跳至主要内容
临床试验/NCT04893629
NCT04893629终止不适用

The Effectiveness of Autologous Mono Nuclear Cells in the Treatment of Dilated Cardiomyopathy in Children

Damascus University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
1
主要终点
Left ventricle ejection fraction (LVEF)

研究概览

简要总结

Collecting mono nuclear cells from the patient's blood after a course of granulocyte stimulation then injecting them into the weak heart muscle measuring the heart function at the beginning and after 2.4.6 months to assess the improvement due to this procedure, by comparing these patients to patients with the same condition treated the classic way.

详细描述

Dilated cardiomyopathy in children has high morbidity and mortality, current treatment doesn't improve the prognosis and the only cure available is heart transplantation which is limited, has long waiting list (if available), high cost, and has many side effects, leading to the need of novel effective, less costly therapeutic alternatives.

Stem cell therapy has proven to improve the cardiac function, reverse the pathologic histological changes, decrease the morbidity and mortality, offering a possible replacement to heart transplantation, different reports proved the safety and efficacy of this therapy using different types of cells and different routs of application in cardiomyopathy and acute myocardial infarction in children and adults, and in congenital heart disease, but the published cases of this therapy conducted on children with dilated cardiomyopathy are scanty .

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
None

入排标准

年龄范围
6 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago
  • LVEF less than 40%
  • Use of I.V inotropes

排除标准

  • Acute infection
  • Severe organ failure (other than the heart)

研究组 & 干预措施

control group

Active Comparator

children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment

干预措施: Digoxin+furosemide+captopril (Drug)

intervention group

Experimental

children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells

干预措施: mono nuclear cells injection (Biological)

结局指标

主要结局

Left ventricle ejection fraction (LVEF)

时间窗: 6 months

measured by echo (mono mode, 3 Dimentional)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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