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

FIRST-IN-HUMAN OPEN-LABEL MULTICENTRE CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF EPICARDIAL IMPLANTATION OF COLLAGEN MEMBRANES WITH ALLOGENEIC ADIPOSE-DERIVED STEM CELLS IN PATIENTS WITH ISCHAEMIC LEFT VENTRICULAR DYSFUNCTION SCHEDULED TO UNDERGO CORONARY REVASCULARISATION SURGERY

This is an early study, called a Phase 1 trial, designed to test a new treatment for people with serious heart failure caused by blocked arteries. These patients are already scheduled to have heart bypass surgery. The new treatment involves placing a special patch, containing stem cells from donated fat, directly onto the surface of the heart. Researchers want to find out if this treatment is safe for humans and if it can help improve how well the heart pumps blood. Because it's a first-in-human study, it focuses heavily on safety while also looking for early signs of effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Viscofan Espana S.L.U.

Enrolment target

Start

05 Nov 2024

ventricular failure caused by ischemic heart disease

What is this study about?

This study is looking into a new way to help people with a severe form of heart failure. This type of heart failure happens when the heart muscle is damaged because it doesn't get enough blood, often due to blocked arteries. If your doctor tells you that you have 'ventricular failure caused by ischaemic heart disease', this study might be relevant.

The new treatment involves a special patch, or 'membrane', which is placed on the outside of the heart. This patch contains special cells called 'stem cells' that come from donated fat. The idea is that these stem cells might help to repair or improve the function of the damaged heart muscle. The treatment is given at the same time as heart bypass surgery, an operation some people already need to improve blood flow to their heart.

This is a 'first-in-human' study, which means it's one of the first times this new treatment is being tested in people. The main goal is to check if it's safe and doesn't cause serious problems. Researchers will also be looking to see if there are any early signs that it helps the heart pump blood more effectively. Because it's an early study, only a small number of people will take part.

Key takeaways

This is an early safety study for a new heart failure treatment.
It's for people with severe heart failure already having bypass surgery.
A special patch with stem cells is placed on the heart.
It aims to see if the treatment is safe and might help the heart pump.
Participation involves close monitoring before and after surgery.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. Both men and women can take part.

Crucially, you must have severe heart failure that is caused by problems with blood flow to your heart, and you must already be scheduled to have heart bypass surgery. The study treatment would be given during that planned operation.

There might be other health conditions or medications that would prevent you from joining, as the researchers need to make sure the study is as safe as possible for everyone involved.

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?
Do you have severe heart failure caused by blockages in your heart's blood supply?
Are you already scheduled for heart bypass surgery?
Are you comfortable with receiving an experimental treatment during your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment (a special patch with stem cells) during your planned heart bypass surgery. The researchers would then closely monitor your health before, during, and after your surgery. This would involve regular check-ups, possibly blood tests, heart scans, and other assessments to see how your heart is recovering and if the treatment is having any effect. The study would involve a number of follow-up visits over a period of time to track your progress. The full duration of your involvement, including all follow-ups, would be explained to you in detail.

Potential risks and benefits

As this is an early-stage study, the main potential benefit is helping researchers determine if this new treatment is safe and could eventually lead to an improved treatment for heart failure. You might also find personal benefit from the close medical monitoring you would receive. However, there are potential risks, as with any new medical treatment or surgery. These could include side effects related to the stem cell patch or complications from the surgery itself. The study team will explain all known potential risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Poland

Common questions

What are stem cells?

Stem cells are special cells in your body that can develop into different types of cells and help repair tissues. In this study, they come from donated fat.

What does 'first-in-human' mean?

It means this is one of the very first times this new treatment is being tested in people, so the main goal is to check for safety.

Will I know if I'm getting the actual treatment or a dummy treatment?

This study is 'open-label', which means both you and your doctors will know if you are receiving the active treatment.

What is heart bypass surgery?

It's an operation to improve blood flow to the heart by creating new routes around blocked or narrowed arteries.

How long will I be involved in the study?

The full duration, including follow-up visits, will be explained by the study team, but it will involve multiple check-ups over a period of time.