Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
研究概览
简要总结
The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.
详细描述
Patients with heart failure will be treated with culture expanded adipose tissue derived mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be injected directly into the myocardium using the NOGA XP method.
The patients will be followed for 6 months for safety and efficacy registration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 IHD
- •HF (NYHA II-III)
- •Maximal tolerable angina and heart failure medication
- •Medication unchanged two months prior to inclusion
- •Angiography within six months of 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 six 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 CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- •Other revascularisation treatment within four months of treatment
- •Moderate to severe valvular disease or valvular disease with option for valvular surgery
- •Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
- •Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia
- •Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections
- •Patients with reduced immune response or treated with immunosuppressive medication
- •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
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
时间窗: 6 months
Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period
次要结局
- Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)(6 months)
研究者
JKastrup
Professor Chief Physician
Rigshospitalet, Denmark