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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Frequency and Severity of Adverse Events and Serious Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Regimen
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
干预措施: Umbilical cord mesenchymal stem cell-derived extracellular vesicles (Biological)
结局指标
主要结局
Frequency and Severity of Adverse Events and Serious Adverse Events
时间窗: 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.
次要结局
- Blood serum biochemical analysis(Baseline, day 1, day 30, day 31, day 60, day 61, day 90, day 180, day 270)
- Child-Pugh score(Baseline, day 30, day 60, day 90, day 180, day 270)
- MELD score(Baseline, day 30, day 60, day 90, day 180, day 270)
- Change in quality of life(Baseline, day 90, day 180, day 270)