The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
AdVEGFXC1 at one of 4 doses
Stanford University
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Cardiology Research Associates
Daytona Beach, Florida, United States
University of Florida
Gainesville, Florida, United States
James A. Haley VA Medical Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Duke University
Durham, North Carolina, United States
The Christ Hospital / The Lindner Research Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
...and 6 more locations
Primary Endpoint (adverse events)
Safety, as assessed by adverse events and serious adverse events
Time frame: 6 months
Secondary Endpoint (Exercise tolerance test)
Exercise tolerance test
Time frame: 6 months
Secondary Endpoint (Seattle Angina Questionnaire)
Seattle Angina Questionnaire
Time frame: 6 months
Secondary Endpoint (Canadian Cardiovascular Society angina class)
Canadian Cardiovascular Society angina class
Time frame: 6 months
Secondary Endpoint (Angina episodes)
Angina episodes
Time frame: 6 months
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