Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1)

NCT05227846 | Unknown Phase 1

• 1 other identifier: MSC-DLC-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open label, dose escalation clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The purpose of this study is to assess the safety of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events Incidence of Adverse Events

  from baseline to 28th day

• 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. 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 28th day

Secondary Outcomes (13)

• Change in Model for End-Stage Liver Disease (MELD) score from baseline to 3 days, 7days, 14 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, and 24 months

  3 days, 14 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, and 24 months

• Incidence of each complication associated with decompensated cirrhosis

  up to 24 months

• liver transplant-free survival

  up to 24 months

• Incidence of liver failure

  up to 24 months

• plasma albumin (ALB)

  up to 24 months

Study Arms (1)

Human Umbilical Cord-derived Mesenchymal Stem Cells

EXPERIMENTAL

Standard of care (SOC) plus a dose-escalation with 4 cohorts with 3-6 subjects/cohort who receive doses of 5, 10，15 and 20 ×10E7 cells. Proceed from lower dose to next higher dose if no safety concerns for each cohort.

Biological: Human Umbilical Cord-derived Mesenchymal Stem Cells

Interventions

Human Umbilical Cord-derived Mesenchymal Stem Cells BIOLOGICAL

Human Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.

Human Umbilical Cord-derived Mesenchymal Stem Cells

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
• Vcanbio Cell and Gene Engineering Corp., Ltd.: collaborator

Study Sites (1)

Beijing 302 Hospital

Beijing, China

RECRUITING

Related Publications (2)

• Shi L, Zhang Z, Mei S, Wang Z, Xu Z, Yao W, Liu L, Yuan M, Pan Y, Zhu K, Liu K, Meng F, Sun J, Liu W, Xie X, Dong T, Huang L, Meng F, Fu JL, Li Y, Zhang C, Fan X, Shi M, Zhang Y, Li Y, Xie WF, Zhang P, Wang FS. Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights. Signal Transduct Target Ther. 2025 Jul 29;10(1):238. doi: 10.1038/s41392-025-02318-4.

  PMID: 40721581 DERIVED

• Wang Z, Li T, Zhang Z, Yuan M, Shi M, Wang FS, Linghu EQ, Shi L. Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol. BMJ Open. 2023 Dec 30;13(12):e078362. doi: 10.1136/bmjopen-2023-078362.

  PMID: 38159943 DERIVED

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: March 22, 2022
• Primary Completion: June 30, 2024
• Study Completion: March 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)