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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 human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.
Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.
Thirty-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 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. 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 at weeks 4, 12, and 24 post-infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral veins infusion group | Experimental | Peripheral veins infusion of stem cells |
|
| Hepatic arterial infusion group | Experimental | Hepatic arterial infusion of stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of umbilical cord-mesenchymal stem cells through peripheral veins | Other | Umbilical cord-mesenchymal stem cells injected through peripheral veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Number of subjects surviving after 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Model for End-Stage Liver Disease (MELD) score | The Model for End-Stage Liver Disease (MELD) score ranges from 6 to 40, with higher values indicating more severe liver dysfunction and an increased risk of mortality. | 4, 12, and 24 weeks |
| Changes in Child-Pugh score |
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Inclusion Criteria:
18-80 years old
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End-stage liver disease
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Signed informed consent
Exclusion Criteria:
Tumours of the liver or other organs
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Liver transplantation recipients
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Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
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Other diseases that may seriously affect the survival
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Human immunodeficiency syndrome
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Interferon or glucocorticoid therapy within 1 year
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Treated for mental illness
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Participation in other clinical trials within 30 days
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Pregnant or breastfeeding subjects
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Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
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Other circumstances that are unsuitable for participation in this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi, MD | Contact | 18909881019 | xingshunqi@126.com | |
| Beilei Zhang, MM | Contact | 15191080726 | 15191080726@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingshun Qi, MD | The General Hospital of Northern Theater Command Study Director | Study Director |
| Beilei Zhang, MM | The General Hospital of Northern Theater Command Study Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command Recruiting | Shenyang | Liaoning | 110840 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19654548 | Background | Lyra AC, Soares MB, da Silva LF, Braga EL, Oliveira SA, Fortes MF, Silva AG, Brustolim D, Genser B, Dos Santos RR, Lyra LG. Infusion of autologous bone marrow mononuclear cells through hepatic artery results in a short-term improvement of liver function in patients with chronic liver disease: a pilot randomized controlled study. Eur J Gastroenterol Hepatol. 2010 Jan;22(1):33-42. doi: 10.1097/MEG.0b013e32832eb69a. | |
| 32977828 |
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| Infusion of umbilical cord-mesenchymal stem cells through hepatic artery | Other | Umbilical cord-mesenchymal stem cells injected through hepatic artery |
|
The Child-Pugh score is categorized into class A (5-6 points), class B (7-9 points), and class C (≥10 points), reflecting progressive liver disease severity. Higher Child-Pugh scores are associated not only with increased mortality risk but also with a significantly higher incidence of complications, such as gastrointestinal bleeding and infections. |
| 4, 12, and 24 weeks |
| Incidence of hepatic decompensation events | Number of patients who developed gastrointestinal bleeding, ascites, and hepatic encephalopathy | 4, 12, and 24 weeks |
| Background |
| Zhou GP, Jiang YZ, Sun LY, Zhu ZJ. Therapeutic effect and safety of stem cell therapy for chronic liver disease: a systematic review and meta-analysis of randomized controlled trials. Stem Cell Res Ther. 2020 Sep 25;11(1):419. doi: 10.1186/s13287-020-01935-w. |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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