New Horizons for the Treatment of Cardiomyopathy in Children

Not Applicable

Terminated

• Conditions: Cardiomyopathy
• Interventions: Biological: mono nuclear cells injection; Drug: Digoxin+furosemide+captopril

• Registration Number: NCT04893629
• Lead Sponsor: Damascus University

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-19
• Study Start: 2021-05-20
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	mono nuclear cells injection	children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells
control group	Digoxin+furosemide+captopril	children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment

Primary Outcome Measures

Name	Time	Method
Left ventricle ejection fraction (LVEF)	6 months	measured by echo (mono mode, 3 Dimentional)

Trial Locations

Locations (1)

Children'S Hospital; 🇸🇾 Damascus, Syrian Arab Republic