Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Instituto de Cardiologia do Rio Grande do Sul2 个研究点分布在 1 个国家目标入组 6 人开始时间: 2004年4月1日最近更新: 2008年2月14日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 6
试验地点: 2
主要终点: safety: morbidity/mortality

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
•left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
•age below 60 years
•absence of neoplasm
•absence of hematologic disease or systemic disease
•no previous cardiac intervention

排除标准

•episodes of tachycardia or ventricular fibrillation
•severe or moderated mitral insufficiency
•any other valvulopathies

结局指标

主要结局

safety: morbidity/mortality

时间窗: eighteen months

次要结局

未报告次要终点

研究者

发起方

Instituto de Cardiologia do Rio Grande do Sul

申办方类型

Other

研究点 (2)

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