Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I Randomised Double-Blind Placebo Controlled Safety Study of Intramyocardial Injection of CLXR-001 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

This research study is for people who are planning to have a type of heart surgery called coronary artery bypass graft (CABG). This surgery helps improve blood flow to the heart. During this surgery, doctors will also inject a new, experimental medicine called CLXR-001 directly into the heart muscle. The main goal of this study is to find out if this new treatment is safe for people. Because it's a very early stage of research, we're not yet looking at whether it makes people better, but simply checking for safety and if there are any unwanted effects. Some people will receive the new medicine, while others will get a 'dummy' treatment, so we can compare them fairly. All participants will have had damage to their heart muscle due to blocked arteries, a condition called ischaemic cardiomyopathy.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Cell Therapy Limited

Enrolment target

Start

03 Dec 2024

Ischaemic cardiomyopathy

What is this study about?

This research study is open to people who are going to have an important heart operation known as coronary artery bypass graft, or CABG surgery. This surgery is often done when the arteries that supply blood to your heart become narrowed or blocked, which can lead to a condition called ischaemic cardiomyopathy (where the heart muscle is weakened due to lack of blood flow). During this surgery, the doctors will also give a new, experimental treatment called CLXR-001 by injecting it directly into your heart muscle.

The main purpose of this study is to check if this new treatment, CLXR-001, is safe for people. Since this is the very first time this treatment is being given to humans, the researchers are very carefully watching for any side effects or problems. It's a bit like testing a new car for the first time – you first want to make sure the brakes work and it's safe to drive, before you worry about how fast it can go. So, for now, we're not focused on whether the treatment improves your heart condition, but purely on its safety.

To make sure the results are fair and accurate, this study is 'randomised and double-blind'. This means that some people will receive the actual CLXR-001 treatment, while others will receive a 'dummy' treatment (a placebo) that looks exactly the same but contains no active medicine. Neither you nor your doctor will know which one you receive until after the study is over. This helps to ensure that researchers can properly compare the two groups and see if any effects are truly due to the new treatment.

Key takeaways

The study is for adults having heart bypass surgery.
It's testing a new medicine (CLXR-001) injected into the heart.
The main goal is to check if the new medicine is safe.
Some people will get the active medicine, others a dummy treatment.
You won't know which one you receive until after the study.

Who may be eligible?

To be considered for this study, you must be an adult, 18 years old or older, and planning to have coronary artery bypass graft (CABG) surgery. Both men and women are welcome to take part.

You should also have a specific heart condition called ischaemic cardiomyopathy. This means your heart muscle has been weakened or damaged because of problems with the blood supply to your heart, usually due to narrowed or blocked arteries.

There will be other detailed health checks to make sure the study is safe for you and that your participation will help the researchers get clear results. Your doctor will be able to tell you if you meet all the specific requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for heart bypass (CABG) surgery?
Do you have a heart condition called ischaemic cardiomyopathy (weakened heart muscle due to blocked arteries)?
Are you willing to have an experimental treatment injected into your heart during surgery?
Are you able to attend follow-up appointments after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement will centre around your planned heart bypass surgery. Before your surgery, you will have several health checks and tests to make sure you are suitable for the study. During your CABG surgery, you will receive the study treatment (either the new medicine or the dummy treatment) as an injection into your heart muscle. After your surgery, you will have regular follow-up appointments and tests. These will involve clinic visits, blood tests, and heart scans to closely monitor your health and check for any changes or side effects. The total length of your participation will include regular checks for a period of time after your surgery, which will be explained in full detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be contributing to important medical knowledge that might help others in the future, and you will receive very close medical attention during the study. However, because this is an early study, the main aim is to check safety and we don't expect it to directly improve your heart condition at this stage. There's always a risk of side effects from any new medicine or procedure, and these will be carefully monitored. You will be told about all known or possible risks before you agree to join. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary

Common questions

What is CABG surgery?

CABG (Coronary Artery Bypass Graft) surgery is an operation to improve blood flow to the heart when the arteries supplying it are blocked or narrowed.

What does 'Phase I' mean?

Phase I means this is one of the very first times this new treatment is being given to people. The main goal is to check if it's safe.

What is 'ischaemic cardiomyopathy'?

It's a heart condition where your heart muscle is weakened because it hasn't been getting enough blood due to blocked arteries.

Will I know if I get the real medicine or the dummy treatment?

No, neither you nor your doctor will know whether you are given the active medicine or the dummy treatment until after the study is complete. This helps keep the results fair.

Will this new treatment cure my heart condition?

This early study is mainly focused on safety, not on whether the treatment can cure your condition. That would be looked at in later studies if this one proves safe.