Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02871466
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2016-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cells Therapy in Advanced Heart Failure
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: