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

NCT05871463 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-23

No results posted yet for this study

Summary

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, mesenchymal stem cell (MSC) transfusion has been shown to lead to the regression of liver fibrosis in mice and humans. However, little is known about MSC-exosome therapy. We will evaluate the therapeutic potential of mesenchymal stem Cell-Exosomes as an alternative to cell therapy in Cirrhotic patients. This study examined the safety and efficacy of umbilical cord-derived MSC-exosomes in patients with decompensated LC.

Conditions

  • Decompensated Liver Cirrhosis

Interventions

BIOLOGICAL

MSC-derived exosomes

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.

Sponsors & Collaborators

  • Research Institute for Gastroenterology and Liver Diseases (RIGLD)

    lead NETWORK

Principal Investigators

  • Behzad Hatami, MD · Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti Medical University, Tehran, Iran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2023-08-11
Completion
2023-12-11

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871463 on ClinicalTrials.gov