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.
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 ]
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 ]
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