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Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.
Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-infusion group | Experimental | Single peripheral venous infusion of stem cells |
|
| Double-infusion group | Experimental | Repeated peripheral venous infusion of stem cells within one month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord-mesenchymal stem cells | Biological | Umbilical cord mesenchymal stem cells injected through peripheral veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Child A | Patients with Child A | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver function parameters | 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 | 24 weeks |
| Incidence of hepatic decompensation events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingshun Qi, MD | The General Hospital of Northern Theater Command | Study Director |
| Wen Ning, 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 |
|---|---|---|---|
| 25154380 | Result | Volarevic V, Nurkovic J, Arsenijevic N, Stojkovic M. Concise review: Therapeutic potential of mesenchymal stem cells for the treatment of acute liver failure and cirrhosis. Stem Cells. 2014 Nov;32(11):2818-23. doi: 10.1002/stem.1818. | |
| 38179765 | Result | Wang J, Li Q, Li W, Mendez-Sanchez N, Liu X, Qi X. Stem Cell Therapy for Liver Diseases: Current Perspectives. Front Biosci (Landmark Ed). 2023 Dec 28;28(12):359. doi: 10.31083/j.fbl2812359. |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy |
| 24 weeks |
| Survival rate and liver transplant rate | Number of patients surviving and undergoing liver transplantation | 24 weeks |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |