Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis

Launched by RESEARCH INSTITUTE FOR GASTROENTEROLOGY AND LIVER DISEASES (RIGLD) · May 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with decompensated liver cirrhosis, a severe stage of liver disease where the liver is not functioning properly. The researchers want to see if exosomes, which are tiny particles derived from mesenchymal stem cells (MSC), can help improve liver function and reduce liver damage. This approach is being explored because MSCs have shown promise in helping with liver issues in previous studies. The trial will focus on patients aged 18 to 75 who have been diagnosed with liver cirrhosis, except for those caused by viral infections.

To participate, individuals should be able to understand the study and provide their consent. They should not have certain medical conditions, such as serious heart disease or active cancer, and they should not be pregnant or breastfeeding. If eligible, participants can expect to receive the MSC-derived exosomes and will be monitored for safety and effectiveness throughout the trial. This study is an important step in exploring new treatments that could potentially help patients with liver cirrhosis who currently have limited options. If you or someone you know is interested in participating, they should consult with their healthcare provider for more details.

Gender

ALL

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.