The Effect of Cyanophyta Aphanizomenon Flos-aquae (Stemregen), and Adipose Stroma Vascular Fraction (SVF) Either Individual or in Combination in Patient With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]
研究概览
简要总结
This study is a prospective, randomized, controlled trial to assess the efficacy of transplantation of autologous stroma vauscultar fraction and/or AFA in 15 patients with ischemic heart failure
详细描述
Stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, and a previous history of coronary artery diseases. In this study the investigators have evaluated consecutive 15 selected patients, the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, serum of Natriuretic peptide level and associated to reduction of angina after a treatment with stroma vascular fraction infusion y/or Stemregen capsule per oral.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EF < 45 %
- •NYHA 2 - 3
排除标准
- •Acute coronary syndrome within last 6 weeks.
- •Pregnancy
- •FEV1 <20 %
- •Any severe disease which could interfere with the treatment or the outcome
- •Patient with immunodeficiency
- •Candidate who are judged to be not applicable to this study by doctors.
结局指标
主要结局
Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]
时间窗: 6 months
Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension. \[ Time Frame: 6 months from trial admission\]
Change NYHA functional class assessed with SAQ-7 -questionnaire
时间窗: 6 month
The improvement in patient's quality of life after 6 months of trial admission. The quality of life will be determined with Seattle Angina Questionnaire 7 (SAQ-7). Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality)
次要结局
- Change NYHA functional class assessed with SAQ-7 -questionnaire(12 months)
- Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ](12 months)