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| Current Trials |
The Heart Cells Foundation is currently funding three different clinical trials at The London Chest Hospital (part of Barts and The London 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. 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, |
People who have survived heart attacks often develop heart failure over time, despite the best medical treatment to delay or prevent its onset. It is estimated that there are currently over 800,000 people in the UK suffering from heart failure. The REGENERATE-IHD trial is funded by the Heart Cells Foundation and started in October 2005. This trial will involve approximately 150 patients whose hearts are failing because of long-standing coronary heart disease or previous heart attack(s). The trial involves testing three different stem cell therapy techniques and therefore has 3 separate arms. Each of these arms treats 1/2 the patients with there own stem cells and 1/2 with a placebo or 'sham' procedure to remove any psychological effect from the results: |
30 patients will have stem cells extracted from bone marrow in their hip and injected into their coronary (heart) arteries. 30 patients will have stem cells extracted from bone marrow in their hip and injected into their coronary (heart) arteries. 30 patients will have stem cells extracted from bone marrow in their hip and injected directly into their heart muscle in a minimally invasive operation. 30 patients will receive injections of a growth factor drug (G-CSF) to stimulate the production of stem cells in the bone marrow and cause them to overspill from the marrow into the circulating blood without the need for any operation. All of the patients are followed up with heart scans to assess the pumping function of the heart muscle to see if the treatment has caused any change. The initial pilot study including 58 patients has concluded and the results are pending publication in the scientific literature. Recruitment is still ongoing for the remainder of the trial, which requires a total of 90 patients, 49 of which have already been recruited. |
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, |
A heart attack results from a sudden complete blockage of blood in a coronary artery. If left untreated, this rapidly results in permanent damage to the area of the heart supplied by the artery. Patients who are treated at Barts and The London Heart Attack Centre are given an emergency angioplasty (a procedure that uses a balloon to unblock the artery through a minimally-invasive technique). This has significantly increased the patient's chance of survival compared with the more traditionally used clot-busting therapy. Even with rapid restoration of blood flow using emergency angioplasty, it is inevitable that the heart would sustain a degree of damage. |
The aim of the REGENERATE-AMI trial is to determine if stem cells taken from the patient's own bone marrow and injected into the newly re-opened artery within hours of the heart attack will help the heart repair itself. It is hoped that this will result in improved heart function, patients' quality of life and prevent or delay the onset of heart failure. Consultant cardiologist, Professor Anthony Mathur said: "The REGENERATE-AMI trial started in March 2008 and we have now recruited more than 40 out of the 100 patients needed for this study and again have initial agreement with centers in Switzerland, Austria and Denmark to also join in this trial. The study is being done in conjunction with the University College Hospital and the Royal Free Hospital in London should be joining in the next few months." The research is supported by the UK Stem Cell Foundation, the Heart Cells Foundation and has funding from the London Development Agency. |
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, |
The REGENERATE-DCM trial involves patients with dilated cardiomyopathy (DCM). DCM means that the left ventricle, which is the main pumping chamber of the heart, becomes dilated (stretched). When this happens, the heart muscle becomes weak and is unable to pump blood efficiently around the body. In most cases, the exact reason for dilated cardiomyopathy is not known and the condition is often called 'idiopathic dilated cardiomyopathy'. |
The REGENERATE-DCM trial is funded by the Heart Cells Foundation and started in July 2010. We will recruit 60 patients into the trial. The trial will involve testing two different stem cell therapy techniques and therefore will have 2 separate arms. Both of these arms will treat 1/2 the patients with as described and 1/2 with a placebo or 'sham' procedure to remove any psychological effect from the results: 1. 30 patients will receive injections of a growth factor drug (G-CSF) to stimulate the production of stem cells in the bone marrow and cause them to overspill from the marrow into the circulating blood without the need for any operation. 2. 30 patients will have a 5 day course of a growth factor drug (G-CSF) and then stem cells extracted from bone marrow in their hip and injected into their major coronary arteries in a minimally invasive operation. All of the patients will be followed up with heart scans to assess the pumping function of the heart muscle to see if the treatment has caused any change. |
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. |
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