NCT02871466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

12 years

First QC Date

August 10, 2016

Last Update Submit

August 11, 2020

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (3)

  • NYHA class improvement

    12 months

  • reduction in hospitalization rate

    12 months

  • reduction in angor symptoms

    12 months

Study Arms (1)

stem cells infusion

EXPERIMENTAL
Drug: stem cells infusion

Interventions

stem cells infusionDRUG
stem cells infusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.

You may not qualify if:

  • inflammatory chronic diseases, neoplastic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Celestino Sardu

Naples, 80131, Italy

RECRUITING

Raffaele Marfella

Naples, 80138, Italy

RECRUITING

Celestino Sardu

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Raffaele Marfella, MD, PhD

CONTACT

00390815566101raffaele.marfella@unicampania.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 18, 2016

Study Start

January 1, 2010

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)