Overview

This trial is active, not recruiting.

Condition heart failure
Treatment anginera, a human tissue replacement therapy
Phase phase 1
Sponsor Theregen, Inc.
Start date December 2006
End date November 2008
Trial size 15 participants
Trial identifier NCT00364598, TI-102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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.
time frame:

Secondary Outcomes

Measure
Safety
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Kenneth B Margulies, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Theregen, Inc..