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
Recruitment status was Active, not recruiting
Sponsor:
Theregen, Inc.
Information provided by:
Theregen, Inc.
ClinicalTrials.gov Identifier:
NCT00364598
First received: August 14, 2006
Last updated: March 27, 2009
Last verified: March 2009
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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 |
Resource links provided by NLM:
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) |
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:
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 May 23, 2013