Clinical Trials

An exciting series of new research studies are being conducted at Barts Health NHS Trust to see if injecting a person’s own stem cells into their damaged heart can improve the symptoms and heart function of patients with heart failure.

Current Trials

The Heart Cells Foundation is currently funding three different clinical trials at The London Chest Hospital (part of NHS Trust):

REGENERATE-IHD trial – Adult stem cells for patients with chronic heart failure caused by coronary heart disease.

REGENERATE-AMI trial – Adult stem cells for patients immediately after being treated for an acute heart attack.  Jointly funded with the UK Stem Cell Foundation.

REGENERATE-DCM trial – Adult stem cells for patients with heart failure caused by dilated cardiomyopathy.

REGENERATE-IHD

“This is one of the biggest and most comprehensive trials of its kind in the world. Our studies will tell us if adult stem cells in bone marrow can repair damaged hearts and if so how these cells should be administered to patients. There is growing evidence to suggest that stem cells may benefit people with serious heart conditions, such as heart failure or those who have had heart attacks.”

Anthony Mathur,
Professor of Cardiology and principal investigator on the trial
Regenerate-IHD

 

The REGENERATE-IHD Study involved 90 patients with heart failure caused by
ischaemic heart disease (IHD) or a previous heart attack. Patients were randomised
into three groups. The first group received injections of G-CSF, a growth factor that
stimulates bone marrow, once a day for five consecutive days. Those in the second and third group received these injections and underwent a procedure to have stem cells extracted from bone marrow in their hip. These cells were ‘purified’ in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Within the second group, half of patients had their stem cells injected into their major coronary arteries via a catheter in a minimally invasive operation while the other half had their serum injected directly into their major coronary arteries. Within the third group, half had their stem cells injected directly into their heart muscle while the other half had their serum injected directly into their heart muscle.

Initial results (still awaiting publication) show that patients who received cell therapy experienced an improvement in the pumping action of their hearts leading to an improvement in their symptoms.

There is a press release on a new study funded by the European Commission which has resulted from the REGENERATE-AMI study carried out above.  To view this press release please click here.

REGENERATE-AMI

“If we can use a person’s own stem cells to repair the damage caused by a heart attack, this will be a significant step forward in the treatment of heart disease. Because the stem cells are taken from the patients themselves, the ethical issues surrounding this procedure are substantially reduced compared to those that surround the use of embryonic cells. There is also less likelihood of rejection complications.”

Anthony Mathur,
Professor of Cardiology and principal investigator on the trial
Regenerate-AMI

The REGENERATE-AMI Study involves 100 patients with recent Acute myocardial
infarction (AMI) or heart attack. Patients have stem cells extracted from bone marrow
in their hip shortly after undergoing a primary or emergency angioplasty to clear the blockage that triggered their heart attack. These cells are purified in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Half of patients will have their stem cells injected directly into their major coronary arteries via a catheter while the other half will have their serum injected directly into their major coronary arteries.

 

REGENERATE-DCM

“We hope to be able to answer important questions regarding whether stem cell therapy can help patients with this debilitating condition of dilated cardiomyopathy.”

Anthony Mathur,
Professor of Cardiology and principal investigator on the trial
Regenerate-DCM

 

The REGENERATE-DCM Study involves 60 patients with heart failure caused by
idiopathic dilated cardiomyopathy (DCM). Patients are randomised into two groups.
The first group receive injections of G-CSF in their arm once a day for five
consecutive days. The second group receive these injections and undergo a procedure to have stem cells extracted from their bone marrow in their hip. These cells are ‘purified’ in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Within the second group, half will have their stem cells injected into their major coronary arteries via a catheter while the other half will have their serum injected directly into their major coronary arteries.

 

If you suffer from heart failure and would like to know more about the study, please click here.

If you are a healthcare professional and would like to know more about the study, please click here.

There are several videos from News and Documentary programs available for viewing, please click here.

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