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

Launched by BEIJING 302 HOSPITAL · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial, called MSC-DLC-1b, is studying the safety of using special cells derived from human umbilical cords to treat patients with decompensated cirrhosis, a serious liver condition. The main goal is to see if giving these cells through an intravenous infusion (a method of delivering fluids directly into a vein) is safe for patients who have this condition. The trial is not yet recruiting participants, but when it starts, it will include men and women aged 18 to 75 who have been diagnosed with decompensated liver cirrhosis and have certain health scores (specifically, a Child-Turcotte-Pugh score between 7 and 12).

To be eligible for this trial, participants must be willing to provide written consent and meet specific health criteria, such as having serious complications related to their liver condition. However, certain individuals will not be eligible, including those with active hepatitis infections, recent organ transplants, severe heart or lung diseases, or those who are pregnant or breastfeeding. Participants in the trial can expect close monitoring for their safety throughout the study. This trial represents a potential new approach to treating a challenging health issue, and it aims to provide valuable insights into the use of stem cells for liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing to provide written informed consent;
• • 2. Aged 18 to 75 years (including 18 and 75 years), male or female;
• • 3. 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);
• • 4. Child-Turcotte-Pugh (CTP) score 7 to 12 points.
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
• • 4. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
• • 5. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
• • 6. Patients with biliary obstruction, or portal patients with vein spongiosis.
• • 7. 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.
• • 8. Patients with history of organ transplantation.
• • 9. Patients with severe heart, lung, kidney and blood system diseases.
• • 10. Patients with drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
• • 11. Patients with history of immunodeficiency disease, including a positive test result for human immunodeficiency virus (HIV) antibodies, or other acquired or congenital immunodeficiency diseases;
• • 12. 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.
• • 13. 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.
• • 14. 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.
• • 15. Patients previously received stem cell therapy or are intolerance to cell therapy;
• • 16. Participants in other clinical trials within the last 3 months.
• • 17. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.