Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients
Overview
- Phase
- Phase 4
- Intervention
- stem cells infusion
- Conditions
- Congestive Heart Failure
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- reduction in angor symptoms
- Last Updated
- 5 years ago
Overview
Brief Summary
stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.
Investigators
Celestino Sardu
principal investigator
University of Campania "Luigi Vanvitelli"
Eligibility Criteria
Inclusion Criteria
- •heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.
Exclusion Criteria
- •inflammatory chronic diseases, neoplastic diseases.
Arms & Interventions
stem cells infusion
Intervention: stem cells infusion
Outcomes
Primary Outcomes
reduction in angor symptoms
Time Frame: 12 months
NYHA class improvement
Time Frame: 12 months
reduction in hospitalization rate
Time Frame: 12 months