NCT03227198Unknown1 期
Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients
SCARM Institute, Tabriz, Iran1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年10月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of any ethnic origin 18 ≤ aged≤ 65 years
- •EF≤40 (by Echocardiography) and regional wall motion abnormality
- •Not responding to standard therapies
- •the New York Heart Association (NYHA) class ≥ III
- •Myocardial infarction due to coronary artery atherosclerotic disease
- •An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
- •Normal liver and renal function
- •No or controlled diabetes
- •Able to give voluntary written consent and understand the study information provided to him
排除标准
- •Participation in another clinical trial within 30 days prior randomisation
- •Previously received stem/progenitor cell therapy
- •Pregnant women
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- •Cardiogenic shock requiring mechanical support
- •Congenital / valvular heart disease
- •Implantable cardioverter defibrillator (ICD) transplant
- •Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
- •Impaired renal function, i.e. creatinine >2.5 mg/dl
- •Fever or diarrhea within 4 weeks prior screening
- •History of bleeding disorder within 3 months prior screening
- •Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia
- •Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
结局指标
主要结局
Death
时间窗: 12 months
The rate of patients mortality after transplantation
Hospitalization
时间窗: 12 months
the rate of hospitalization after transplantation
次要结局
- NYHA functional class(12 months)
- Ejection fraction changes(12 months)
- 6-minute walk test (6MWT)(12 months)
- Pro b-type natriuretic peptide (Pro-BNP) changes(12 months)
研究者
研究点 (1)
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