Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy

The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy. Process: Primary Evaluation Clinical History Echocardiogram to evaluate ejection fraction and other parameters Signing of Informed Consent and clearing doubts Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml). Recovery room with family members while the cells are being processed in the Hematology Laboratory. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.

The Patient will receive standard surgical care, accompanied by a nurse at all times. Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).

Children which meet eligibility criteria and after being assessed, are stimulated with G-CSF, undergo bone marrow extraction and then have them applied directly to the coronary arteries through cardiac catheterization.

Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.

Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.

Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.

Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.

Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.

Inclusion Criteria: Ejection fraction less than 35 percent in echocardiogram More than 3 months with complete medical treatment without significant improvement Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers Exclusion Criteria: Not signing informed consent Active infection at enrolling time Inadequate G-CSF application