Active not recruitingPHASE2INTERVENTIONAL

Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM

The DCM Support study is exploring a new way to treat dilated cardiomyopathy (DCM), a condition where the heart muscle becomes stretched and weakened, making it harder to pump blood. This can lead to heart failure symptoms like breathlessness and tiredness. Researchers are testing if using a patient's own stem cells, taken from their bone marrow, can help their heart work better and relieve these symptoms. During the procedure, these stem cells are put back into the heart's blood vessels, with a small temporary heart pump used to support the heart. The study aims to see if this treatment can improve how well the heart pumps blood.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Barts & The London NHS Trust

Enrolment target

Start

24 Dec 2018

Estimated completion

31 Mar 2030

Dilated Cardiomyopathy

What is this study about?

The DCM Support study is for people in the UK who have dilated cardiomyopathy (DCM) and are experiencing ongoing symptoms of heart failure. DCM is a serious heart condition where the heart's main pumping chamber stretches and thins. This makes it harder for your heart to pump enough blood around your body, leading to symptoms like shortness of breath and extreme tiredness, even with current treatments. This study is taking place at St Bartholomew's Hospital in London.

This study is investigating if using your body's own special cells, called stem cells, can help to strengthen your heart and improve these symptoms. Stem cells are like 'master cells' that can develop into different types of cells, and scientists are hopeful they might help repair damaged heart tissue. In this study, we are looking at stem cells collected from your bone marrow.

The main aim is to see if this treatment can make your heart pump blood more effectively. Researchers will be especially looking at changes in how well your heart pumps at the 3-month mark after the procedure. This is a "Phase 2" study, which means it's still in the earlier stages of testing to see how well the treatment works and if it's safe.

Key takeaways

Exploring if a patient's own stem cells can help improve heart function in DCM.
Aims to reduce heart failure symptoms like breathlessness and tiredness.
Involves collecting stem cells from bone marrow and infusing them into the heart.
A small, temporary heart pump is used during the stem cell infusion.
Takes place at St Bartholomew's Hospital in London, UK.
Follow-up appointments last for about one year.

Who may be eligible?

This study is looking for people aged 18 to 85 who have been diagnosed with dilated cardiomyopathy (DCM). You should be experiencing ongoing heart failure symptoms that haven't fully improved with standard treatments and devices. Your heart's pumping ability (called ejection fraction) should be 35% or less. Essentially, this study is for those who have limited other treatment choices available.

There are also some reasons why you might not be able to join. For example, if you have certain other heart conditions like problems with your heart valves or heart defects you were born with. You also wouldn't be able to join if you have certain serious infections, some long-term illnesses, or if you've had cancer recently that isn't in remission. People who have had previous heart surgery or have conditions that make the procedure unsafe, like blood clotting issues, would also not be eligible.

It's important to have a stable home address and be able to attend follow-up appointments. If you're a woman who could become pregnant, further discussions would be needed. Your doctor can help you understand if this study might be right for you.

Quick self-check

Have you been diagnosed with dilated cardiomyopathy (DCM)?
Are you experiencing ongoing heart failure symptoms like breathlessness or tiredness?
Have you tried standard treatments and devices without full improvement?
Is your heart's pumping ability (ejection fraction) 35% or less?
Are you between 18 and 85 years old?
Do you have limited other treatment options available to you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the first step involves a series of five daily injections under your skin. These injections contain a medication to help release stem cells from your bone marrow. Then, you'll have a procedure where doctors collect stem cells from your hip bone using a needle, under a local anaesthetic to numb the area.

Once your stem cells are collected and prepared, you'll have another procedure. During this, the stem cells will be carefully put into the arteries that supply blood to your heart. A small, temporary heart pump will be used to help support your heart during this procedure. Both of these procedures involve local anaesthetic.

After the procedure, you'll have follow-up check-ups. This includes a phone call about one month later, and then visits to the clinic at three months and again at twelve months to see how you're doing and how your heart function has changed. The total duration of active follow-up for this study would be about one year.

Potential risks and benefits

Participating in this study might offer a potential benefit of improved heart function and reduced heart failure symptoms, as researchers are hoping the stem cells could help repair your heart. However, it's important to remember this is a research study, and there's no guarantee the treatment will work for everyone, or at all. Potential risks linked to the procedures include discomfort or bruising where the bone marrow is collected, and risks associated with putting the stem cells into your heart such as bleeding or infection, similar to other heart procedures. There are also risks linked to using the temporary heart pump. You will be fully informed about all potential risks before deciding to take part, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

St Bartholomew's Hospital
London, United Kingdom

Common questions

What is dilated cardiomyopathy (DCM)?

DCM is a condition where your heart muscle becomes stretched and thin, making it harder for your heart to pump blood effectively, which can lead to tiredness and breathlessness.

What are stem cells?

Stem cells are special cells in your body that can grow into different types of cells. Researchers hope they might help repair damaged heart tissue.

Will I have surgery?

The procedures involve taking stem cells from your hip bone and then putting them into your heart's blood vessels. Both are done using local anaesthetic, so you'd be awake but the area would be numb. It's not major open-heart surgery.

Where does the study take place?

This study is taking place at St Bartholomew's Hospital in London, United Kingdom.

How long will I be involved in the study?

After the main procedures, you'll have follow-up appointments for about 12 months.