Clinical trial NCT06242405: Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD
Official title: Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with End-stage Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Liver DIsease
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: 2024-02-05
Enrollment: 92
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 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.

Detailed description: 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.

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: Proportion of patients with Child A
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in liver function parameters
timeFrame: 24 weeks
measure: Incidence of hepatic decompensation events
timeFrame: 24 weeks
measure: Survival rate and liver transplant rate
timeFrame: 24 weeks
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: Xingshun Qi, MD
role: STUDY_DIRECTOR
affiliation: The General Hospital of Northern Theater Command
name: Wen Ning, MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.