Allogeneic adipose tissue-derived stromal/stem cell therapy in patients with ischemic heart disease and heart failure - CSCC_ASC2

Department of Cardiology, Rigshospitalet0 个研究点开始时间: 2015年5月12日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•1.30 to 80 years of age
•2.Signed informed consent
•3.Chronic stable ischemic heart disease
•4.Heart failure (NYHA II-III)
•5.LVEF =45%
•6.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
•7.Maximal tolerable heart failure medication
•8.Medication unchanged two months prior to inclusion
•9.No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
•10.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
•11.Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 61

•Exclusion criteria
•1.Heart Failure (NYHA I or IV)
•2.Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
•3.Other revascularisation treatment within four months of treatment
•4.If clinically indicated the patient should have a coronary angiography before inclusion
•5.Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.
•6.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
•7.Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
•8.Anticoagulation treatment that cannot be paused during cell injections
•9.Patients with reduced immune response
•10.History with malignant disease within five years of inclusion or suspected malignity – except treated skin cancer other than melanoma
•11.Pregnant women
•12.Other experimental treatment within four weeks of baseline tests
•13.Participation in another intervention trial

发起方

Department of Cardiology, Rigshospitalet