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.

Detailed Summary:

  • 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).

Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome: Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 months ]

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


Original Secondary Outcome: Same as current

Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: December 15, 2011
Date Started: January 2012
Date Completion: August 2013
Last Updated: August 6, 2013
Last Verified: August 2013