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

NCT05224960 | Recruiting Phase 2

• 1 other identifier: MSC-DLC-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day

  The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology.

  Baseline, 28th day

Secondary Outcomes (23)

• Change in MELD score from baseline to 24 months

  up to 24 months

• Incidence of each complication associated with decompensated cirrhosis

  up to 24 months

• Liver transplant-free survival

  month 12 and 24

• Incidence of liver failure

  month 12 and 24

• plasma albumin (ALB)

  up to 24 months

Study Arms (2)

Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)

EXPERIMENTAL

UC-MSCs plus standard of care (SOC).

Biological: UC-MSCs

Placebo

PLACEBO COMPARATOR

Placebo plus SOC.

Biological: Placebo(solution without UC-MSCs)

Interventions

UC-MSCs BIOLOGICAL

3 doses of UC-MSCs intravenously at day 1, day 8, day 15.

Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)

Placebo(solution without UC-MSCs) BIOLOGICAL

3 doses of placebo intravenously at day 1, day 8, day 15.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide written informed consent;
• Aged 18 to 75 years (including 18 and 75 years), male or female;
• 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);
• The Model for End-stage Liver Disease (MELD) score 15 to 30 points.

You may not qualify if:

• Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.
• Uncontrolled severe infection within 2 weeks of screening.
• Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
• Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA\< detection limit without any antiviral treatment).
• Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
• Significant renal insufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level \< 125 mmol/L); Severe leukopenia (white blood cell count \< 1 × 10E9/L).
• Patients with biliary obstruction, or portal vein spongiosis.
• Patients with surgical history such as splenic cut-off flow.
• Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and/or carcinoma in situ who had received curative treatment and curative resection.
• Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.
• Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
• Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.
• Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.
• Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.
• History of pulmonary embolism.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Chinese PLA General Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator
• LanZhou University: collaborator
• Jin Yin-tan Hospital: collaborator
• Hainan Hospital of Chinese PLA General Hospital: collaborator
• Vcanbio Cell and Gene Engineering Corp., Ltd.: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Xinjiang Kashi Area Number 1 Hospital: collaborator

Study Sites (7)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Hainan hospital of Chinese PLA General Hospital

Sanya, Hainan, China

RECRUITING

Jin Yin-tan Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Xinjiang Kashi Area Number 1 Hospital

Kashgar, Xinjiang, China

NOT YET RECRUITING

Beijing 302 Hospital

Beijing, China

RECRUITING

Study Officials

• Fu-Sheng Wang, MD, PhD

  Beijing 302 Hospital

  STUDY CHAIR

Central Study Contacts

Lei Shi, MD,PhD

CONTACT

86-10-66949623; shilei302@126.com

Fu-Sheng Wang, MD,PhD

CONTACT

86-10-66933332; fswang302@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Model Details: Randomized, double-blind, placebo-controlled, multicenter study

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 4, 2022
• Study Start: June 27, 2024
• Primary Completion: June 27, 2025
• Study Completion (Estimated): June 20, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)