NCT03508609已完成2 期
An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change From Baseline in Coronary Flow Reserve
研究概览
简要总结
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age ≥18
- •History of and currently experiencing angina at least 3 times per week
- •No obstructive coronary artery disease
- •On stable medical therapy for 30 days prior to enrollment
- •Must agree to use a reliable and acceptable method of contraception for the duration of participation
- •Written informed consent
排除标准
- •Myocardial infarction within 90 days
- •Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
- •Diagnosis of other specific cardiac disease
- •Must meet LVEF and GFR requirements
- •Current use of coumadin or DOACs
- •Hypersensitivity to G-CSF, apheresis or study product components
- •Positive for HIV, hepatitis B or hepatitis C
- •Active inflammatory or autoimmune disease, or chronic immunosuppressive state
- •Drug abuse
- •Pregnant or lactating
- •Malignant neoplasm within 5 years
- •History of Sickle Cell Disease
- •Participation in another clinical study within 90 days
研究组 & 干预措施
Autologous CD34 cells
Experimental
Open label active treatment arm. Subjects receive autologous CD34 cells.
干预措施: CLBS16 (Biological)
结局指标
主要结局
Change From Baseline in Coronary Flow Reserve
时间窗: Day 180
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
次要结局
- Change From Baseline in Peripheral Arterial Tonometry(Day 180)
- Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine(Day 180)
- Change in Angina Frequency From Baseline(6 months)
- Change From Baseline in Seattle Angina Questionnaire(6 months)
- Change From Baseline in SF-36 Scores(6 months)
- Canadian Cardiovascular Society Angina Class(6 months)
研究者
研究点 (2)
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