NCT03746938Unknown1 期
First Open-label Trial in Humans to Evaluate the Safety and Efficacy of Epicardial Delivery of Collagen Patches With Adipose-derived Stem Cells in Patients With Ischemic Heart Disease and Left Ventricular Dysfunction.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- Viscofan
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation.
研究概览
简要总结
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.
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
- •Men and women aged ≥18 years and ≤80 years.
- •LVEF ≤35% as assessed by echocardiography, confirmed by MRI if there are no contraindications for this procedure.
- •History of revascularised or nonrevascularisable coronary artery disease as the cause of ventricular dysfunction.
- •NYHA functional class III for dyspnea under optimal medical treatment.
- •Ability to perform the exercise test with respiratory gas consumption. MVO2 should be ≥ 10 and ≤ 18 ml/kg/min in the exercise test.
- •Ability to perform a 6-minute walk test > 100 m and ≤ 400 m.
- •Haemodynamic stability (blood pressure > 100/40 mmHg, heart rate < 110 bpm and oxygen saturation at rest in room air > 95%).
排除标准
- •Participation in another clinical trial within 30 days prior to inclusion.
- •Prior treatment with cell or gene therapy.
- •Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
- •Significant coronary artery disease eligible for revascularization.
- •Significant valvular disease eligible for surgery.
- •Presence of uncontrolled ventricular arrhythmias (VR or VF) at the time of implant surgery.
- •Women who are pregnant or breastfeeding.
- •Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent.
- •Advanced dementia according to the Barthel index.
- •Active systemic infection.
- •History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow-up).
- •Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated nonmelanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy) are permitted.
- •History of autoimmune disease.
- •Stroke within 12 months prior to inclusion.
- •Respiratory compromise or need for home oxygen therapy.
- •Life expectancy of less than 1 year for any reason.
研究组 & 干预措施
VB-C01
Experimental
Surgical technique: Via left lateral thoracotomy, the heart is lifted and supported on two deep pericardial points with 4-0 or 5-0 Prolene double arrmed suture. Each suture is passed through the reinforced frame of the collagen membrane containing the stem cells (VB-C01) and then tied, while the upper part of the patch is held with forceps. After securing the lower part of the pericardial layer, the heart is allowed to slowly recover its position with the pericardial cavity while the collagen membrane is mobilized to cover all of the target area. If necessary, some sutures can be used to fix the patch VB-C01 to the epicardial surface of the heart. Each suture is likewise passed through the reinforced frame of the membrane.
干预措施: VB-C01 (Device)
结局指标
主要结局
Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation.
时间窗: During the first year after implantation
MACCE include: all-cause death, cardiovascular death, re-infarction, need for revascularization, hospitalization for heart failure, sustained ventricular tachycardia, ventricular fibrillation, or stroke.
次要结局
- Incidence of all-cause death(During the first year after implantation)
- Incidence of cardiovascular death(During the first year after implantation)
- Incidence of re-infarction(During the first year after implantation)
- Incidence of need for revascularization(During the first year after implantation)
- Incidence of hospitalization for heart failure(During the first year after implantation)
- Incidence of sustained ventricular tachycardia(During the first year after implantation)
- Incidence of ventricular fibrillation(During the first year after implantation)
- Incidence of stroke(During the first year after implantation)
- Incidence of surgical complications(During the first year after implantation)
- Changes in the pericardial physiology(During the first year after implantation)
- VT inducibility(During the first year after implantation)
- Changes in DSA-HLA(During the first year after implantation)
- Changes in proinflammatory cytokines(During the first year after implantation)
- Changes in immunological cell types.(During the first year after implantation)
- Changes in end-systolic volume(During the first year after implantation)
- Changes in end-diastolic volume(During the first year after implantation)
- Changes in left ventricular ejection fraction(During the first year after implantation)
- Changes in sphericity index(During the first year after implantation)
- Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments(During the first year after implantation)
- Changes in systolic thickening by myocardial segments(During the first year after implantation)
- Changes in the scar size expressed in grams(During the first year after implantation)
- Changes in the viable myocardial mass expressed in grams(During the first year after implantation)
- Changes in the scar size expressed in percentage of LV(During the first year after implantation)
- Changes in the percentage of viable myocardium in LV(During the first year after implantation)
- Changes in the functional class(During the first year after implantation)
- Changes in the patient-perceived quality of life(During the first year after implantation)
- Changes in the distance covered on the 6-minute walk test(During the first year after implantation)
- Changes in the peak oxygen consumption on ergospirometry(During the first year after implantation)
- Changes in the brain natriuretic peptide(During the first year after implantation)
研究者
研究点 (4)
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