Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Danish, double-blind, randomized placebo-controlled clinical trial evaluating allogeneic adipose tissue derived mesenchymal stromal cell therapy in patients with recently diagnosed non-ischemic heart failure with reduced ejection fraction.

This study, happening in Denmark, is testing a new cell treatment called C2C_ASC110 for a condition called non-ischemic heart failure. This is a type of heart failure where the heart muscle doesn't squeeze as strongly as it should, but it's not caused by blocked arteries. Patients will either receive the new cell treatment or a dummy treatment (placebo) containing only ingredients used to keep the cells healthy. Nobody, neither the patients nor their doctors, will know who is getting which treatment. The main goal is to see if the cell treatment improves how well the heart pumps blood six months after the last treatment, compared to the dummy treatment. This is a Phase II trial, meaning it's an early-stage study to learn more about the treatment's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cell2Cure ApS

Enrolment target

Start

08 Dec 2025

Non-ischemic heart failure with reduced ejection fraction

What is this study about?

This study is designed to explore a new treatment for a specific type of heart condition known as non-ischemic heart failure with reduced ejection fraction. In simple terms, this means your heart muscle isn't pumping blood as effectively as it should, and this isn't due to problems like clogged arteries. The treatment being tested is called C2C_ASC110, which uses special cells derived from fat tissue. The aim is to see if these cells can help improve heart function.

To make sure the results are fair and accurate, the study uses a 'double-blind, randomised, placebo-controlled' approach. This means that participants will be randomly assigned to either receive the active cell treatment or a 'placebo'. A placebo is a dummy treatment; in this case, it's a solution called CryoStor® CS10, which is used to store the active cells but does not contain the active cells themselves. Importantly, neither you nor your doctors will know whether you're receiving the active treatment or the placebo. This helps prevent any bias in the results.

The main thing researchers want to find out is whether the new cell treatment improves how well your heart pumps blood, specifically measuring something called your 'ejection fraction' (LVEF), six months after you've had the treatment. They will also be looking at other important aspects like how well you can exercise (using a 6-minute walk test), your quality of life, and other measures of your heart health over a longer period, up to 12 months after treatment. They will also be carefully monitoring for any unexpected side effects.

Key takeaways

This study is testing a new cell therapy for specific heart failure.
It's 'double-blind', meaning neither you nor your doctor will know if you're getting the active treatment or a dummy.
The main goal is to see if heart pumping ability improves after 6 months.
You would be monitored for 12 months if you take part.
Participation is for adults aged 18 and over with the specific type of heart failure.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women are welcome to participate. The most important requirement is that you have recently been diagnosed with a specific type of heart failure where your heart isn't pumping blood strongly enough, and this isn't caused by blocked arteries or similar issues.

There might be other health conditions or medications that would mean you can't join the study, as these could affect the results or your safety. The study team will review your medical history carefully to make sure it's safe and appropriate for you to take part.

If you're interested, the research team will explain all the specific criteria in detail. This ensures that the study includes people who are a good fit for the research questions being asked.

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?
Have you recently been diagnosed with heart failure?
Is your heart failure NOT caused by blocked arteries?
Does your heart have a reduced pumping ability (reduced ejection fraction)?
Are you willing to attend follow-up appointments for up to 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first go through a screening process to confirm you meet all the requirements. Once confirmed, you would receive either the C2C_ASC110 cell therapy or the placebo, given as an infusion. Neither you nor your study doctor will know which treatment you are receiving until after the study is complete. You would then have several follow-up appointments over a period of 12 months. These appointments will involve various assessments, including checks on your heart function (like echocardiograms to look at how your heart is pumping), physical tests like a 6-minute walk, and questionnaires about your quality of life. The research team will also monitor you closely for any side effects. The total duration of your active participation, including follow-up, would be for 12 months from your last treatment.

Potential risks and benefits

Participating in a clinical trial offers the chance to gain access to a new experimental treatment before it's widely available. While the treatment being tested might improve your heart function, there's no guarantee it will work for everyone, and you might receive the placebo. There's also a possibility of side effects from any treatment or procedure, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without 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
Denmark

Common questions

What is 'non-ischemic heart failure with reduced ejection fraction'?

It's a type of heart failure where your heart muscle doesn't pump blood as strongly as it should, and it's not due to blocked arteries. 'Ejection fraction' describes how much blood your heart pumps out with each beat.

What is a 'placebo' in this study?

The placebo in this study is a solution called CryoStor® CS10. It's used to store the active cells but doesn't contain the actual cell therapy. It's a dummy treatment that helps researchers compare the effects of the active treatment fairly.

Why don't I know if I'm getting the real treatment or the placebo?

This is called 'double-blind'. It's important so that neither you nor the doctors know who is getting what. This helps prevent anyone's expectations from influencing the results, making the study more scientifically sound.

What is 'ejection fraction (LVEF)'?

Ejection fraction (LVEF) is a measurement that shows how much blood your heart's main pumping chamber (left ventricle) pumps out with each beat. A higher number usually means your heart is pumping more effectively.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It means researchers are exploring if a new treatment is effective and safe for a specific condition, after initial safety tests have been done.