Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis

Last updated: April 8, 2024
Sponsor: Ukraine Association of Biobank
Overall Status: Active - Not Recruiting

Phase

3

Condition

Scar Tissue

Hyponatremia

Hepatic Fibrosis

Treatment

Autologous BM MSC

Clinical Study ID

NCT05080465
UAB00240818-1
  • Ages 18-69
  • All Genders

Study Summary

This is a study to assess safety and preliminary clinical activity of treatments of liver cirrhosis in patients with caused by Hepatitis C and Hepatitis B or Nonalcoholic Steatohepatitis of Mesenchymal stem cell.

Patients who will be enrolled in the study will be under supervision and monitoring to ensure clinical significance

Eligibility Criteria

Inclusion

Inclusion Criteria: Provision of written informed consent for this study by subject or as applicable legalguardians Able to comply with study requirements Еру rates with RVR defined as serum HCVRNA undetectable after 12 month after antiviral therapy. Subject must have documented compensated cirrhosis and no current or past clinical evidenceof decompensated liver disease Subject must have documented history Screening laboratoryresult indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection

Exclusion

Exclusion Criteria: Positive test result at screening for Hepatitis B surface antigen or anti-humanimmunodeficiency virus (anti-HIV) antibody HCV genotype performed during screeningindicating co-infection with more than 1 HCV genotype.

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: Autologous BM MSC
Phase: 3
Study Start date:
December 02, 2018
Estimated Completion Date:
December 31, 2025

Study Description

Liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. It can result from a variety of causes, ranging from hepatitis B and C infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. Irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course.

Liver cirrhosis is irreversible and most patients will progressively worsen over time. Once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%.

The definitive treatment of decompensated cirrhosis is liver transplantation. While a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. The vast majority do not have an effective option at all, thus the need to develop alternative therapies. Various types of Stem Cells had been investigated as a regenerative therapy for liver cirrhosis. These stem cells include bone marrow mesenchymal stem cells (MSC). Some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. There was improved liver function in these patients with cirrhotic livers.

The sponsor is proposing a study to look into the role of MSC therapy for patients with liver cirrhosis in Ukraine. This will be a Phase I study with the main emphasis on the safety and efficiency profile first. The trial will be conducted in compliance with the protocol, GCP and local regulatory requirement(s).

Connect with a study center

  • Institute of Bio-Stem Cell Rehabilitation

    Kharkov,
    Ukraine

    Site Not Available

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