Human Umbilical Cord-mesenchymal Stem Cells Via Different Transplantation Routes in ESLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins, Infusion of umbilical cord-mesenchymal stem cells through hepatic artery.
- Who it may be relevant to
- Registry conditions: End-Stage Liver Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
Overview
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.
Detailed description
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.
Interventions
- Other Infusion of umbilical cord-mesenchymal stem cells through peripheral veins
Umbilical cord-mesenchymal stem cells injected through peripheral veins - Other Infusion of umbilical cord-mesenchymal stem cells through hepatic artery
Umbilical cord-mesenchymal stem cells injected through hepatic artery
Primary outcome measures
- Survival rate [Time frame: 24 weeks]
Secondary outcome measures (3)
- Changes in Model for End-Stage Liver Disease (MELD) score [Time frame: 4, 12, and 24 weeks]
- Changes in Child-Pugh score [Time frame: 4, 12, and 24 weeks]
- Incidence of hepatic decompensation events [Time frame: 4, 12, and 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- General Hospital of Northern Theater Command Recruiting — Shenyang
Publications
- 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.0 PMID 19654548
- 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. PMID 32977828
Identifiers
NCT: NCT06984497 · XHNKKY-DRSC