Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure: A Phase II Danish Multicentre Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
研究概览
简要总结
The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.
详细描述
The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design.
A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).
The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 to 80 years of age
- •Signed informed consent
- •Chronic stable ischemic heart disease
- •Symptomatic heart failure - New York Heart Association (NYHA) class II-III
- •Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation
- •Maximal tolerable heart failure medication
- •Medication unchanged two months prior to inclusion
- •No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- •Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
- •Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device
排除标准
- •Heart Failure (NYHA I or IV)
- •Acute coronary syndrome with elevation of creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- •Other revascularisation treatment within four months of treatment
- •If clinically indicated the patient should have a coronary angiography before inclusion
- •Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.
- •Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
- •Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
- •Anticoagulation treatment that cannot be paused during cell injections
- •Patients with reduced immune response
- •History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
- •Pregnant women
- •Other experimental treatment within four weeks of baseline tests
- •Participation in another intervention trial
结局指标
主要结局
change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
时间窗: 6 months
change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
次要结局
- Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up(12 months)
- Efficacy left ventricle(6 months)
- Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up(6 months)
- Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up(12 months)
- Incidence of Treatment-Emergent Adverse Events(12 months)
- Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up(6 months)
- Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up(6 months)
- Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up(12 months)
研究者
JKastrup
Professor Chief Physician
Rigshospitalet, Denmark