Liver CirrhosisPhase 3NCT05080465
Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
A Phase 3 study testing Autologous BM MSC in people with Liver Cirrhosis, run by Ukraine Association of Biobank at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Autologous BM MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUkraine
- Study dates
- 2 Dec 2018to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow up Autologous Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
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
Read the 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).
- Conditions
- Liver Cirrhosis
- Being tested
- Autologous BM MSC
- Keywords
- Liver Cirrhosis, Fibrosis, Pathologic Processes, Liver Diseases, Digestive System Diseases, Stem Cell, MSC Therapy, Mesenchymal
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Pathologic Processes, Liver Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BM MSCBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous BM MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR Elastography
The detect liver stiffness of significant or severe fibrosis (≥stage F2)\(≥stage F3)
Measured: Change from Baseline (Day 0) until 40 weeks
The level of serum alanine aminotransferase (ALT)
level of serum alanine aminotransferase less 40 (IU/L)
Measured: 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)
Measured: 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
Measured: Change from Baseline (Day 0) until 40 weeks
Secondary outcomes (2)
The level of serum albumin (ALB)
The level of serum albumin to 5.4 g/dL
Measured: Up to 6 months, post-infusion
The level of serum total bilirubin (TB)
The level of serum total bilirubin 1.8 mg/dL
Measured: Up to 6 months, post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start2 Dec 2018
- Primary completion7 Oct 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukraine Association of Biobank
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080465
- Sponsor's protocol ID
- UAB00240818-1
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up Autologous Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05080465
- Acronym / sponsor ID
- UAB00240818-1
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Fibrosis, Pathologic Processes, Liver Diseases, Digestive System Diseases, Stem Cell, MSC Therapy, Mesenchymal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Ukraine Association of BiobankUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Autologous BM MSCA 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous BM MSCA 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. | Biological | Treatment Arm |
Primary outcome
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)
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)
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)
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
2 secondary outcomes
The level of serum albumin (ALB)
Time frame: Up to 6 months, post-infusion
The level of serum total bilirubin (TB)
Time frame: Up to 6 months, post-infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous BM MSC in people with Liver Cirrhosis, run by Ukraine Association of Biobank at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR Elastography (time frame: Change from Baseline (Day 0) until 40 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.