RecruitingPHASE2INTERVENTIONAL

Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

This research, called REGENERATE-COBRA, is testing a new way to treat severe, ongoing chest pain (refractory angina) that hasn't improved with other treatments. It involves taking stem cells from a patient's own bone marrow and putting them into the heart's arteries. The study wants to find out if this can reduce their chest pain and make their life better. Some patients will get the stem cell treatment, while others will have a 'sham' procedure that looks similar but doesn't involve stem cells. This helps researchers compare the effects accurately. All participants will be checked regularly for 6 to 12 months to see how they are doing.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Barts & The London NHS Trust

Enrolment target

110

Start

01 Mar 2024

Estimated completion

31 Aug 2026

Refractory Angina Pectoris Refractory Angina

What is this study about?

Many patients suffer from long-lasting chest pain, known as angina, even after trying various medications and procedures. When this pain continues despite all standard treatments, it's called "refractory angina." This can significantly affect daily life and overall well-being. The REGENERATE-COBRA study is exploring a new approach for these patients.

The study is investigating whether using special cells called stem cells, taken from a patient's own bone marrow, can help. The idea is that these stem cells might help repair or improve the blood flow to the heart, potentially leading to less chest pain and a better quality of life. This is a "Phase 2" study, meaning it's still in the early stages of testing this treatment's safety and how well it works.

To ensure fair results, patients will be randomly put into one of two groups, like flipping a coin for a 50/50 chance. One group will receive the actual stem cell treatment, while the other will have a "sham" procedure. No one, not even the patients, will know which group they are in. This is a common and important research method to make sure the results are reliable and not influenced by expectations.

Key takeaways

Targets long-lasting chest pain (refractory angina) not helped by other treatments.
Tests if patient's own stem cells can improve symptoms and quality of life.
Participants are randomly assigned to either stem cell treatment or a 'sham' procedure.
No one knows which treatment they receive until after the study is complete.
Involves minor procedures under local anaesthetic and 12 months of follow-up.
Study takes place at St Bartholomew's Hospital in London.

Who may be eligible?

This study is looking for adults over 18 years old who have severe, ongoing chest pain (angina) that has not responded to all other available treatments for at least 90 days. You must have already tried the highest safe doses of at least two different types of angina medications, and these treatments need to have been stable for at least two months.

Crucially, you would be considered if other heart procedures, like bypass surgery or stents, are not an option for you, or if they carry a very high risk. You also need to show signs that your heart muscle still has areas that could benefit from improved blood flow, and your angina must be limiting your physical activity. Your heart's pumping ability (ejection fraction) should be at least 30%, measured within the last year.

However, you cannot join if you've recently had a heart attack (within 30 days) or if you've had a successful heart bypass or stent procedure within the last six months. You also need to be willing to give your consent and attend all the required follow-up appointments.

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 over 18 years old?
Do you have severe, ongoing chest pain (angina) that hasn't responded to full treatment for at least three months?
Are other heart intervention options (like stents or bypass surgery) not suitable or too risky for you?
Have you been on stable angina medication for at least two months?
Is your angina limiting your daily physical activities?
Have you not had a heart attack in the last 30 days or successful heart surgery/stent in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to either the treatment group or the 'sham' group, and you won't know which one. Both groups will have careful procedures and follow-up. For both groups, you'll have an initial assessment and then two main procedures that involve local anaesthetic (meaning you'll be awake but the area will be numb).

If you're in the treatment group, a small amount of bone marrow will be collected from your hip. Later, these processed stem cells will be put into the arteries that supply your heart using a thin tube inserted through your wrist or groin. If you're in the 'sham' group, you'll have a very small cut (3mm) in your hip that looks like the bone marrow collection, and a thin tube will be inserted into your wrist or groin, but no cells will be infused. Both procedures will involve wearing a blindfold and headphones to help maintain the 'blinded' nature of the study.

After these procedures, everyone will have follow-up appointments: a phone call at 1 month and 12 months, and a clinic visit at 6 months. The total duration of your participation will be 12 months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in your angina symptoms and an improvement in your quality of life, especially if you receive the active stem cell treatment. However, as with any medical procedure, there are potential risks, though the procedures use local anaesthetic, meaning you're awake, and involve established methods for accessing blood vessels and bone marrow. These risks will be fully explained before you agree to take part. It's important to remember that 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.

St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is refractory angina?

It's long-lasting chest pain that hasn't gotten better even after trying various medications and procedures.

What are stem cells?

They are special cells from your body that have the ability to develop into different cell types and may help repair damaged tissues.

Will I know if I'm getting the real treatment?

No, you won't. This is a 'blinded' study to make sure the results are as fair and accurate as possible.

Where does the study take place?

The study is taking place at St Bartholomew's Hospital in London, UK.

How long will I be involved in the study?

Your involvement in the study will last for 12 months, including follow-up phone calls and a clinic visit.

How to find out more

Stem Cell Research Team

bhnt.stemcells@nhs.net 0203 765 8704 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.