Clinical trial NCT05080465: Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
Official title: Long Term Follow up Autologous Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Stem Cell
MSC Therapy
Mesenchymal
Lead sponsor: Ukraine Association of Biobank
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: MR Elastography
timeFrame: Change from Baseline (Day 0) until 40 weeks
measure: The level of serum alanine aminotransferase (ALT)
timeFrame: Change from Baseline (Day 0) until 40 weeks
measure: Clinical Examination
timeFrame: Change from Baseline (Day 0) until 40 weeks
measure: The level of glomerular filtration rate (GFR)
timeFrame: Change from Baseline (Day 0) until 40 weeks
Secondary outcomes:
measure: The level of serum albumin (ALB)
timeFrame: Up to 6 months, post-infusion
measure: The level of serum total bilirubin (TB)
timeFrame: Up to 6 months, post-infusion
Other outcomes:
Locations:
city: Kharkov
country: Ukraine
facility: Institute of Bio-Stem Cell Rehabilitation
Study officials:
References: