Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis

NCT05121870 | Unknown Phase 2

• 1 other identifier: NCRC-ID202105
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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 24th week

  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. The MELD score is calculated by the formula: R = 9.6 × ln (creatinine mg/dl) + 3.8 × ln (bilirubin mg/dl) + 11.2 × ln (INR) + 6.4 × etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).

  at 24th week

Secondary Outcomes (13)

• Change in MELD score from baseline to 48 weeks

  up to 48 weeks

• Incidence of each complication associated with decompensated cirrhosis

  up to 48 weeks

• liver transplant-free survival

  up to 48 weeks

• Incidence of liver failure

  up to 48 weeks

• plasma albumin (ALB)

  up to 48 weeks

Study Arms (2)

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

EXPERIMENTAL

standard of care (SOC) plus UC-MSCs

Biological: UC-MSCs

Placebo

PLACEBO COMPARATOR

SOC plus placebo.

Biological: Saline containing 1% Human serum albumin（solution without UC-MSCs）

Interventions

UC-MSCs BIOLOGICAL

3 does of UC-MSCs(6.0×10E7cells per time) intravenously at week 0, week 4, week 8.

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

Saline containing 1% Human serum albumin（solution without UC-MSCs） BIOLOGICAL

3 does of placebo intravenously at week 0, week 4, week 8.

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);
• Child-Turcotte-Pugh (CTP) score 7 to 12 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.
• Hepatitis B virus (HBV) DNA ≥ detection limit at the time 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.
• 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.
• Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
• Severe jaundice (serum total bilirubin level ≥ 170μmol/L); 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, hepatic vein, portal vein, splenic vein thrombosis and portal vein spongiosis.
• Patients with surgical history such as splenic cut-off flow and portal body shunt.
• Patients with confirmed or suspected malignancies.
• 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.
• HIV seropositivity.
• Those who have received blood transfusion or other blood products within 1 month prior to screening visit.
• Pregnancy, lactation or with recent fertility plan.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Shanghai Changzheng Hospital: collaborator
• LanZhou University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Chinese PLA General Hospital: collaborator
• Vcanbio Cell and Gene Engineering Corp., Ltd.: collaborator

Study Sites (5)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

Hainan hospital of Chinese PLA General Hospital

Sanya, Hainan, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, 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: October 17, 2021
• First Posted: November 16, 2021
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (5)