NCT03145402Unknown1 期
The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation 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20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 that a single intracoronary infusion of autologous bone marrow-mononuclear 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
- Ejection fraction changes(12 months)
- 6-minute walk test (6MWT)(12 months)
- Pro b-type natriuretic peptide (Pro-BNP) changes(12 months)
- NYHA functional class(12 months)
研究者
研究点 (1)
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