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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05080465
Recruitment Status : Active, not recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Autologous BM MSC Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long Term Follow up Autologous Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
Actual Study Start Date : December 2, 2018
Actual Primary Completion Date : October 7, 2021
Estimated Study Completion Date : February 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: Treatment Arm
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
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.




Primary Outcome Measures :
  1. MR Elastography [ Time Frame: Change from Baseline (Day 0) until 40 weeks ]
    The detect liver stiffness of significant or severe fibrosis (≥stage F2)\(≥stage F3)

  2. The level of serum alanine aminotransferase (ALT) [ Time Frame: Change from Baseline (Day 0) until 40 weeks ]
    level of serum alanine aminotransferase less 40 (IU/L)

  3. Clinical Examination [ Time Frame: 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)


  4. The level of glomerular filtration rate (GFR) [ Time Frame: Change from Baseline (Day 0) until 40 weeks ]
    The level of glomerular filtration range from 90 to 120 mL/min/1.73 m2


Secondary Outcome Measures :
  1. The level of serum albumin (ALB) [ Time Frame: Up to 6 months, post-infusion ]
    The level of serum albumin to 5.4 g/dL

  2. The level of serum total bilirubin (TB) [ Time Frame: Up to 6 months, post-infusion ]
    The level of serum total bilirubin 1.8 mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080465


Locations
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Ukraine
Institute of Bio-Stem Cell Rehabilitation
Kharkov, Ukraine
Sponsors and Collaborators
Ukraine Association of Biobank
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Responsible Party: Ukraine Association of Biobank
ClinicalTrials.gov Identifier: NCT05080465    
Other Study ID Numbers: UAB00240818-1
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ukraine Association of Biobank:
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Stem Cell
MSC Therapy
Mesenchymal
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases