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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Theregen, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Theregen, Inc.
ClinicalTrials.gov Identifier:
NCT00364598
First received: August 14, 2006
Last updated: March 27, 2009
Last verified: March 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Theregen, Inc.:
Anginera
LVAD
Transplant
Histology
LVAD implantation as a bridge to transplant

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014