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Recruiting Phase 2 NCT05224960

Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)

Trial Parameters

Condition Decompensated Cirrhosis
Sponsor Beijing 302 Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 140
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-06-27
Completion 2025-06-27
Interventions
UC-MSCsPlacebo(solution without UC-MSCs)

Brief Summary

Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.

Eligibility Criteria

Inclusion Criteria: 1. Willing to provide written informed consent; 2. Aged 18 to 75 years (including 18 and 75 years), male or female; 3. Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications); 4. The Model for End-stage Liver Disease (MELD) score 15 to 30 points. Exclusion Criteria: 1. Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit. 2. Uncontrolled severe infection within 2 weeks of screening. 3. Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those w

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