondence to Professor Per M. Hellström, MD, PhD, Gastrocentre Medicine, Karolinska University Hospital, Solna, SE-171 76 Stockholm, Sweden

Tel: +46 8 5177 3177; fax: +46 8 5177 1100; e-mail: Per.Hellstrom@ki.se

Received 8 December 2008 Accepted 29 January 2009

© 2009 Lippincott Williams & Wilkins, Inc.