The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy
- Conditions
- Cardiomyopathy.Dilated cardiomyopathyI42.0
- Registration Number
- IRCT20100212003331N2
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ejection fraction. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Echocardiography.;6 Min walk test. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Test in pediatric cardiology ward.;Speckle echocardiography. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: echocardiography.
- Secondary Outcome Measures
Name Time Method