Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)


Trial ID: NCT04125732


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).

Official Title

A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris

Stanford Investigator(s)

Juyong Brian Kim
Juyong Brian Kim

Assistant Professor of Medicine (Cardiovascular Medicine)


Inclusion Criteria:

   - Males and females, age 18 to 80 years

   - Diagnosis of chronic angina due to obstructive coronary artery disease that is
   refractory to drug therapy and unsuitable for revascularization via coronary artery
   bypass graft or percutaneous coronary intervention

   - Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina

   - Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count > 1.2 × 10^3 per
   μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and
   aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function
   (glomerular filtration rate > 29 mL/minute/1.73 m2)

   - Adequate birth control if of child-bearing potential

   - Must be willing and able to provide informed consent

Exclusion Criteria:

   - ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction
   (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral
   vascular accident within the past 30 days

   - New York Heart Association Function Class III or IV or left ventricular ejection
   fraction < 25% within the 6 weeks prior to the screening visit

   - HbA1c ≥ 8.5%, SBP <90 or >180 mmHg, DBP >100 mmHg

   - Other concurrent medical conditions that could jeopardize the safety of the subject or
   objectives of the study


biological: AdVEGFXC1


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kokil Bakshi