The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy (The third phase of clinical trial)

Shiraz University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•Age between 1 to 18 years
•- Definitive diagnosis of dilated cardiomyopathy without a treatable cause (arrhythmia - ALCAPA - tumors, etc.)
•Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4
•Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4- Normal kidney function and no serious functional liver damage (INR> 2 - Alb <3 - AST, ALT more than 3 times of Nl Range).
•- no hematological disorders
•No syndromic diseases
•Accepting the participation form in the study and being aware of the side effects of this treatment
•- If the initial response is appropriate, increase the EF by 5% in the first injection of the second injection, 3 months after the first injection.

•Non-compliance with any of the entry conditions at each stage of the study before stem cell injection
•Not accepting the informed consent form to participate in the study or performing cardiac angiography.
•Appropriate response to oral antifailure treatment
•Active infection
•Less than 6 months have passed since the diagnosis of dilated cardiomyopathy
•Existence of refractory arrhythmia due to dilated cardiomyopathy
•Existence of bleeding and serious coagulation disorder

发起方