Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Umbilical cord mesenchymal stem cell-derived extracellular vesicles
  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

Первичные конечные точки

• Frequency and Severity of Adverse Events and Serious Adverse Events [Срок оценки: 9 months from first infusion]

Вторичные конечные точки (4)

• Blood serum biochemical analysis [Срок оценки: Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270]
• Child-Pugh score [Срок оценки: Baseline, day 30, day 60, day 90, day 180, day 270]
• MELD score [Срок оценки: Baseline, day 30, day 60, day 90, day 180, day 270]
• Change in quality of life [Срок оценки: Baseline, day 90, day 180, day 270]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Vinmec Research Institute of Stem Cell and Gene Technology — Hanoi

Идентификаторы

NCT: NCT07472270 · ISC.25.01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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