Clinical Trial: Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
Brief Summary:
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:
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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.