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IRCT20200809048342N3 IRCT 2023-03-11 Shahid Beheshti University of Medical Sciences Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis Clinical Trial Phase IIa, on Amelioration of Decompensated Liver Cirrhosis with Mesenchymal Stem Cells-derived Exosomes 2023-04-09 anticipated 15 Complete https://irct.ir/trial/68084 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Decompensated Liver Cirrhosis. Intervention group: patients will receive standard medication plus MSC-derived exosomes at a final dose of 40mg in three weeks. Standard medication includes: a) treatment of the underlying cause of cirrhosis such as drug treatment of hepatitis B and C. b) symptomatic treatment of port complications such as ascites, prevention of variceal bleeding, treatment and prevention of hepatic encephalopathy.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Behzad Hatami
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2516 bzd_hatami@yahoo.com Shahid Beheshti University of Medical Sciences scientific Kaveh Baghaei
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
Tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2516 kavehbaghaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 75 years Both 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 K74 Fibrosis and cirrhosis of liver Treatment - Other Intervention group: patients will receive standard medication plus MSC-derived exosomes at a final dose of 40mg in three weeks. Standard medication includes: a) treatment of the underlying cause of cirrhosis such as drug treatment of hepatitis B and C. b) symptomatic treatment of port complications such as ascites, prevention of variceal bleeding, treatment and prevention of hepatic encephalopathy. Liver function by MELD score. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Calculation of MELD score based on patient's laboratory values for serum creatinine, bilirubin, international normalized ratio for prothrombin time, and sodium. Liver function by CHILD score. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Calculation of CHILD score based on patient's laboratory values for serum bilirubin, albumin, international normalized ratio for prothrombin time, ascites, and encephalopathy. Change in liver enzyme AST. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Blood test. Change in liver enzyme ALT. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Blood test. International normalized ratio (INR) for prothrombin time. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Blood test. Bilirubin. Timepoint: Baseline, after 2 and 4 months of the trial. Method of measurement: Blood test. Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2022-11-28 Ethics Committee of Shahid Beheshti University of Medical Science Research Institute for Gastroenterology and Liver Diseases, taleghani hospital, Arabi st., Velenjak ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)