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

NCT05080465 | Completed Phase 3 DMC

• 1 other identifier: UAB00240818-1
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Stem Cell; MSC Therapy; Mesenchymal

Outcome Measures

Primary Outcomes (4)

• MR Elastography

  The detect liver stiffness of significant or severe fibrosis (≥stage F2)\\(≥stage F3)

  Change from Baseline (Day 0) until 40 weeks

• The level of serum alanine aminotransferase (ALT)

  level of serum alanine aminotransferase less 40 (IU/L)

  Change from Baseline (Day 0) until 40 weeks

• Clinical Examination

  To observe for the following: absence of grade IV anaphylactic reactions (in reference to CTCAE 4.03)

  Change from Baseline (Day 0) until 40 weeks

• The level of glomerular filtration rate (GFR)

  The level of glomerular filtration range from 90 to 120 mL/min/1.73 m2

  Change from Baseline (Day 0) until 40 weeks

Secondary Outcomes (2)

• The level of serum albumin (ALB)

  Up to 6 months, post-infusion

• The level of serum total bilirubin (TB)

  Up to 6 months, post-infusion

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Biological: Autologous BM MSC

Interventions

Autologous BM MSC BIOLOGICAL

A total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ukraine Association of Biobank: lead

Study Sites (1)

Institute of Bio-Stem Cell Rehabilitation

Kharkiv, Ukraine

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: October 15, 2021
• Study Start: December 2, 2018
• Primary Completion: October 7, 2024
• Study Completion: January 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)