New Horizons for the Treatment of Cardiomyopathy in Children

Damascus University

Status: Terminated

Conditions: Cardiomyopathy

Treatments: Drug: Digoxin+furosemide+captopril; Biological: mono nuclear cells injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04893629

UDMS-Cardio-01-2021

Details and patient eligibility

About

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.

Full description

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 .

Enrollment: 22 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

Biological: mono nuclear cells injection

control group

Active Comparator group

Description:

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

Treatment:

Drug: Digoxin+furosemide+captopril