Trials / Terminated
TerminatedNCT04893629
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Damascus University · Academic / Other
- Sex
- All
- Age
- 6 Months – 14 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mono nuclear cells injection | trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group |
| DRUG | Digoxin+furosemide+captopril | classical heart failure medical treatment |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
- First posted
- 2021-05-19
- Last updated
- 2025-02-20
Locations
1 site across 1 country: Syria
Source: ClinicalTrials.gov record NCT04893629. Inclusion in this directory is not an endorsement.