Cardiomyopathy Clinical Trial
Official title:
The Effectiveness of Autologous Mono Nuclear Cells in the Treatment of Dilated Cardiomyopathy in Children
Verified date | February 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Children'S Hospital | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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
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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