Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I–II clinical trial
Abstract
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. 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.
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In a clinical trial using BM-MSCs to treat LC, 10 of the 20 patients died during the cell-preparing process, before the initiation of treatment.
“In a clinical trial using BM-MSCs to treat LC, 10 of the 20 patients died during the cell-preparing process, before the initiation of treatment [304].”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [304]
In a Phase I-II study, autologous BM-MSCs induced to undergo partial differentiation into HLCs before injection resulted in significant improvements in MELD score, INR, and serum creatinine levels at 24 weeks.
“In a Phase I-II study, autologous BM-MSCs were induced to undergo partial differentiation into HLCs before injection, and significant improvements in MELD score, INR, and serum creatinine levels were observed at 24 weeks [304].”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [304]
Portal vein injection may exacerbate portal hypertension, elevating the risk of hemorrhage, and is not suitable for patients with or at risk of portal vein thrombosis.
“Also, portal vein injection may exacerbate portal hypertension, elevating the risk of hemorrhage, thus not suitable for patients with or at risk of portal vein thrombosis [304].”
From Mechanisms, efficacy, and future perspectives of cellular-based therapies for liver fibrosis/cirrhosis: focusing on mesenchymal stromal cells (2025) · cites this paper as [304]
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“Also, portal vein injection may exacerbate portal hypertension, elevating the risk of hemorrhage, thus not suitable for patients with or at risk of portal vein thrombosis [304].”
Influential
- Authors
- Kharaziha, P., Hellström, P. M., Noorinayer, B., Farzaneh, F., Aghajani, K., Jafari, F., Telkabadi, M., Atashi, A., Honardoost, M., Zali, M. R., & Soleimani, M.
- Affiliations
- Karolinska University Hospital (SE)
- Taleghani General Hospital (IR)
- Tarbiat Modares University (IR)
- Corresponding author
- Hellström, Per M.
- ORCID
- Venue
- European Journal of Gastroenterology & Hepatology
- Published
- 2009-10
- Volume
- 21
- Issue
- 10
- Pages
- 1199-1205
- ISSN
- 0954-691X (ISSN-L)
- OpenAlex
- W1979037078
- Cited by
- 492
- References
- 0
- Citations by year
- 2026: 6 · 2025: 16 · 2024: 18 · 2023: 23 · 2022: 35 · 2021: 27 · 2020: 43 · 2019: 32 · 2018: 28 · 2017: 28 · 2016: 39 · 2015: 44 · 2014: 40 · 2013: 33 · 2012: 36
- FWCI
- 12.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Gastroenterology & Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- liver cirrhosis, autologous mesenchymal stem cells, end-stage liver disease, stem cell injection, portal vein injection, iliac crest, liver function, MELD score, prothrombin time, serum albumin, serum creatinine, bilirubin, safety and tolerability
- MeSH terms
- Adult, Aged, Cell Differentiation, Feasibility Studies, Female, Follow-Up Studies, Humans, Liver, Liver Cirrhosis, Male, Middle Aged, Treatment Outcome, Tissue and Organ Harvesting, Hepatocytes, Mesenchymal Stem Cell Transplantation, Mesenchymal Stem Cells
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