Repeated Injection Therapy of Allogeneic Stem Cells in Ischemic No-option Patients - A Multi-Centre Study (SCIENCE REPEAT) - SCIENCE REPEAT

Rigshospitalet0 个研究点目标入组 100 人开始时间: 2019年11月6日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•1.30 to 85 years of age
•2.Written informed consent
•3.Chronic stable ischemic heart disease
•4.Symptomatic heart failure (NYHA II-III)
•5.LVEF =40 % documented by echocardiography, CT or MRI obtained after up-titration of heart failure medication (if previously treated with cardiac resynchronisation at least 3 months after implantation)
•6.Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 49 pmol/L) in those patients with atrial fibrillation
•7.Maximal tolerable heart failure medication
•8.Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics are acceptable
•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 and at least four months after the intervention to rule out early restenosis
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Exclusion criteria
•1.NYHA I or IV heart failure
•2.Implantation of a cardiac resynchronisation therapy device (CRT) within 3 months or Implantable Cardioverter Defibrillator (ICD) 1 month
•3.Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
•4.Other revascularisation treatment within four months of treatment
•5.Moderate to severe aortic stenosis (valve area < 1.3 cm2) 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, severe arthrosis or severe pain from the musculoskeletal system, or morbid obesity
•7.Clinically 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