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

Phase 3

Active, not recruiting

• Conditions: Liver Cirrhosis
• Interventions: Biological: Autologous BM MSC

• Registration Number: NCT05080465
• Lead Sponsor: Ukraine Association of Biobank

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2018-12-02
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-10-07
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Provision of written informed consent for this study by subject or as applicable legal guardians Able to comply with study requirements Еру rates with RVR defined as serum HCV RNA undetectable after 12 month after antiviral therapy.

Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease Subject must have documented history Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection

Exclusion Criteria

Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Autologous BM MSC	A single dose of 0.5 to 1 x 10\^6/kg autologous BM MSCs (Total volume: 30 - 50 ml) will be infused via peripheral venous access.

Primary Outcome Measures

Name	Time	Method
MR Elastography	Change from Baseline (Day 0) until 40 weeks	The detect liver stiffness of significant or severe fibrosis (≥stage F2)\\(≥stage F3)
The level of glomerular filtration rate (GFR)	Change from Baseline (Day 0) until 40 weeks	The level of glomerular filtration range from 90 to 120 mL/min/1.73 m2
The level of serum alanine aminotransferase (ALT)	Change from Baseline (Day 0) until 40 weeks	level of serum alanine aminotransferase less 40 (IU/L)
Clinical Examination	Change from Baseline (Day 0) until 40 weeks	To observe for the following: absence of grade IV anaphylactic reactions (in reference to CTCAE 4.03)

Secondary Outcome Measures

Name	Time	Method
The level of serum albumin (ALB)	Up to 6 months, post-infusion	The level of serum albumin to 5.4 g/dL
The level of serum total bilirubin (TB)	Up to 6 months, post-infusion	The level of serum total bilirubin 1.8 mg/dL

Trial Locations

Locations (1)

Institute of Bio-Stem Cell Rehabilitation; 🇺🇦 Kharkov, Ukraine