Clinical Trials
Ground-breaking heart stem cell trial (REGENERATE) now underway
By Barts and The London NHS Trust
Oct 13, 2005, 15:25

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."


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