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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2023-05-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Ischemia Angina Refractory Cardiovascular Diseases Heart Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

AdVEGFXC1 at one of 4 doses

Intervention Type BIOLOGICAL

Other Intervention Names

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XC001

Eligibility Criteria

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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 Pectoris
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No