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

Theregen

Status and phase

Unknown

Phase 1

Conditions

Heart Failure

Treatments

Drug: Anginera, a human tissue replacement therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00364598

TI-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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