New Horizons for the Treatment of Cardiomyopathy in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intervention group children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells |
Biological: mono nuclear cells injection
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
|
| Active Comparator: control group children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment |
Drug: Digoxin+furosemide+captopril
classical heart failure medical treatment
Other Names:
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Outcome Measures
Primary Outcome Measures
- Left ventricle ejection fraction (LVEF) [6 months]
measured by echo (mono mode, 3 Dimentional)
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children'S Hospital | Damascus | Syrian Arab Republic | 011 |
Sponsors and Collaborators
- Damascus University
Investigators
- Study Chair: samir srour, prof, membership of the French society of the pediatric cardiology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- -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
Publications
- 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. Review.
- 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. Review.
- 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. Review.
- 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.
- 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.
- UDMS-Cardio-01-2021