Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- left ventricle end-systolic volume (LVESV)
研究概览
简要总结
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.
详细描述
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure.
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 EF (≤45%) and heart failure in a double-blind placebo-controlled design.
A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).
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
- 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
- •EF ≤ 45% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan
- •Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
- •Maximal tolerable heart failure medication
- •Heart failure medication unchanged two months prior to inclusion. Changes in diuretics accepted.
- •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 coronary 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 (CRTD) and until 1 month after an ICD unit
排除标准
- •Heart Failure (NYHA class I or IV)
- •Acute coronary syndrome with acute reversible elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient.
- •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 cm2) or valvular disease with option for surgery or interventional therapy.
- •Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients.
- •If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
- •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)
- •Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 ml/min)
- •Left ventricular thrombus
- •Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment
- •Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies
- •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
- •Life expectancy less than one year
- •Known hypersensitivity to Dimethyl sulfoxide (DMSO), penicillin and streptomycin
结局指标
主要结局
left ventricle end-systolic volume (LVESV)
时间窗: 6 months
The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC_ASC and placebo treated
次要结局
- Safety - Serious adverse events(6 months)
研究者
JKastrup
MD Professor
Rigshospitalet, Denmark