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Clinical Trials/NCT02871466
NCT02871466
Unknown
Phase 4

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

University of Campania "Luigi Vanvitelli"2 sites in 1 country30 target enrollmentJanuary 2010

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
July 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (2)

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