Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Diagnosis of DCM according to European Society of Cardiology position statement
- •Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
- •New York Heart Association (NYHA) functional class heart failure II or III for at least 3 months before referral.
排除标准
- •Acute multi-organ failure
- •History of any malignant disease within 5 years
- •Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
- •Pregnancy
研究组 & 干预措施
Group A
Repetitive stem cell administration
干预措施: Stem cell therapy (Biological)
Group B
Single stem cell administration
干预措施: Stem cell therapy (Biological)
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: baseline and 1 year
The echocardiography data will be recorded and analyzed at the end of the study by an independent echocardiographer who will be blinded to the patient's treatment status and the timing of the recordings. Left ventricular end-systolic volume and end-diastolic volume and LVEF will be estimated using the Simpson's biplane method and left ventricular end-systolic dimension and end-diastolic dimension will be measured in the parasternal long axis view. All echocardiographic measurements will be averaged for 5 cycles.. The change in left ventricular ejection fraction (LVEF) between randomization and 1 year thereafter will be assessed by 2D echocardiography.
次要结局
- Changes in regional wall motion(baseline and 1 year)
- Change in NT-proBNP(baseline and 1 year)
- Change in left ventricular dimension(1 year)
- Change in exercise capacity(baseline and 1 year)
研究者
Bojan Vrtovec
Medical Director, Advanced Heart Failure and Transplantation
University Medical Centre Ljubljana