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Stem Cells Therapy in Advanced Heart Failure

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02871466
Enrollment
30
Registered
2016-08-18
Start date
2010-01-31
Completion date
2022-07-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

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.

Interventions

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
NYHA class improvement12 months
reduction in hospitalization rate12 months
reduction in angor symptoms12 months

Countries

Italy

Contacts

Primary ContactRaffaele Marfella, MD, PhD
raffaele.marfella@unicampania.it00390815566101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026