Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Status Suspended

Clinical Trial 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.

Clinical Trial Description

- 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01504594
Study type	Interventional
Source	Hospital Universitario Dr. Jose E. Gonzalez
Contact
Status	Suspended
Phase	Phase 1
Start date	January 2012
Completion date	August 2013

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