Exploratory Study of Intranasal Administration of Small Extracellular Vesicles Derived From Human Umbilical Cord Mesenchymal Stem Cells hUC-MSC-sEV-001 in the Treatment of Ischemic Stroke Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001
研究概览
简要总结
Evaluation of the Safety and Preliminary Efficacy of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) in Patients for Ischemic Stroke
详细描述
Based on adhering to the GCP principles of national clinical trial research and the standardized processes of CROs, this study aims to evaluate the safety and preliminary efficacy of hUC-MSC-sEV-001 in treating ischemic stroke by recruiting a small sample population. Additionally, the study will seek to determine an appropriate dosage, laying the foundation for subsequent research.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intranasal Administration of hUC-MSC-sEV-001 Therapy
Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
干预措施: Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy (Biological)
结局指标
主要结局
Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001
时间窗: Day 14 (+-2) post-enrollment
Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001 Includes: 1. Grade 3-4 severe adverse events occurring on day 14 (+-2), graded according to Common Terminology Criteria for Adverse Events （CTCAE） V5.0; 2. NIHSS score increase of ≥4 from baseline on day 14 (+-2); NIHSS score assessed by a professional rehabilitation physician; 3. Symptomatic intracranial hemorrhage occurring on day 14 (+-2); detected via CT scan and patient symptom presentation.
次要结局
- Serious adverse events related to the investigational drug within 90 (+-7) days(At baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment)
- Distribution of Modified Rankin Scale (mRS) Scores within 90 (+-7) days(baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment)
- Barthel Index within 90 (±7) days(baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment)
- Five-level, five-dimensional EuroQol (EQ-5D-5L)(baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment)
- Proportion of Modified Rankin Scale (mRS) Scores of 0-2 within 90 (+-7) days(baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment)
- Changes in infarct volume at 14 (+-2) days compared to baseline(baseline, Day 14 (+-2) post-enrollment)
- Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score(baseline, Day 7 (+-1) and Day 14 (+-2)post-enrollment)
- All-cause mortality at 90 (+-7) days(Day 90 (+-7)post-enrollment)