A Study of XC001 Gene Therapy with Bypass Surgery for Patients with Coronary Artery Disease and Weakened Heart Function at Risk for Incomplete Treatment

2 1 1

What is this study about?

This study involves people with coronary artery disease who have chest pain and weakened heart function. Coronary artery disease occurs when the blood vessels that supply the heart become narrowed or blocked, reducing blood flow to the heart muscle. The study focuses on patients who are scheduled to have bypass surgery, which is a procedure where surgeons create new routes for blood to flow around blocked arteries. However, in some cases, the surgery may not be able to restore blood flow to all areas of the heart that need it. The study will test a new treatment called XC001, which is a gene therapy designed to help improve blood flow to the heart. Gene therapy works by delivering genetic material into the body to help produce substances that can promote the growth of new blood vessels. During the surgery, patients will receive either XC001 or placebo injected directly into the heart muscle. The study will also use several other medications as part of the imaging procedures, including adenosine, regadenoson, and gadobutrol, which help doctors see how well blood is flowing through the heart.

The purpose of the study is to find out if XC001 can reduce the amount of heart muscle that does not receive enough blood after bypass surgery, and to assess whether it can improve how well the heart contracts and pumps blood. The study will use a special type of imaging called cardiovascular magnetic resonance imaging, which creates detailed pictures of the heart while it is under stress to show areas that are not getting enough blood flow. The study is designed to last 26 weeks, with an additional 26-week extension period for those who continue. Patients will be randomly assigned to receive either XC001 or placebo during their bypass surgery, and neither the patients nor the doctors will know which treatment is given until the study is completed.

After the bypass surgery, patients will undergo imaging tests at several time points to measure changes in blood flow to the heart and how well the heart is functioning. The first imaging will be done a few days after surgery to establish a starting point, and then additional imaging will be performed at 12 weeks and 26 weeks after surgery. For those who participate in the extension period, another imaging test will be done at 52 weeks. Throughout the study, doctors will monitor the safety of the treatment and track any side effects or complications that may occur. The study will compare the results between patients who received XC001 and those who received placebo to determine if the gene therapy provides any benefit in improving blood flow to areas of the heart that could not be fully treated by bypass surgery alone.

1 Baseline period and surgery preparation

Before the bypass surgery, imaging tests will be performed to assess the heart condition and identify areas with reduced blood flow.

The heart function will be measured, with particular attention to the heart’s pumping ability, which should be between 25% and 50%.

Images of the coronary arteries will be reviewed to determine which areas may not receive complete blood flow restoration through standard bypass surgery.

2 Bypass surgery and study treatment administration

The planned bypass surgery will be performed as a standalone procedure using a heart-lung machine.

During the surgery, either XC001 gene therapy or placebo will be administered directly into the heart muscle through intracardiac injection.

XC001 is an investigational gene therapy designed to promote new blood vessel growth in areas of the heart that may not receive adequate blood flow after bypass surgery.

The assignment to receive either XC001 or placebo will be random, and neither the patient nor the medical team will know which treatment was given during the study period.

3 Early post-surgery assessment

Between 4 to 6 days after surgery, a baseline imaging test using cardiovascular magnetic resonance imaging will be performed.

This imaging test uses magnetic fields to create detailed pictures of the heart and will serve as the starting point for measuring treatment effects.

A contrast agent called gadobutrol will be administered through injection to improve image quality.

Either adenosine administered through infusion or regadenoson administered through injection will be used to create stress conditions during the imaging, allowing assessment of blood flow to different areas of the heart.

4 Week 12 assessment

At 12 weeks after surgery, another cardiovascular magnetic resonance imaging test will be performed.

The same contrast agent gadobutrol and stress-inducing medication (adenosine or regadenoson) will be used.

This test will measure changes in heart muscle blood flow and function compared to the baseline assessment performed shortly after surgery.

The imaging will focus on areas of the heart that were treated during surgery and assess whether blood flow has improved.

5 Week 26 assessment

At 26 weeks after surgery, the same cardiovascular magnetic resonance imaging test will be repeated.

The test will again use gadobutrol for contrast and either adenosine or regadenoson for stress testing.

This assessment will measure continued changes in heart muscle blood flow and pumping function.

This marks the completion of the primary study period.

6 Extension period – Week 52 assessment

The study includes an additional 26-week extension period for continued monitoring.

At 52 weeks after surgery, a final cardiovascular magnetic resonance imaging test will be performed.

The same imaging protocol with gadobutrol and stress medication (adenosine or regadenoson) will be used.

This final assessment will evaluate long-term effects on heart muscle blood flow and function.

Throughout the entire study period, contraception must be used for 6 months following the surgery if applicable.

Who Can Join the Study?

You must be between 18 and 80 years old at the time of signing the consent form
You must have symptoms of multivessel coronary artery disease, which means multiple blockages in the blood vessels that supply your heart with oxygen
A team of heart doctors must have decided that placing stents is not suitable for you and that coronary artery bypass grafting (a surgery where blood vessels are used to bypass blocked arteries in your heart) is the best treatment option
You must need planned heart bypass surgery that is not combined with valve surgery and uses a heart-lung machine
You must be at high risk for incomplete revascularization, meaning the surgery may not be able to restore full blood flow to all areas of your heart
You must have chest pain or shortness of breath with activity that is moderate to severe in intensity
Your left ventricular ejection fraction (a measure of how well your heart pumps blood) must be between 25% and 50%, which indicates weakened heart function
You must have specific findings on heart imaging tests that show blockages likely cannot be completely fixed by surgery, such as widespread disease in small blood vessels, multiple blockages along the same artery, very small vessels unsuitable for grafting, arteries blocked by old stents, or areas of poor blood flow larger than what surgery can address
If you or your partner can have children, you must agree to use highly effective birth control methods for 6 months after the study procedure
Women who have gone through menopause or have had surgery to remove reproductive organs are exempt from birth control requirements
Female participants must agree not to donate eggs and male participants must agree not to donate sperm for 6 months after receiving the study treatment
You must be able to provide informed consent and complete all required tests and procedures in the study

Who Cannot Join the Study?

No exclusion criteria have been provided in the study information available.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Gottsegen National Cardiovascular Center	Budapest	Hungary
Semmelweis University	Budapest	Hungary
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany
University Of Pecs	Pecs	Hungary
University Of Szeged	Szeged	Hungary
Zala County Saint Raffael Hospital	Zalaegerszeg	Hungary
Leiden University Medical Center	Leiden	The Netherlands
Uniklinik Köln	Cologne	Germany
Cbhcljk Gjqzci Hsjrn Czgsqn	Berlin	Germany
Wzrurroxzjhfcqpwwbrs Scdchhy Mpecrjhyg	Warsaw	Poland
Eridurk Uwoekxiggsuc Mqvxuor Cfewydh Rtvrrdgto (ujadewj Mwv	Rotterdam	The Netherlands
Amsftyvlm Uwo	Amsterdam	The Netherlands
Kayberjck Sczskwp Skeeyshyvjhjzej il Johz Pwnkj Ik	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.09.2025
Hungary	Not recruiting	30.09.2025
Poland	Not recruiting	30.09.2025
The Netherlands	Not recruiting	30.09.2025

Trial locations

Investigated drugs:

XC001 is a gene therapy being tested in this study. It is given during heart bypass surgery to help improve blood flow to areas of the heart that cannot be fully treated by the bypass surgery alone. The therapy works by delivering genetic material to help the heart grow new blood vessels in areas where blood flow is reduced.

Placebo is an inactive substance that looks like the real treatment but contains no active therapy. It is used for comparison to see if XC001 actually works better than no gene therapy treatment.

Investigated diseases:

Coronary artery disease

Chronic Angina – Chronic angina is a type of chest pain or discomfort that occurs when the heart muscle does not receive enough oxygen-rich blood. This condition is typically caused by narrowing or blockage of the coronary arteries, which supply blood to the heart. The pain or discomfort usually occurs during physical activity or emotional stress and improves with rest. Chronic angina is a recurring condition that can persist over time and may indicate underlying heart disease. People with this condition often experience a squeezing, pressure, or burning sensation in the chest. The symptoms follow a predictable pattern and occur under similar circumstances each time.

Left Ventricular Dysfunction – Left ventricular dysfunction is a condition where the left ventricle, the heart’s main pumping chamber, does not work properly. This chamber is responsible for pumping oxygen-rich blood to the rest of the body. When it becomes weakened or damaged, it cannot pump blood effectively, leading to reduced blood flow throughout the body. The condition develops when the heart muscle is damaged by disease, such as coronary artery disease, which affects the blood vessels supplying the heart. As the dysfunction progresses, the heart struggles to meet the body’s demands for blood and oxygen. This can lead to symptoms such as fatigue, shortness of breath, and fluid buildup in various parts of the body.

Coronary Artery Disease – Coronary artery disease is a condition where the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased. This damage typically occurs due to the buildup of fatty deposits called plaques along the artery walls, a process known as atherosclerosis. As plaques accumulate, the arteries narrow, reducing blood flow to the heart muscle. Over time, this reduced blood flow can cause chest pain, shortness of breath, and other symptoms. The disease progresses gradually, often over many years, and may eventually lead to complete blockage of an artery. Risk factors include high cholesterol, high blood pressure, smoking, diabetes, and family history of heart disease.

Trial ID:

2025-521325-33-00

Protocol code:

XC001-1003

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A Study of XC001 Gene Therapy with Bypass Surgery for Patients with Coronary Artery Disease and Weakened Heart Function at Risk for Incomplete Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?