Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis
Decompensated Liver Cirrhosis
About this trial
This is an interventional treatment trial for Decompensated Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria: Able to understand and willing to voluntarily sign an informed consent form (ICF) authorization. Males or females between 18-75 years old with a clinically confirmed diagnosis of Liver cirrhosis with any etiology, except viral cirrhosis. Child score class B or C. Exclusion Criteria: Known cardiovascular disease. a) History of hepatocellular carcinoma (HCC). b) History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous carcinoma at the time of Screening visit. c) Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening visit. Females who are pregnant or breastfeeding. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons). Use of any experimental medications within the last 6 months of Screening Visit. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements. Weight loss of >5% within 6 months prior to Screening, based on subject's reporting. Currently or participated in a weight loss program within the last 6 months. Any history of bariatric surgery. Diabetes mellitus Type I. Daily alcohol intake >20 ml (2 units)/day for women and 30 ml (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire at Screening and plan to consume the same alcohol amount referenced above during the trial. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids >10 mg prednisone-equivalent concurrently or within 1 year prior to Screening. Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator. Uncontrolled arterial hypertension. Any severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the subject inappropriate for entry into this study.
Sites / Locations
- Research Institute of Gastroenterology & Liver DiseasesRecruiting
Arms of the Study
Arm 1
Experimental
Exosome
Standard medication + MSC-derived exosomes at a final dose of 40mg in three weeks