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

Sponsored by:	Theregen, Inc.
Information provided by:	Theregen, Inc.
ClinicalTrials.gov Identifier:	NCT00364598

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: Anginera, a human tissue replacement therapy	Phase I

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by Theregen, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Safety

Estimated Enrollment:	15
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364598

Locations

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Theregen, Inc.

Investigators

Principal Investigator:	Kenneth B Margulies, M.D.	University of Pennsylvania
Principal Investigator:	Y. Joseph Woo, M.D.	University of Pennsylvania

More Information

Additional Information:

Theregen website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Theregen, Inc. ( Gary Gentzkow, M.D. Chief Medical Officer )
Study ID Numbers:	TI-102
Study First Received:	August 14, 2006
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00364598 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theregen, Inc.:

Anginera
LVAD
Transplant
Histology
LVAD implantation as a bridge to transplant

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009