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:

  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.