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New Horizons for the Treatment of Cardiomyopathy in Children

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893629
Enrollment
22
Registered
2021-05-19
Start date
2021-05-20
Completion date
2024-11-30
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

Keywords

Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells

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 .

Interventions

BIOLOGICALmono nuclear cells injection

trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group

DRUGDigoxin+furosemide+captopril

classical heart failure medical treatment

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Left ventricle ejection fraction (LVEF)6 monthsmeasured by echo (mono mode, 3 Dimentional)

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026