Both authors contributed equally to this study.
Cirrhosis and Liver Failure
Histological improvement following administration of autologous bone marrow-derived mesenchymal stem cells for alcoholic cirrhosis: a pilot study
Version of Record online: 19 JUN 2013
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Volume 34, Issue 1, pages 33–41, January 2014
How to Cite
Liver Int. 2014: 34:33–41
Clinical trial. gov: NCT01741090. Clinical research information service (CRIS): KCT0000266.
- Issue online: 10 DEC 2013
- Version of Record online: 19 JUN 2013
- Accepted manuscript online: 15 MAY 2013 11:08AM EST
- Manuscript Accepted: 11 MAY 2013
- Manuscript Received: 25 SEP 2012
- Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea. Grant Number: A102065
- bone marrow-derived mesenchymal stem cell;
- hepatic fibrosis;
- liver function;
- portal hypertension
In experimental models, bone marrow-derived mesenchymal stem cells (BM-MSCs) have the capacity to differentiate into hepatocytes and exhibit antifibrotic effects. However, there have been no studies in humans with alcoholic cirrhosis.
The aim of this study was to elucidate the antifibrotic effect of BM-MSCs in patients with alcoholic cirrhosis, as a phase II clinical trial.
Twelve patients (11 males, 1 female) with baseline biopsy-proven alcoholic cirrhosis who had been alcohol free for at least 6 months were enrolled. BM-MSCs were isolated from each patient's BM and amplified for 1 month, and 5 × 107 cells were then injected twice, at weeks 4 and 8, through the hepatic artery. One patient was withdrawn because of ingestion of alcohol. Finally, 11 patients completed the follow-up biopsy and laboratory tests at 12 weeks after the second injection. The primary outcome was improvement in the patients’ histological features.
According to the Laennec fibrosis system, histological improvement was observed in 6 of 11 patients (54.5%). The Child-Pugh score improved in ten patients (90.9%) and the levels of transforming growth factor-β1, type 1 collagen and α-smooth muscle actin significantly decreased (as assessed by real-time reverse transcriptase polymerase chain reaction) after BM-MSCs therapy (P < 0.05). No significant complications or side effects were observed during this study.
Bone marrow-derived mesenchymal stem cells therapy in alcoholic cirrhosis induces a histological and quantitative improvement of hepatic fibrosis.