Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • Change in global left ventricular ejection fraction
研究概览
简要总结
The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.
详细描述
Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase.
Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure patients in dilated stages
- •Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
- •Ejection fraction ≤ 40%.
- •Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization
排除标准
- •Severe or persistent heart failure
- •Recurrent myocardial ischemia
- •Uncontrolled ventricular tachycardia
- •Malignant disease (life expectancy of less than one year)
- •Manifest ventricular asynchrony
- •Hematologic disease
- •Recent cerebrovascular disease
- •Recent acute coronary syndrome
- •Serum creatinine >2.26 mg/dL (200 umol/L)
- •Atrial fibrillation without heart rate control in the last 3 months
结局指标
主要结局
• Change in global left ventricular ejection fraction
时间窗: 3, 6, 12 months
次要结局
- • Change in functional capacity measured in O2 consumption(0, 3, 6, 12 months)
- • Occurrence of major adverse cardiac event(12 months)
- • Change in high sensitivity C-reactive protein (hs CRP)(0, 3, 6, 12 months)
- • Reduction in level of B-type natriuretic peptide (BNP)(0, 3, 6, 12 months)
研究者
Jorge Bartolucci
Medical director of Celular Therapy
Universidad de los Andes, Chile