NCT04614467
终止
2 期
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
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Coronary Microvascular Dysfunction
- 发起方
- Lisata Therapeutics, Inc.
- 入组人数
- 34
- 试验地点
- 7
- 主要终点
- Change from baseline in total exercise time
- 状态
- 终止
- 最后更新
- 2年前
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.
研究者
入排标准
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
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
研究点 (7)
Loading locations...
相似试验
Unknown
1 期
An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.HIV InfectionsAIDSNCT03517631Shanghai Public Health Clinical Center6
已完成
2 期
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery DiseaseCoronary Microvascular DysfunctionNCT03508609Lisata Therapeutics, Inc.20
已完成
1 期
A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fractureon-Union FractureJPRN-UMIN000002993Ryosuke Kuroda, M.D., Ph.D.17
进行中（未招募）
1 期
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for RetinopathyNon-exudative Age-related Macular DegenerationDiabetic RetinopathyRetina Vein OcclusionRetinitis PigmentosaHereditary Macular DegenerationNCT01736059University of California, Davis15
招募中
不适用
CD34+ Selected Stem Cell for Poor Graft Function or Graft FailureGraft FailurePoor Graft FunctionNCT06569082NYU Langone Health21