A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 14
- 主要终点
- Change from baseline in total exercise time
研究概览
简要总结
This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of CLBS16 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
- •Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
- •No obstructive coronary artery disease
- •On stable medical therapy for at least 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 GCSF, 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 prior to informed consent or concurrently with this study
- •Previous treatment with a CD34+ cell based therapy
研究组 & 干预措施
GCSF-mobilized autologous CD34+ cells
干预措施: CLBS16 (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Change from baseline in total exercise time
时间窗: Baseline to 6 months
Change from baseline in CCS angina class
时间窗: Baseline to 3 and 6 months
Change from baseline in health-related quality of life (HRQoL)
时间窗: Baseline to 3 and 6 months
Change from baseline in angina frequency
时间窗: Baseline to 3 and 6 months
Change From Baseline in Number of Angina Attacks Per Week
时间窗: Baseline to Month 3
Change From Baseline in CCS Angina Class
时间窗: Baseline to 3 months
This measure assesses the change in the Canadian Cardiovascular Society angina class scale. CCS angina class was assessed at baseline and again at 3 months and reported as the mean difference. CCS classes are as follows (negative change indicates an improvement): Class 0: No angina with ordinary activity Class I: Angina only with strenuous, prolonged, or rapid exertion Class II: Angina with slight limitations of ordinary activity (e.g., walking uphill, climbing stairs) Class III: Angina with marked limitations of ordinary activity (e.g., walking one to two blocks, climbing one flight of stairs) Class IV: Angina at rest or with minimal exertion
Change From Baseline in Total Exercise Time
时间窗: Baseline to 6 months
Change From Baseline in Health-related Quality of Life (HRQoL)
时间窗: Baseline to 3 months
Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better
次要结局
未报告次要终点