Stem Cells Therapy in Advanced Heart Failure

NCT ID: NCT02871466

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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stem cells infusion

Group Type EXPERIMENTAL

stem cells infusion

Intervention Type DRUG

Interventions

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stem cells infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Celestino Sardu

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Celestino Sardu

Naples, , Italy

Site Status RECRUITING

Raffaele Marfella

Naples, , Italy

Site Status RECRUITING

Celestino Sardu

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Raffaele Marfella, MD, PhD

Role: CONTACT

00390815566101

Facility Contacts

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Raffaele Marfella

Role: primary

Raffaele Marfella, MD, PhD

Role: primary

+39 0810815665110

Celestino Sardu, MD, MSc, PhD

Role: backup

+393336664543

Raffaele Marfella

Role: primary

Other Identifiers

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8.2016

Identifier Type: -

Identifier Source: org_study_id

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