Status:
SUSPENDED
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Cardiomyopathy, Dilated
Eligibility:
All Genders
1-16 years
Phase:
PHASE1
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...
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 (antiv...
Eligibility Criteria
Inclusion
- Ejection fraction less than 35 percent in echocardiogram
- More than 3 months with complete medical treatment without significant improvement
- Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers
Exclusion
- Not signing informed consent
- Active infection at enrolling time
- Inadequate G-CSF application
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01504594
Start Date
January 1 2012
End Date
August 1 2013
Last Update
August 9 2013
Active Locations (1)
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1
University Hospital Dr. Jose E. Gonzalez
Monterrey, N.l., Mexico, 64460