Mesenchymal Stem Cell Administration in the Treatment of Coronary Graft Disease in Heart Transplant Patients
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- myocardial perfusion measured in MRI.
研究概览
简要总结
MES-HT is a pilot multicenter prospective study conducted in transplant patients who developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of bone marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping system.
The main objective is to determine the effect of the administration of autologous mesenchymal cells of the bone marrow by intramyocardial injection on myocardial perfusion in cardiac transplant patients with severe coronary vasculopathy.
详细描述
MES-HT is a phase 1-2 multicenter pilot prospective study conducted on 14 heart transplant patients who developed severe coronary vasculopathy, in the aim to assess the effect on myocardial perfusion of the intramyocardial administration by percutaneous way of autologous mesenchymal stem cells derived from the bone marrow.
The main objective is to show improvement in myocardial perfusion in a non-randomized and uncontrolled pilot study, before considering a randomized controlled study. The administration of intra myocardial cells using the NOGA system was carried out to date with more than 1,000 patients and is considered feasible and safe. However, the investigators will assess very carefully the feasibility and safety of this invasive approach.
The primary endpoint is the improvement of myocardial perfusion measured by MRI after endomyocardial injection of mesenchymal cells by percutaneous way, guided by the NOGA system.
The secondary endpoints are the feasibility and safety of this administration, changes in ejection fraction measured by contrast echocardiography, changes in other MRI cardiac parameters (left ventricular volumes , intramyocardial fibrosis), the oxygen consumption during exercise, myocardial perfusion measured by SPECT. Other secondary endpoints are the evolution of the immune status, and histological criteria of myocardial biopsy.
Once the mapping performed, preparation is injected through another catheter (MYOSTAR injection catheter) which will also be guided by the Noga® system. This catheter may be positioned on the regions of interest (viable ischemic areas) and allow the injection of the quantity of CSM (40 million / ml) in 10 to 12 different injection points and injection volumes 0.3 ml for a total dose of 120 to 144 million cells.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac transplant patient whatever is his initial pathology
- •Coronary vasculopathy grade 3 (CAV3) defined by:
- •Stenosis > 50% of common-core (CT) or stenosis >70% of at least 2 or 3 main coronary arteries or stenosis > 70% on secondary branches of 3 territories.
- •Coronary vasculopathy grade 1 or 2 (CAV 1 or 2) associated with FELV (FEVG) dysfunction <45% or abnormality of completion of restrictive type.
- •Defect of drip on at least 2 segments/17 in stress MRI.
- •Fraction of ejection LV<50 measured on ultrasound examination or confusion of diastolic function defined by a restrictive mitral steam (E/A > 2 or E/A between 1 and 2 and deceleration time E < 150 ms) or left ventricular diastolic pressure measured during coronarography >16mg Hg .
- •Without sign of acute rejection at the time of inclusion.
- •Under an optimal medical treatment
- •Patient who have given his enlightened and signed consent
排除标准
- •Patients <18 ou >80 years
- •Acute coronary syndrome or revascularisation in the 3 last months
- •Acute cardiac rejection in the 3 last months
- •Atrial fibrillation
- •Claustrophobia or contraindication to MRI (ex:pace-maker), to contrast injection or adenosine.
- •Presence of a thrombus in the left cavities detected by ultra-sound examination or MRI realized before the injection..
- •Pregnant or breast-feeding woman
- •Woman old enough to reproduction without effective means of contraception during its participation in the study
- •Patient benefiting from a legal protective measure
- •HIV positive
- •Not membership in a national save insurance (beneficiary or legal successor)
- •Patients undergoing others biomedical research
- •Patient not understanding the procedure bound to the protocol
- •Bad adhesion to the protocol suspected by the investigator.
研究组 & 干预措施
Mesenchymal cell therapy
干预措施: Mesenchymal cell therapy (Biological)
结局指标
主要结局
myocardial perfusion measured in MRI.
时间窗: 6 months
次要结局
- complications of catheterization(6 months)
- systolic function(6 months)
- diastolic function(6 months)
- immunomodulation induced MSCs in the blood(6 months)
- immunomodulation induced MSCs in myocardial biopsy(6 months)
- complications of endomyocardial injection(6 months)