Liver CirrhosisPhase 1NCT07472270
Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment
A Phase 1 study testing Umbilical cord mesenchymal stem cell-derived extracellular vesicles in people with Liver Cirrhosis, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial summary
This study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Umbilical cord mesenchymal stem cell-derived extracellular vesicles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Mar 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis due to alcohol-related liver disease or chronic hepatitis B or C
- Child-Pugh score 7-12
- Alcohol-related cirrhosis: abstinent from alcohol ≥ 3 months
- HBV/HCV-related cirrhosis: viral disease controlled according to standard clinical criteria
- Written informed consent provided
Who cannot join
- Significant renal dysfunction or coagulation abnormalities
- Liver cirrhosis of unknown etiology
- Current or suspected hepatocellular carcinoma or history of malignancy
- Portal vein thrombosis
- Pregnancy, breastfeeding, or inadequate contraception
- Severe renal, respiratory, cardiovascular, infectious, autoimmune, metabolic, or neurological disorders that may interfere with study participation
Show all 9Show fewer
- Refractory ascites at screening
- Use of known hepatotoxic medications within a clinically relevant period
- Coinfection with HIV, tuberculosis, or other causes of chronic liver disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Van T. Hoang contact
Vietnam1 site
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000
Thanh Liem Nguyen, +84 4 3974 3556, v.liemnt@vinmec.com
About this study
Official title: Phase 1 Clinical Trial: Evaluation of the Safety and Preliminary Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Extracellular Vesicle Therapy in the Treatment of Liver Cirrhosis
This study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. The trial uses a rolling six dose-escalation design, enrolling up to 12 adult patients (18-75 years) with Child-Pugh scores of 7-12.
The results of this study are expected to provide initial clinical evidence supporting the safety and potential therapeutic role of UC-MSC-EVs as a novel cell-free treatment approach for liver cirrhosis.
- Conditions
- Liver Cirrhosis
- Being tested
- Umbilical cord mesenchymal stem cell-derived extracellular vesicles
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord mesenchymal stem cell-derived extracellular vesiclesBiological
Also called UC-MSC-EV, VinEV-3
Dimedrol 20 mg will be administered intravenously 15-30 minutes prior to EV infusion. VinEV-3 will be administered at a starting dose of 2 × 10¹⁰ EV particles/kg, with dose escalation to 4 × 10¹⁰ EV particles/kg in the absence of dose-limiting toxicity or dose reduction to 1 × 10¹⁰ EV particles/kg if dose-limiting toxicity occurs. Three infusions will be given at 30 ± 5 day intervals, 3 times, with safety follow-up through 9 months after the first infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen | Experimental | Participants in this experimental arm will receive intravenous VinEV-3. Premedication with Dimedrol will be administered prior to infusion. VinEV-3 will be diluted in 0.9% sodium chloride to a total volume of 100 mL and infused over approximately 60 minutes. A dose-escalation design will be applied with safety-based dose adjustment. Participants will receive three infusions administered at 30 ± 5 day intervals, while continuing standard-of-care treatment. Patients will be followed for safety and clinical outcomes at 3, 6, and 9 months after the first infusion Receives: Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Adverse Events and Serious Adverse Events
Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 and dose-limiting toxicities (DLTs) when administered VinEV-3 at escalating dose levels.
Measured: 9 months from first infusion
Secondary outcomes (4)
Blood serum biochemical analysis
Assessment of changes in serum albumin (ALB), AST, ALT, GGT, ALP levels
Measured: Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270
Child-Pugh score
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. It consists of five clinical measures: total bilirubin, serum albumin, prothrombin time (INR), ascites, and hepatic encephalopathy. The total score ranges from 5 to 15, where higher scores indicate worse hepatic impairment (Class A: 5-6 points, Class B: 7-9 points, and Class C: 10-15 points).
Measured: Baseline, day 30, day 60, day 90, day 180, day 270
MELD score
The Model for End-Stage Liver Disease (MELD) is a scoring system used to estimate the severity of chronic liver disease. The score is calculated using a formula that includes serum bilirubin, serum creatinine, and the international normalized ratio (INR). MELD scores range from 6 to 40, where a higher score indicates a more severe disease state and a higher risk of mortality
Measured: Baseline, day 30, day 60, day 90, day 180, day 270
Change in quality of life
Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey. The survey consists of 36 questions covering 8 health domains. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better quality of life and better health status.
Measured: Baseline, day 90, day 180, day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Intervention therapy: VinEV-3 (MSC-derived extracellular vesicles) * Premedication: diphenhydramine (Dimedrol) 20 mg i.v., 15-30 minutes before EV infusion * Route: intravenous * Dose levels: * Starting dose: 2 × 10¹⁰ EV particles/kg * Higher dose: 4 × 10¹⁰ EV particles/kg * Dose reduction to 1 × 10¹⁰ EV particles/kg in case of dose-limiting toxicity * Infusion volume: 100 mL (VinEV-3 diluted in 0.9% sodium chloride) * Infusion duration: \~60 minutes (\~1.67 mL/min) * Administration: 3 infusions, 30 ± 5 days apart * Follow-up: 3, 6, and 9 months after first infusion * Concomitant therapy: standard of care, including antiviral therapy for hepatitis B when applicable
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thanh Liem Nguyen, Principal investigator, Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam 100000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472270
- Sponsor's protocol ID
- ISC.25.01
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial: Evaluation of the Safety and Preliminary Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Extracellular Vesicle Therapy in the Treatment of Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07472270
- Acronym / sponsor ID
- ISC.25.01
- Conditions
- Liver Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (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 study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. The trial uses a rolling six dose-escalation design, enrolling up to 12 adult patients (18-75 years) with Child-Pugh scores of 7-12.
The results of this study are expected to provide initial clinical evidence supporting the safety and potential therapeutic role of UC-MSC-EVs as a novel cell-free treatment approach for liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Intervention therapy: VinEV-3 (MSC-derived extracellular vesicles) * Premedication: diphenhydramine (Dimedrol) 20 mg i.v., 15-30 minutes before EV infusion * Route: intravenous * Dose levels: * Starting dose: 2 × 10¹⁰ EV particles/kg * Higher dose: 4 × 10¹⁰ EV particles/kg * Dose reduction to 1 × 10¹⁰ EV particles/kg in case of dose-limiting toxicity * Infusion volume: 100 mL (VinEV-3 diluted in 0.9% sodium chloride) * Infusion duration: ~60 minutes (~1.67 mL/min) * Administration: 3 infusions, 30 ± 5 days apart * Follow-up: 3, 6, and 9 months after first infusion * Concomitant therapy: standard of care, including antiviral therapy for hepatitis B when applicable
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen | Experimental | Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesiclesParticipants in this experimental arm will receive intravenous VinEV-3. Premedication with Dimedrol will be administered prior to infusion. VinEV-3 will be diluted in 0.9% sodium chloride to a total volume of 100 mL and infused over approximately 60 minutes. A dose-escalation design will be applied with safety-based dose adjustment. Participants will receive three infusions administered at 30 ± 5 day intervals, while continuing standard-of-care treatment. Patients will be followed for safety and clinical outcomes at 3, 6, and 9 months after the first infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Liver cirrhosis due to alcohol-related liver disease or chronic hepatitis B or C
- Child-Pugh score 7-12
- Alcohol-related cirrhosis: abstinent from alcohol ≥ 3 months
- HBV/HCV-related cirrhosis: viral disease controlled according to standard clinical criteria
- Written informed consent provided
Key exclusion criteria (9 listed)
- Significant renal dysfunction or coagulation abnormalities
- Liver cirrhosis of unknown etiology
- Current or suspected hepatocellular carcinoma or history of malignancy
- Portal vein thrombosis
- Pregnancy, breastfeeding, or inadequate contraception
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 |
|---|---|---|
| Umbilical cord mesenchymal stem cell-derived extracellular vesiclesAlso: UC-MSC-EV, VinEV-3Dimedrol 20 mg will be administered intravenously 15-30 minutes prior to EV infusion. VinEV-3 will be administered at a starting dose of 2 × 10¹⁰ EV particles/kg, with dose escalation to 4 × 10¹⁰ EV particles/kg in the absence of dose-limiting toxicity or dose reduction to 1 × 10¹⁰ EV particles/kg if dose-limiting toxicity occurs. Three infusions will be given at 30 ± 5 day intervals, 3 times, with safety follow-up through 9 months after the first infusion | Biological | Treatment Regimen |
Primary outcome
Frequency and Severity of Adverse Events and Serious Adverse Events
Time frame: 9 months from first infusion
Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 and dose-limiting toxicities (DLTs) when administered VinEV-3 at escalating dose levels.
4 secondary outcomes
Blood serum biochemical analysis
Time frame: Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270
Child-Pugh score
Time frame: Baseline, day 30, day 60, day 90, day 180, day 270
MELD score
Time frame: Baseline, day 30, day 60, day 90, day 180, day 270
Change in quality of life
Time frame: Baseline, day 90, day 180, day 270
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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.
Van T. Hoang contact
Thanh Liem Nguyen principal investigator
Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam 100000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Umbilical cord mesenchymal stem cell-derived extracellular vesicles in people with Liver Cirrhosis, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Mar 2026. 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 Vietnam. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanh Liem Nguyen ((+84) 98 656 50 15, v.liemnt@vinmec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Severity of Adverse Events and Serious Adverse Events (time frame: 9 months from first infusion). 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 16 Mar 2026.