Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02256501|
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy||Biological: Mono Nuclear Cell (MNC) transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Intracoronary Transplantation of Autologous Bone Marrow Derived Mononuclear Cells (MNC) in Idiopathic Dilated Cardiomyopathy in Pediatric Patients: Clinical Trial Phase I/II|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Mono Nunlear Cell (MNC)
The patients with idiopathic dilated cardiomyopathy who underwent intracoronary injection of autologous bone marrow-derived mononuclear cells .
Biological: Mono Nuclear Cell (MNC) transplantation
Intracoronary administration of autologous bone marrow derived mononuclear cells
No Intervention: Control
The patients with cardiomyopathy that are under observe during the study.
- Death [ Time Frame: 3months ]The rate of patients' death 3 months after cell transplantation
- Arrest [ Time Frame: 3 months ]The rate of patients' arrests 3 months after cell transplantation
- Dysrhythmia [ Time Frame: 3 months ]The rate of dysarthymia 3 months after cell transplantation
- Heart transplantation [ Time Frame: 3 months ]The rate of demand for heart transplantation 3 months after cell transplantation.
- Hospital admission for heart failure [ Time Frame: 3 months ]The rate of hospital administration 3 months after cell transplantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256501
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute|
|Study Director:||Mohammad Mahdavi, MD||Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran|
|Principal Investigator:||Koorosh Vahidshahi, MD||Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran|