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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord mesenchymal stem cell-derived extracellular vesicles | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months from first infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Blood serum biochemical analysis | Assessment of changes in serum albumin (ALB), AST, ALT, GGT, ALP levels | Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270 |
| Child-Pugh score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Liem Nguyen | Contact | (+84) 98 656 50 15 | v.liemnt@vinmec.com | |
| Van T. Hoang | Contact | +84 93 644 94 81 |
| Name | Affiliation | Role |
|---|---|---|
| Thanh Liem Nguyen | Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam 100000 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | 100000 | Vietnam |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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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:
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
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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).
| 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 | 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. | Baseline, day 90, day 180, day 270 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |