XC001 Gene Therapy for Coronary Artery Disease (CAD) Patients Undergoing CABG
This study is testing a gene therapy called XC001 for people with coronary artery disease (CAD) who are having bypass surgery (CABG). The goal is to see if XC001 can help grow new blood vessels (angiogenesis) in heart areas that might not get enough blood flow after CABG. You would receive injections of either XC001 or a placebo (an inactive substance) during your CABG procedure. Researchers will use imaging tests to compare how well XC001 works against the placebo over 26 weeks. This study is for adults aged 18 to 80 who have CAD and are scheduled for CABG.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase 2 study involving about 116 participants. You would have an equal chance of receiving XC001 or a placebo.
- What's involved
- You would receive injections during your CABG procedure and have follow-up imaging tests at Weeks 12 and 26 after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 26 weeks after surgery, with a possible 26-week extension.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change from Baseline (Day 4-6 CMR) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery.Week 26
Endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden, as measured by the following: * Global and segmental perfusion measured as sum of 32 subsegmental American Heart Association (AHA) LV segments with myocardial ischemia at 12- and 26-weeks follow-up compared to baseline (defined as a subsegment with myocardial ischemia without subendocardial late gadolinium enhancement) * Segmental myocardial blood flow measuring extent of ischemic defect in each of 16 (combined subendocardial and subepicardial) AHA LV segments defined as below at 12 and 26 weeks follow-up compared with Baseline: * Segment is abnormal if one (subendocardial) or both subsegments are ischemic at Baseline * Segment is defined as improved at follow-up if one or both subsegments normalize To qualify for analysis of the primary endpoint, at least 3 of 32 subsegments will have will have to be ischemic on the baseline CMR.