Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD

General Hospital of Shenyang Military Region92 enrolled

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 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

End-Stage Liver DIsease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients with Child A

Patients with Child A

Time frame: 24 weeks

Secondary Outcomes

Change in liver function parameters

Values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh

Time frame: 24 weeks

Incidence of hepatic decompensation events

Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy

Time frame: 24 weeks

Survival rate and liver transplant rate

Number of patients surviving and undergoing liver transplantation

Time frame: 24 weeks

Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts