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There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.
Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose stem cell group (1×10^6cells/kg per infusion) | Experimental | Peripheral intravenous infusion of low-dose stem cells |
|
| medium-high-dose stem cell group (3×10^6cells/kg per infusion) | Experimental | Peripheral intravenous infusion of medium-high-dose stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord-mesenchymal stem cells | Biological | Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Number of subjects surviving after one year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in liver function | The values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh | 1, 4, 8, 12, 24, and 48 weeks |
| Incidence of hepatic decompensation events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mengfan Ruan, MM | The General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110840 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34597754 | Result | Zhang L, Ma XJ, Fei YY, Han HT, Xu J, Cheng L, Li X. Stem cell therapy in liver regeneration: Focus on mesenchymal stem cells and induced pluripotent stem cells. Pharmacol Ther. 2022 Apr;232:108004. doi: 10.1016/j.pharmthera.2021.108004. Epub 2021 Sep 28. | |
| 33764490 | Result | Khan S, Khan RS, Newsome PN. Cell Therapy for Liver Disease: From Promise to Reality. Semin Liver Dis. 2020 Nov;40(4):411-426. doi: 10.1055/s-0040-1717096. Epub 2020 Dec 24. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion).
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|
Number of patients who developed gastrointestinal bleeding, ascites and hepatic encephalopathy |
| 1 year |
| 29425678 | Result | Alfaifi M, Eom YW, Newsome PN, Baik SK. Mesenchymal stromal cell therapy for liver diseases. J Hepatol. 2018 Jun;68(6):1272-1285. doi: 10.1016/j.jhep.2018.01.030. Epub 2018 Feb 7. |