A Phase I/II, Randomised, Double-blind, Placebo Controlled, Single-centre Study of Bone Marrow Mononuclear Cells by Percutaneous Retrograde Coronary Venous Delivery to Patients With Ischaemic Heart Failure and no Standard Revascularisation Options.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety: up to one year
研究概览
简要总结
Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart muscle means that it functions inefficiently, and leads to symptoms of shortness of breath, chest pain and excess fluid in the body. Recently it has been shown that cells from the inside of bone are able to produce many different cell types. We are investigating a new treatment in which a patient's bone marrow cells are taken, and injected into the heart in an attempt to produce new blood vessels and heart muscle cells. This may lead to a new treatment for ischaemic heart disease.
详细描述
Study Objectives:
- Evaluate the safety of a single administration of bone marrow mononuclear cells by retrograde coronary venous delivery.
- Evaluate the bioactivity of bone marrow mononuclear cells in mediating increased perfusion in viable underperfused areas of myocardium.
- Evaluate the ability of bone marrow mononuclear cells to improve myocardial function specifically regional wall motion and cardiac synchronisation.
- Evaluate the use of potential bioactivity assays and clinical outcomes for assessing bone marrow mononuclear cell- induced myocardial changes.
Study Design:
A phase I/II, randomised, double-blind, placebo controlled, single-centre study of bone marrow mononuclear cells by percutaneous retrograde coronary venous delivery to patients with ischaemic heart failure and no standard revascularisation options.
Study Population:
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic ischaemic multi-vessel coronary artery disease (CAD) not suitable for standard revascularization procedures such as CABG, PCI, LVAD, or heart transplant.
- •Area of reversible inducible ischaemia (>10% of LV on SPECT) performed not more than six months prior to study treatment.
- •LVEF < 45% on optimal medical therapy.
- •NYHA class II- IV patient stable on optimal medical therapy for at least 30 days.
- •Written informed consent and agree to attend hospital appointments for 1 year.
- •Male and females 18 to 80 years of age.
排除标准
- •Left ventricular aneurysm or thrombus.
- •Thoracic aortic aneurysm.
- •Congenital Heart disease
- •Acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
- •Contraindication to MRI or any other study procedure.
- •Presence or history of cancer (except low grade and fully resolved non-melanoma skin malignancy).
- •Any co-morbidity likely to reduce short- term survival or which may interfere with functional testing.
- •Recent myocardial infarction < 6mths.
- •Cerebral vascular accident < 6mths.
- •Active hepatitis, receiving immunosuppressive therapy, undergoing haemodialysis.
- •Clinically significant abnormal haematology.
- •Recent history of alcoholism, drug abuse, or severe emotional, behavioural, or psychiatric problems.
- •Fertile women who are pregnant, nursing, or using no form of contraception.
- •Receiving experimental medications or participating in another study within 12 weeks of enrolment into this study.
结局指标
主要结局
Safety: up to one year
Efficacy
Perfusion (MIBI SPECT)
Function (CMR)
Co-primary endpoints at 180 Days
次要结局
- Function (ECHO, SPECT)
- Efficacy: at 180 days
- Exercise (VO2 Max)
- QOL
- Perfusion (CMR)