In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled With Ultra-Small Paramagnetic Iron Oxide Particles After Intramyocardial Transplantation in Patients With Chronic Ischemic Heart Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- MSC identification using MRI in-vivo on day 0
研究概览
简要总结
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease.
详细描述
Aims:
To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium.
To evaluate the safety and efficacy of treatment with iron oxide-labeled mesenchymal stromal cells to form new heart muscle cells and blood vessels in the myocardium submitted by NOGA-guided injection therapy in the myocardium in order to improve myocardial blood flow and reduce patients' symptoms.
Patient Population:
Patients with coronary artery disease not treatable with additional bypass surgery or percutaneous coronary intervention who have angina pectoris (Canadian Cardiovascular Society (CCS) class II-III) or angina equivalent shortness of breath (New York Heart Association (NYHA) class II -III).
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
- •Age between 30 and 80 years.
- •Signed informed consent.
- •Chronic stable ischemic heart disease
- •New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV
- •Maximal tolerable angina and/or heart failure medication.
- •Angiography within 12 months of inclusion. Angiography must have at least one larger coronary vessel with a significant stenosis with no option for revascularization (Angiographies evaluated by an independent thoracic surgeon and an interventional cardiologist).
- •Patients who have had revascularization done within 6 months of inclusion must have a new angiography at least 4 months after the intervention to rule out early restenosis.
排除标准
- •Pregnant or fertile women.
- •Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia.
- •Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)<1 L/min, moderate to severe claudication or morbid obesity.
- •Patients with reduced immune response or treated with immunosuppressive medication.
- •Moderate to severe valvular disease or valvular disease with option for valvular surgery.
- •Acute coronary syndrome with elevation of coronary markers, stroke or Transitory Cerebral Ischemia (TCI) within 6 weeks of inclusion.
- •History with malignant disease within 5 years of inclusion or suspected malignity.
- •Other experimental treatment within 4 weeks of baseline evaluation.
- •Other revascularization treatment within 4 months of treatment.
- •Contraindications for Magnetic Resonance Imaging (MRI) such as: Claustrophobia, pacemaker, Implantable Cardioverter Defibrillator (ICD) unit, metal fragments or metal implants in the cranium
研究组 & 干预措施
USPIO labeled MSC injection
USPIO labeled MSC injection
干预措施: USPIO labeled MSC injection (Combination Product)
结局指标
主要结局
MSC identification using MRI in-vivo on day 0
时间窗: 24 hours
Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.
次要结局
- CCS class(26 weeks)
- MSC identification using MRI in-vivo on day 1(1 day)
- MSC identification using MRI in-vivo on day 7(7 days)
- MSC identification using MRI in-vivo after 2 weeks(2 weeks)
- MSC identification using MRI in-vivo after 4 weeks(4 weeks)
- MSC identification using MRI in-vivo after 8 weeks(8 weeks)
- Adverse events(6 months)
- MSC identification using MRI in-vivo after 26 weeks(26 weeks)
- Seattle Angina Questionnaire(26 weeks)
- Weekly nitroglycerin consumption(26 weeks)
- Cardiac pump function changes(26 weeks)
- Weekly number of angina attacks(26 weeks)
- MSC identification using MRI in-vivo after 12 weeks(12 weeks)
研究者
Anders Bruun Mathiasen
Principal Investigator
Rigshospitalet, Denmark