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Trial record 3 of 210 for:    stem+cell+AND+failing

Stem Cells Therapy in Advanced Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02871466
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : August 13, 2020
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: stem cells infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: stem cells infusion Drug: stem cells infusion

Primary Outcome Measures :
  1. NYHA class improvement [ Time Frame: 12 months ]
  2. reduction in hospitalization rate [ Time Frame: 12 months ]
  3. reduction in angor symptoms [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02871466

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Contact: Raffaele Marfella, MD, PhD 00390815566101

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Celestino Sardu Recruiting
Naples, Italy, 80131
Contact: Raffaele Marfella         
Raffaele Marfella Recruiting
Naples, Italy, 80138
Contact: Raffaele Marfella, MD, PhD    +39 0810815665110   
Contact: Celestino Sardu, MD, MSc, PhD    +393336664543   
Celestino Sardu Recruiting
Napoli, Italy
Contact: Raffaele Marfella         
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Responsible Party: Celestino Sardu, principal investigator, University of Campania "Luigi Vanvitelli" Identifier: NCT02871466    
Other Study ID Numbers: 8.2016
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases