Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue (The PERISCOPE Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation.
研究概览
简要总结
Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today, there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and in more advanced stages the only therapy that completely restores cardiac function is heart transplantation.
Mesenchymal stem cells are multipotent cells found from embryonic mesoderm and found in all tissues. In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. Our approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.
详细描述
Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and, in more advanced stages, the only therapy that completely restores cardiac function is heart transplantation.
Experimental studies are evaluating new therapeutic approaches based on tissue engineering for myocardial regeneration. Cardiac tissue engineering attempts to create functional tissue constructs that can restore the structure and function of damaged myocardium.
Mesenchymal stem cells (MSCs) are multipotent cells that develop from embryonic mesoderm and are found in all structural tissues of the body.
In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. The investigators approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.
Among the different types of MSC currently available, the investigators propose the use of those derived from the connective tissue surrounding the great vessels (2 arteries and one vein) of the umbilical cord called Wharton's gelatin (MSC, WJ) whose immunomodulatory properties are described extensively in the literature. These MSC, WJ cells have a PEI approved by the Spanish Agency for Medicines and Healthcare Products (AEMPS) (PEI 16-017) that guarantees an optimal manufacturing process for a clinical trial.
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 (Participant, Investigator)
盲法说明
The randomization will be known exclusively by the cardiac surgery team and the study coordinator, and it will be blind to the patient and to the rest of the investigators team: clinical cardiologist who performs the follow-up, team that performs image tests, core lab that evaluates the imaging tests and the equipment that statistically analyzes the data.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction of ≥50% of transmurally due to MR
- •Candidate for coronary by-pass through that or another territory
- •Age ≥18 years
- •Signature of informed consent
- •Wave Q present in the ECG
- •Followed by the cardiology service of Germans Trial i Pujol hospital
排除标准
- •Severe valvular disease with indication of surgical repair
- •Candidate for ventricular remodeling
- •Contraindication for MR (creatinine clearance less than 30 ml / min / 1.73m2, metallic implant carriers, claustrophobia)
- •Extracardiac disease with estimated life expectancy less than 1 year
- •Neoplastic disease detected in the last five years or without complete remission
- •Severe renal or hepatic insufficiency
- •Abnormal laboratory values, not explainable at the time of inclusion, and that at the discretion of the investigator contraindicate the patient's participation in the study
- •Patients with a previous cardiac intervention
- •Women who are pregnant or breast-feeding.
- •Women of childbearing age who are heterosexually active and who do not use an effective contraceptive method from 14 days before the inclusion in the study and at least up to 12 weeks after the end of the study.
- •Simultaneous participation in another clinical trial or treatment with another product in investigational phase in the 30 days prior to inclusion in the study.
- •Negation of the patient to be followed by a period that exceeds the clinical trial itself (long-term follow-up in the second and third year).
结局指标
主要结局
Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation.
时间窗: at 12 months of follow-up
Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment.
次要结局
- Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation.(At 1 week, 3 and 6 months)
- Changes of regional contractility(At 3 and 12 months)
- Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin I (hsTnI) levels(At 1 week, 3 and 12 months)
- Changes in ejection fraction of the left ventricle(At 3 and 12 months)
- Changes in the score on the quality of life test Short Form 36 Healthy Survey (SF-36).(At 3 and 12 months)
- changes in left and right ventricular geometric remodeling(At 3 and 12 months)
- Death rate or rehospitalization due to cardiovascular causes(At 1 week, 3 , 6and 12 months)
- Changes in the necrotic myocardial mass ratio(At 3 and 12 months)
- Rate of relevant arrhythmias in Holter of 24 hours(At 1 week, 3 and 12 months)
- Changes in the score on the quality of life Kansas City Cardiomyopathy Questionnaire (KCCQ) test in cases of participants with heart failure will be used.(At 3 and 12 months)