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Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant | Clinical Trials | Clareo Health

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Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant

A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera™ in Adults With A Left Ventricular Assist Device As A Bridge To Transplant

NCT00364598•Theregen, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.

Detailed Description

This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stage D Heart Failure
•Patients having an LVAD implanted as a bridge to transplant.

Exclusion Criteria

•Biopsy proven acute myocarditis
•Known Giant Cell Myocarditis
•Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease

Locations (3)

Yale University School of Medicine

New Haven, Connecticut, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

November 1, 2008

Completion Date

February 1, 2009

Last Updated

March 30, 2009

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

Anginera, a human tissue replacement therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant

Inclusion Criteria

Exclusion Criteria

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