New Horizons for the Treatment of Cardiomyopathy in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

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

Conditions
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Cardiomyopathy

Intervention / Treatment
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* Biological: mono nuclear cells injection
* Drug: Digoxin+furosemide+captopril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago LVEF less than 40% Use of I.V inotropes Exclusion Criteria: Acute infection Severe organ failure (other than the heart)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells | Biological: mono nuclear cells injection<br>* trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group<br>|
| Active Comparator: control group<br>children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment | Drug: Digoxin+furosemide+captopril<br>* classical heart failure medical treatment<br>* Other names: lasix,capoten;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle ejection fraction (LVEF) | measured by echo (mono mode, 3 Dimentional) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells