Stem Cells Therapy in Advanced Heart Failure

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871466
• Other study ID #: 8.2016
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Raffaele Marfella, MD, PhD
• Phone: 00390815566101
• Email: raffaele.marfella[@]unicampania.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• stem cells infusion

Locations

Country	Name	City	State
Italy	Celestino Sardu	Naples
Italy	Raffaele Marfella	Naples
Italy	Celestino Sardu	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NYHA class improvement		12 months
Primary	reduction in hospitalization rate		12 months
Primary	reduction in angor symptoms		12 months