XC001 Gene Therapy for Coronary Artery Disease
(EXACT-CABG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a new gene therapy treatment, XC001, for individuals with coronary artery disease (CAD) who require heart surgery but may not have all blocked arteries fully repaired. The study compares XC001 to a placebo to determine if it can improve blood flow to heart areas that regular surgery might not address. Candidates for the trial have significant CAD and are scheduled for heart bypass surgery (CABG), particularly if some heart areas won't benefit from surgery due to complex blockages. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in CAD treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that XC001 is likely to be safe for humans?
Previous studies have shown that XC001 is safe and generally well tolerated. Research involving 32 patients found that the gene therapy XC001 did not cause any serious side effects. During treatment, patients did not experience major negative reactions. XC001 is a gene therapy designed to improve blood flow to the heart by harnessing the body's natural processes. While results so far are promising, each person's experience may differ. Discuss any concerns about joining a trial with a healthcare professional.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about XC001 because it offers a novel approach to treating coronary artery disease. Unlike traditional treatments such as medications, lifestyle changes, or surgical interventions like angioplasty and coronary artery bypass grafting (CABG), XC001 is a gene therapy designed to enhance blood vessel growth. This new method targets the root cause of reduced blood flow by promoting angiogenesis, potentially improving heart function and reducing symptoms more effectively than conventional options. This innovative approach could lead to a more sustainable and long-term solution for patients, setting it apart from current treatment strategies.
What evidence suggests that XC001 might be an effective treatment for coronary artery disease?
Research has shown that XC001 gene therapy might alleviate symptoms of coronary artery disease (CAD). In one study, patients who received XC001 exercised longer, experienced better blood flow to their hearts, and had less chest pain. Another study found XC001 to be safe, with no serious side effects. This trial will include a treatment group receiving XC001 and a placebo group receiving A195/placebo. XC001 helps the heart grow new blood vessels, improving blood flow and reducing symptoms. Early results suggest that XC001 might alter the disease's course by reducing heart strain and discomfort.13678
Are You a Good Fit for This Trial?
This trial is for patients with Coronary Artery Disease (CAD) who are scheduled for a bypass surgery (CABG) but have heart areas that won't get enough blood flow due to technical challenges. Participants should show significant ischemia in stress imaging and not be candidates for complete revascularization.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive XC001 or placebo injections during the final stages of the CABG procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- XC001
Find a Clinic Near You
Who Is Running the Clinical Trial?
XyloCor Therapeutics, Inc.
Lead Sponsor