Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis

NCT05948982 | Not Yet Recruiting Phase 1

• 1 other identifier: QS-UCMSC-DLC
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future. Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.

Conditions

Decompensated Liver Cirrhosis

Keywords

Decompensated hepatitis B cirrhosis; Human Umbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (5)

• Adverse Event (AE)

  Adverse events that occurred during the trials

  Through study completion, an average of 1 year

• Serious Adverse Event (SAE)

  Serious adverse events that occurred during the trial

  Through study completion, an average of 1 year

• Recommended dose for phase 2 clinical trial (RP2D)

  Recommended dose for phase 2 clinical trial

  Through study completion, an average of 1 year

• Dose-limiting toxicity (DLT)

  Dose-limiting toxicity

  Through study completion, an average of 1 year

• Maximum Tolerated Dose (MTD)

  Maximum Tolerated Dose

  Through study completion, an average of 1 year

Secondary Outcomes (36)

• Overall survival

  Through study completion, an average of 1 year

• Rate of survival

  Through study completion, an average of 1 year

• Child-Pugh

  Day -14 - Day -1, Day -1, Day 28, Day 56, Week 12, Week 20, Week 32, Week 56

• MELD

  Day -14 - Day -1, Day -1, Day 28, Day 56, Week 12, Week 20, Week 32, Week 56

• Hepatic stiffness

  Day -14 - Day -1, Week 12, Week 20, Week 32, Week 56

Other Outcomes (12)

• IL-1β (Interleukin-1β)

  Day 1, Day 2, Day 3, Day 7, Day 28, Day 29, Day 30, Day 31, Day 35, Day 56, Day 57, Day 58, Day 59, Day 64, Day 85, Week 12, Week 20, Week 32, Week 56

• IL-6 (Interleukin-6)

  Day 1, Day 2, Day 3, Day 7, Day 28, Day 29, Day 30, Day 31, Day 35, Day 56, Day 57, Day 58, Day 59, Day 64, Day 85, Week 12, Week 20, Week 32, Week 56

• IL-8 (Interleukin-8)

  Day 1, Day 2, Day 3, Day 7, Day 28, Day 29, Day 30, Day 31, Day 35, Day 56, Day 57, Day 58, Day 59, Day 64, Day 85, Week 12, Week 20, Week 32, Week 56

Study Arms (1)

Human Umbilical Cord Mesenchymal Stem Cells

EXPERIMENTAL

The trial was divided into three dose groups： Low-dose group: 1000000 cells/kg Medium-dose group: 2000000 cells/kg High-does group: 4000000 cells/kg

Biological: Human Umbilical Cord Mesenchymal Stem Cells

Interventions

Human Umbilical Cord Mesenchymal Stem Cells BIOLOGICAL

The stem cell infusion route is peripheral intravenous infusion, once every 4 weeks for a total of 3 infusions. All subjects received experimental drugs and conventional treatment during the study period.

Human Umbilical Cord 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:

• to 75 years old (including borderline values) at screening, regardless of gender
• Diagnosed with decompensated hepatitis B cirrhosis according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)
• There's no significant reduction in cirrhotic symptoms or no significant improvement in quality of life score after more than 3 months of strict medical conservative treatment
• HBV DNA ≤ 1000 IU/mL at the time of screening
• Fully understand the informed consent form, voluntarily subject to the trial and sign the informed consent form.

You may not qualify if:

• other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease
• Child-Pugh score \>12;
• History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;
• Current serious medical conditions that would affect your safety and treatment efficacy assessment as determined by the investigator, such as: Class II or higher abnormal cardiac function (NYHA criteria), cardiovascular disease such as ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting glucose ≥ 10 mmol/L or glycated hemoglobin (HbA1c) ≥ 8%), serum creatinine \> 2 times the upper limit of normal (ULN), etc;
• Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant upper gastrointestinal hemorrhage event within 4 weeks prior to screening), as determined by the investigator to be unsuitable for participation in this trial;
• Have had hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening
• Spontaneous peritonitis or a more severe active infection within 2 weeks prior to the trial
• Positive infectious disease test (serum anti-HIV antibody, anti-HCV antibody, syphilis antibody either positive) or active tuberculosis;
• Those who have received human albumin within 3 weeks prior to the first infusion of the test drug;
• Those who have the history of venous thrombosis or pulmonary embolism
• Drug addicted or alcohol abusers;
• Women who are pregnant or breastfeeding;
• Persons with a history of severe drug allergy or hypersensitivity;
• History of a serious mental disorder, including uncontrolled major depression or controlled or uncontrolled psychosis, within 24 months prior to screening;
• Those who have participated in other interventional clinical trials within 3 months prior to screening or are participating in other interventional clinical trials, or who have received prior stem cell therapy

Sponsors & Collaborators

• Asia Cell Therapeutics (Shanghai) Co., Ltd.: lead

Study Officials

• Lungen Lu, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenli Liu

CONTACT

+86 13402137712; liuwenli@xibaozhiliao.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 17, 2023
• Study Start: July 30, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share