An Open-Label, Single-Arm, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Tolerability of SNE-101 in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke
详细描述
The study aims to assess the safety, tolerability, and preliminary efficacy of allogeneic Wharton's jelly-mesenchymal stem cell-derived extracellular vesicles (EVs) in patients with acute ischemic stroke.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with 19 years or older
- •Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures.
- •Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation.
- •Imaging findings must meet both of the following:
- •Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)
- •Infarct size ≥ 20 mm in the longest diameter on DWI
- •Neurological status meeting all three of the following NIHSS criteria:
- •Moderate to severe neurological deficit (NIHSS score between 5-21)
- •New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b)
- •No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c)
- •Voluntary written informed consent
排除标准
- •Subjects are ineligible if they meet any of the following:
- •Pre-stroke disability (pre-stroke mRS ≥ 2)
- •Likely to recover spontaneously, based on all three of:
- •No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy
- •Lacunar stroke due to small vessel occlusion
- •SAFE (Shoulder Abduction and Finger Extension) score ≥ 5
- •Presence or risk of malignant middle cerebral artery infarction with brain edema
- •Significant medical history within the past 5 years:
- •Severe heart failure
- •Severe infectious disease
- •Severe hepatic failure or renal failure
- •Newly diagnosed or actively treated cancer
- •Any systemic disease deemed by investigator to significantly reduce life expectancy
- •Any condition likely to hinder follow-up during the study
- •Diagnosed severe psychiatric illness:
- •Moderate or greater depression pre-stroke with functional impairment and suicide risk
- •Pre-stroke dementia interfering with daily living (CDR ≥ 2)
- •Contraindication to MRI (e.g., pacemaker)
- •Pregnant or breastfeeding, or unwilling to use effective contraception method for 90 days after last dose.
- •Participation in another clinical trial within the past 3 months
- •Any other reason determined by the investigator that would prevent participation
研究组 & 干预措施
SNE-101
Patients will be given SNE-101, an extracellular vesicle derived from Wharton's jelly mesenchymal stem cells.
• Drug: SNE-101
- Three multiple doses of SNE-101 will be administered to three study cohorts , each consisting of 3 to 6 subjects.
- SNE-101 will be administered intravenously once a day for 5 days.
干预措施: SNE-101 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
时间窗: MTD: within 19 days after first dose
o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
时间窗: Adverse events: 180 days
o Adverse events are monitored continuously throughout the study.
次要结局
- To assess the efficacy of SNE-101 in patients with acute ischemic stroke.(13 weeks)