Clinical trial NCT06984497: Human Umbilical Cord-mesenchymal Stem Cells Via Different Transplantation Routes in ESLD
Official title: Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Liver Diseases
Keywords: cirrhosis
end-stage liver diseases
umbilical cord-mesenchymal stem cells
randomized controlled trial
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 18-80 years old

   -
2. End-stage liver disease

   -
3. Signed informed consent

Exclusion Criteria:

1. Tumours of the liver or other organs

   -
2. Liver transplantation recipients

   -
3. 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

   -
4. Other diseases that may seriously affect the survival

   -
5. Human immunodeficiency syndrome

   -
6. Interferon or glucocorticoid therapy within 1 year

   -
7. Treated for mental illness

   -
8. Participation in other clinical trials within 30 days

   -
9. Pregnant or breastfeeding subjects

   -
10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies

    -
11. Other circumstances that are unsuitable for participation in this study

Primary outcomes:
measure: Survival rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Model for End-Stage Liver Disease (MELD) score
timeFrame: 4, 12, and 24 weeks
measure: Changes in Child-Pugh score
timeFrame: 4, 12, and 24 weeks
measure: Incidence of hepatic decompensation events
timeFrame: 4, 12, and 24 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command Recruiting
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command Study Director
name: Xingshun Qi, MD
role: STUDY_DIRECTOR
affiliation: The General Hospital of Northern Theater Command Study Director
name: Beilei Zhang, MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.