Status:
COMPLETED
Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy
Lead Sponsor:
Nasser Aghdami MD., PhD
Conditions:
Cardiomyopathy
Eligibility:
All Genders
1-16 years
Phase:
PHASE1
PHASE2
Brief Summary
According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in pediatric, new modality of treatment is emerging. There are some case reports of administration of stem cel...
Detailed Description
Dilated cardiomyopathy as the most common form of cardiomyopathy is a rare but life-threatening disorder in children. The primary cause of nearly 37 % of children with DCM was unknown at diagnosis. De...
Eligibility Criteria
Inclusion
- Age between 1-16 year(s)
- LVEF \<45% (echocardiography)
- Duration of diagnosis more than 3 months
- Resistance to Standard therapy more than 2 months
- Informed consent
Exclusion
- Congenital Heart Disease
- Active infection less than one month
- Dysrhythmia
- Cardiogenic shock
- Renal failure
- Immune Deficiency (Documentation)
- Terminal illness or malignancy(Documentation)
- TORCH (Documentation)
- Metabolic disorder (Documentation)
- Neuromuscular disorder (Documentation)
- Autoimmune disease (Documentation)
- Developmental delay
- Cytotoxic drugs
- Previous bone marrow transplant
- Contraindications to CMR such as metallic implants
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02256501
Start Date
June 1 2013
End Date
December 1 2016
Last Update
April 27 2017
Active Locations (1)
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1
Royan Institute
Tehran, Iran