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NCT04893629 Clinical Trial

New Horizons for the Treatment of Cardiomyopathy in Children

Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04893629
Other study ID # UDMS-Cardio-01-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2021
Est. completion date October 30, 2022

Study information
Verified date February 2023
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date October 30, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 14 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Syrian Arab Republic Children'S Hospital Damascus

Sponsors (1)
Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Left ventricle ejection fraction (LVEF) measured by echo (mono mode, 3 Dimentional) 6 months
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