NCT01504594

Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Cardiomyopathy, Dilated

Interventions

Type	Name	Description
PROCEDURE	Intracoronary autologous stem cell infusion	Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-01-05
• Last updated: 2013-08-09

Locations

1 site across 1 country: Mexico