Clinical trial NCT06167473: Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD
Official title: Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with End-stage Liver Diseases
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: 2023-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18-80 years old
2. End-stage liver disease
3. Sign 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: 1 year
Secondary outcomes:
measure: Changes in liver function
timeFrame: 1, 4, 8, 12, 24, and 48 weeks
measure: Incidence of hepatic decompensation events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Mengfan Ruan, MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.