Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment anginera, a human tissue replacement therapy
Phase phase 1
Sponsor Theregen, Inc.
Start date April 2006
End date November 2008
Trial size 12 participants
Trial identifier NCT00364390, ITT-101

Summary

This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Physical exam and interval medical history
time frame:
CBC and differential
time frame:
Serum cardiac markers—Troponin I
time frame:
Serum chemistries and urinalysis
time frame:
Resting electrocardiogram (ECG)
time frame:
24 hour Holter monitor
time frame:
Adverse Events reporting
time frame:

Eligibility Criteria

Male or female participants from 35 years up to 80 years old.

Inclusion Criteria: - Patients have been referred for CABG - Left ventricular ejection fraction (LVEF) greater than 20% - Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI - There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Patient undergoing valve replacement or valve modification 2. Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.) 3. Patient requires urgent coronary artery bypass surgery

Additional Information

Official title A Phase I Open Label Pilot Study to Evaluate the Safety, Efficacy and Tolerability of Anginera for Adults With Left Ventricular Dysfunction AND Reversible Myocardial Ischemia Undergoing CABG Surgery
Principal investigator Bartley P Griffith, MD
Description A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted. The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Theregen, Inc..