sentinel skin flaps monitoring heart transplantation
Research type
Research Study
Full title
Vascularised sentinel skin flaps to monitor for rejection in heart transplantation
IRAS ID
277633
Contact name
Henk Giele
Contact email
Sponsor organisation
clinical trials research governance
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Transplanted organs such as lungs, hearts, kidneys and pancreases are subject to attack by the immune system causing rejection of the transplanted organ. Rejection is prevented by immunosuppression medication that interferes with the body’s immune system and hinders rejection. Despite these medications rejection still occurs. If rejection is not detected and treated early enough the transplanted organ scars and stops working. Detecting rejection is difficult as it does not have specific features. In heart transplants attempts are made to detect rejection by very frequent hospital visits for chest x-rays, blood tests and biopsies of the transplanted heart. These tests are performed very regularly or of the patient has symptoms of heart disease such as swelling. All these tests can show are if there is inflammation but there is no specific measure of rejection until the rejection is very severe.
We discovered when we were doing intestinal transplants which included skin transplants that the skin displayed a easily visible rash when rejection was occurring, and that this sign was present before the intestine transplant rejected. The skin was visible continuously, so we did not have to rely on intermittent biopsies or other tests, but only performed these when the skin indicated there was rejection. As a result of this we began a trial, transplanting a patch of skin with pancreas and kidney transplants. Our preliminary results show this transplanted skin also acts as a monitor for rejection in pancreas and kidney transplants.
We wish to repeat this study in heart transplants to see if a skin transplant can act as a rejection monitor for heart transplants so that we can avoid the regular tests and hospital visits, reduce the immune suppression drug levels, and avoid rejection injury to the transplanted heart.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0027
Date of REC Opinion
17 Apr 2020
REC opinion
Further Information Favourable Opinion