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

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ClinicalTrials.gov Identifier: NCT00364598
Recruitment Status : Unknown
Verified March 2009 by Theregen, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2006
Last Update Posted : March 30, 2009
Sponsor:
Information provided by:
Theregen, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Anginera, a human tissue replacement therapy Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : November 2008
Estimated Study Completion Date : February 2009



Primary Outcome Measures :
  1. 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 :
  1. Safety


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Gary Gentzkow, M.D. Chief Medical Officer, Theregen, Inc.
ClinicalTrials.gov Identifier: NCT00364598     History of Changes
Other Study ID Numbers: TI-102
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

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