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First patient recruited for regenerative human heart valve study

14 September 2017  

The Trust has recruited its first patient on an exciting trial to replace faulty aortic valves with donated human heart valves that have been stripped of accompanying donor material.

Heart valve disease occurs when one or more heart valves become damaged or diseased and affect the flow of blood through the heart. Heart valve problems can be present at birth or be caused by changes that develop later in life.

There are two main types of valve replacement options currently available for people with heart valve problems; mechanical and tissue. Mechanical valves are made from materials such as metal or plastic and tissue valves are obtained from human or animal donors.

For this trial - known as the Aortic Valve Replacement using Individualised Regenerative Allografts (ARISE) trial - a specific valve, the aortic valve, is replaced with a human donor valve (homograft) that has been decellularised.

Decellularised homografts are human donor heart valves which have been treated and stripped completely of all cells, leaving behind a “scaffold” of the original tissue. When placed in a patient, it is thought that the tissue will then become populated with the recipient’s own cells.

The aim of the study is to determine whether the use of these treated valves will slow down the rate of wear and tear that occurs in patients with aortic valve problems.

Previously a similar trial, the European Clinical Study for the Application of Regenerative Heart Valves (ESPOIR), involved the replacement of the pulmonary valve with decellularised pulmonary valves in children. They were followed up seven years after the procedure and the results found that there was significantly less evidence of degeneration compared to untreated pulmonary valves. 

The ARISE consortium includes five other leading heart centres across Europe. Professor John Pepper, consultant cardiac surgeon, who is leading the study said: “The standard procedure for valve replacement involves the implantation of mechanical valves or biological heart valves of animal origin. Both options have significant drawbacks. Mechanical valves require a lifelong regimen of blood thinners and animal tissue valves degenerate after about eight to ten years, requiring additional surgery, which leads to an increased risk for patients with each reoperation. 

"At this Trust we have 40 years of experience with the implantation of human heart valves. This process of removing the cells and allowing the patient’s own cells to populate the graft is likely to significantly increase the durability of this biological valve.”

Peter Spicer, aged 74, who became the first patient in the UK to take part in the study hopes that the research can help alleviate his symptoms and that his contribution to research in the area will help people in the future.

Peter said: “I know it sounds clichéd but I really wanted to be able to contribute to the research that is being done. It's great to be the first patient to have this kind of operation and the staff have all been brilliant."

If you would like to find out more about this study please visit the trial website or email us.


This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 643597.

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