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: 1. Primary Evaluation * Clinical History * Echocardiogram to evaluate ejection fraction and other parameters 2. Signing of Informed Consent and clearing doubts 3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously 4. 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). 5. Recovery room with family members while the cells are being processed in the Hematology Laboratory. 6. 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. 7. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids. 8. 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University Hospital Dr. Jose E. Gonzalez
Monterrey, N.l., Mexico
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.
Time frame: 6 weeks
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.
Time frame: 6 months
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