New Horizons for the Treatment of Cardiomyopathy in Children
NCT ID: NCT04893629
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2021-05-20
2024-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intervention group
children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells
mono nuclear cells injection
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
control group
children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment
Digoxin+furosemide+captopril
classical heart failure medical treatment
Interventions
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mono nuclear cells injection
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
Digoxin+furosemide+captopril
classical heart failure medical treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* LVEF less than 40%
* Use of I.V inotropes
Exclusion Criteria
* Severe organ failure (other than the heart)
6 Months
14 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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samir srour, prof
Role: STUDY_CHAIR
membership of the French society of the pediatric cardiology
Locations
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Children'S Hospital
Damascus, , Syria
Countries
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References
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Selem SM, Kaushal S, Hare JM. Stem cell therapy for pediatric dilated cardiomyopathy. Curr Cardiol Rep. 2013 Jun;15(6):369. doi: 10.1007/s11886-013-0369-z.
Zeinaloo A, Zanjani KS, Bagheri MM, Mohyeddin-Bonab M, Monajemzadeh M, Arjmandnia MH. Intracoronary administration of autologous mesenchymal stem cells in a critically ill patient with dilated cardiomyopathy. Pediatr Transplant. 2011 Dec;15(8):E183-6. doi: 10.1111/j.1399-3046.2010.01366.x. Epub 2010 Sep 29.
Vrtovec B, Poglajen G, Lezaic L, Sever M, Domanovic D, Cernelc P, Socan A, Schrepfer S, Torre-Amione G, Haddad F, Wu JC. Effects of intracoronary CD34+ stem cell transplantation in nonischemic dilated cardiomyopathy patients: 5-year follow-up. Circ Res. 2013 Jan 4;112(1):165-73. doi: 10.1161/CIRCRESAHA.112.276519. Epub 2012 Oct 12.
Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. doi: 10.1001/archinte.167.10.989.
Mozid AM, Arnous S, Sammut EC, Mathur A. Stem cell therapy for heart diseases. Br Med Bull. 2011;98:143-59. doi: 10.1093/bmb/ldr014. Epub 2011 May 19.
Related Links
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-Wang et al. Stem Cell Research \& Therapy (2019) 10:137
I. M-Behnke et al. Regenerative therapies in young hearts with structural or congenital heart disease
Other Identifiers
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UDMS-Cardio-01-2021
Identifier Type: -
Identifier Source: org_study_id
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