Ground-breaking heart stem cell trial (REGENERATE) now underway
Oct 13, 2005 - 3:25:00 PM, Reviewed by: Dr.
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"Stem cells are the body�s master cells. They are unique because unlike other cells they can turn into almost any other type of cell in the body. Our studies will determine if adult stem cells in bone marrow can repair damaged heart muscle. Heart disease is one of the UK�s biggest killers. It affects almost 2.7m people and claims 120,000 lives each year. If proven to work, these cells could revolutionise the way we treat heart disease and could transform the lives of millions of people not only in the UK but around the world."
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By Barts and The London NHS Trust ,
Doctors at Barts and The London NHS Trust have launched the UK�s first large-scale clinical trial designed to find out if a patient�s own stem cells can be used to treat heart disease.
The ground-breaking research, which is being funded by the Heart Cells Foundation charity, will involve 700 patients over the next four years.
The trial is made up of three randomised-controlled studies. The first study will involve 300 patients whose hearts are failing because of heart disease or a previous heart attack. The second study will involve 200 patients whose hearts are failing specifically because of dilated cardiomyopathy � a heart muscle disorder. The third study will involve 200 patients who have just had a heart attack.
Doctors are testing three different stem cell therapy techniques as part of the trial. Some patients will have stem cells extracted from bone marrow in their hip and injected into their major coronary arteries or directly into their heart in a minimally invasive operation. Others will receive injections of growth factor drugs to try to cause stem cells to spill out of their bone marrow and into their blood without the need for the operation.
Consultant Cardiologist Dr Anthony Mathur, who is leading the research, said: "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.
"Stem cells are the body�s master cells. They are unique because unlike other cells they can turn into almost any other type of cell in the body. Our studies will determine if adult stem cells in bone marrow can repair damaged heart muscle. Heart disease is one of the UK�s biggest killers. It affects almost 2.7m people and claims 120,000 lives each year. If proven to work, these cells could revolutionise the way we treat heart disease and could transform the lives of millions of people not only in the UK but around the world."
Ian Rosenberg, Founder of the Heart Cells Foundation, said: "Two years ago, I was given just a couple of months to live. I travelled to Germany where they have pioneered stem cell therapy for heart disease to have my own stem cells injected into my heart. Within a matter of months, I was able to do things I could only dream of doing before, such as walking up and down stairs or playing golf. Stem cell therapy has given me years I never thought I would have.
"I set up the Heart Cells Foundation so that others may benefit from this new and exciting science. We have launched an appeal to raise the �6m needed to fund this research at Barts and The London NHS Trust. We have already raised �1m, enabling this historic trial to get underway. I believe this trial will provide us with the clear evidence we need to ensure others can benefit from stem cell therapy."
- Barts and The London NHS Trust
The clinical trial is being funded by a charitable appeal. To donate, contact the Appeal Office on tel. 020 7601 8873 or go online at www.heartcellsfoundation.com
Case Studies:
Gerry Sherrick, aged 71, a retired taxi driver from Essex, has volunteered to take part in the clinical trial. He said: "I have had heart problems for the past 25 years. I have had two heart attacks and two triple bypass operations but my heart has become steadily weaker over the years. I now struggle to do many of the things I could do before. Mundane tasks like getting washed, eating and even lifting up a newspaper can leave me feeling completely exhausted. I have my good days but on others it can be a struggle just to get out of bed. I am delighted to be taking part in this clinical trial. I know that there are no guarantees but I hope that my involvement if it doesn�t benefit me will benefit others."
David Temperley, aged 61, a retired factory worker from Teesside, has volunteered to take part in the clinical trial. He said: "My heart has seen better days. I have had three heart attacks. My first heart attack was in 1990 and my most recent one was four years ago. I have been fitted with a defibrillator and a stent to try to ward off a fourth heart attack. My heart seems to have gone down hill in the last two years but there is nothing doctors can do to help me. My heart is too damaged to have bypass surgery and I�m too old to have a transplant. I heard about plans to carry out this clinical trial last year. I spoke to my GP about it. He referred me to a specialist in Middlesbrough who in turn referred me to the team at Barts and The London NHS Trust. I am delighted to be taking part."
Heart Stem Cell Trial
The REGENERATE (Heart Stem Cell) Trial at Barts and The London NHS Trust will run for four years and is made up of three randomised-controlled studies:
* The REGENERATE-IHD Study will involve 300 patients with heart failure caused by ischaemic heart disease (IHD) or a previous heart attack. Patients are randomised into three groups. The first group receive 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 receive these injections and undergo a procedure to have stem cells extracted from 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 of patients have their stem cells injected into their major coronary arteries via a catheter in a minimally invasive operation while the other half have their serum injected into their major coronary arteries. Within the third group, half will have their stem cells injected directly into their heart muscle while the other half will have their serum injected directly into their heart muscle.
* The REGENERATE-DCM Study will involve 200 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 into their major coronary arteries.
* The REGENERATE-AMI Study will involve 200 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 into their major coronary arteries.
Primary Angioplasty
Doctors at Barts and The London NHS Trust were among the first in the UK to offer primary or emergency angioplasties routinely to heart attack patients. Instead of going to A&E, appropriate patients are taken directly to The London Chest Hospital in Bethnal Green, part of the Trust, where they immediately undergo this procedure. A catheter is inserted into the patient�s body and fed up through their arteries until it reaches the blockage. A tiny balloon is fed up through the catheter and blown up when it reaches the blockage, re-opening the artery and clearing the blockage. A stent or tiny metal scaffold is then placed inside the artery to stop it from narrowing and becoming blocked again. The procedure is carried out under local anaesthetic so patients are usually awake throughout.
Barts and The London NHS Trust
Barts and The London NHS Trust is one of Britain�s top teaching hospital trusts. Over 500,000 people from the City, East London and further afield are treated at the Trust every year. The Trust is made up of three hospitals - Barts in the City, The Royal London in Whitechapel and The London Chest Hospital in Bethnal Green.
Heart Cells Foundation
The Heart Cells Foundation is a registered charity (No. 1101727). It was set up in January 2004 to raise money to fund research into stem cells for the treatment of heart disease. Its trustees are Ian Rosenberg, Jenifer Rosenberg, Dr Anthony Mathur (advisor), Dr Anthony Nathan, Sir Bernard Rix, Professor Martin Rothman, Stephen Sampson and Nicholas Woolf.
Individuals interested in taking part in the clinical trial can obtain further information by telephoning 020 7377 7333 or by emailing [email protected]
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