Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis
- Conditions
- Decompensated Liver Cirrhosis.Fibrosis and cirrhosis of liver
- Registration Number
- IRCT20200809048342N3
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver 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.
- Secondary Outcome Measures
Name Time Method 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.