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

NCT05984303 | Unknown Phase 1

• 1 other identifier: MSC-DLC-1b
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (4)

• Incidence of Adverse Events

  from baseline to 28th day

• incidence of dose-limiting toxicity-related adverse events

  from baseline to 28th day

• maximum tolerated dose

  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, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months

  3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 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 multiple administration and dose-escalasion with 2 cohorts with 3 subjects/cohort who receive doses of 1 and 2 ×10E8 cells. Each person received 3 infusions, 1 week apart, Proceed from lower dose to 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:

• Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening, or 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.
• Hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening, or patients with hepatitis C virus-related decompensated liver cirrhosis not more than 12 months on antiviral therapy.
• Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
• Patients with biliary obstruction, or portal patients with vein spongiosis.
• Patients are known with other malignancies within 5 years prior to the signing of ICF, except have had curative therapy of Basal Cell Cancer, Squamous Cell Carcinoma and/or radical resection of Carcinoma in Situ.
• Known to have had other malignancies within 5 years prior to signing the informed consent, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ with curable resection.
• Patients with history of organ transplantation.
• Patients with severe heart, lung, kidney and blood system diseases.
• Patients with drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
• Patients with history of immunodeficiency disease, including a positive test result for human immunodeficiency virus (HIV) antibodies, or other acquired or congenital immunodeficiency diseases;
• Pregnant or lactating female. Fertile patients who were unable or unwilling to use effective non-pharmaceutical contraception during the trial and within 6 months after the end of the trial.
• Patients who had cardiovascular and cerebrovascular events (such as Unstable Angina, Brain Hemorrhage, severe Ischemic Infarction) within 3 months before the first dose；Patients who had Myocardial Infarct or a clinically significant Arrhythmia/Conduction Abnormalities within 12 months before the first dose.
• Patients with hypersensitivity (allergic to more than two foods or drugs) or with a history of severe allergy, or patients with Severe allergy to a known experimental drug or to any excipient.
• Patients previously received stem cell therapy or are intolerance to cell therapy;
• Participants in other clinical trials within the last 3 months.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China: collaborator

Study Sites (1)

Beijing 302 Hospital

Beijing, China

Location

Related Publications (1)

• 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

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: July 28, 2023
• First Posted: August 9, 2023
• Study Start: August 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)