Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy
Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy
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 cell therapy. The investigators design the first randomized clinical
 trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16
 pts. in each group including cell therapy and control). The investigators assess the safety
 and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear
 cells in this patients compared to control group.
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. Despite of the developing in the medical and surgical treatment
 during the past several decades, standard treatments (including Digitalis, diuretics,
 inhibitors of ACE, beta blockers, antiplatelet drugs and treatments Antiarrhythmic), may
 stabilize the condition, but will not restore heart function to its previous condition.
 Therapy remains complex and expensive. For some not all children the heart transplantation is
 only option and mortality continues to be high, also. Stem cell and cell-based therapies
 offer an innovative approach to reverse cardiac structure and function towards normal,
 possibly reducing the need for aggressive therapies and cardiac transplantation. According to
 the inclusion and exclusion criteria of trial, 32 patients with left ventricular ejection
 fraction less than 45% who resistance to the standard medical therapy were randomly allocated
 in 2 groups including BM-derived mononuclear (n=16) and control (n=16). Only the MNC group
 underwent the bone marrow aspiration and intracoronary injection. The investigators followed
 all of patients at 2 weeks, 1, 2, 4 and 6 months after transplantation for cell therapy group
 or registration for placebo by physical examination, laboratory tests and imaging such as
 echocardiography, CXR and CMR.
Inclusion Criteria:

 1. Age between 1-16 year(s)

 2. LVEF <45% (echocardiography)

 3. Duration of diagnosis more than 3 months

 4. Resistance to Standard therapy more than 2 months

 5. Informed consent

 Exclusion Criteria:

 1. Congenital Heart Disease

 2. Active infection less than one month

 3. Dysrhythmia

 4. Cardiogenic shock

 5. Renal failure

 6. Immune Deficiency (Documentation)

 7. Terminal illness or malignancy(Documentation)

 8. TORCH (Documentation)

 9. Metabolic disorder (Documentation)

 10. Neuromuscular disorder (Documentation)

 11. Autoimmune disease (Documentation)

 12. Developmental delay

 13. Cytotoxic drugs

 14. Previous bone marrow transplant

 15. Contraindications to CMR such as metallic implants