July 31, 1998. Copyright, 1998, Graphic News. All rights reserved.

PIG TO HUMAN TRANSPLANTS ÔMONTHS AWAYÕ
By Oliver Burkeman, Science Editor

LONDON, July 31, Graphic News: ANIMAL organs could be transplanted into humans in Britain within months after the Government yesterday [Thursday] established the first formal regulations governing the technology.

Health Secretary Frank Dobson announced a raft of measures to regulate the procedure, known as ÔxenotransplantationÕ, including a working group to study the risk of transmission of diseases from animals to humans. Under the new rules, the UK Xenotransplantation Interim Regulatory Authority (UKXIRA), established in early 1997, will receive and scrutinise applications from those wishing to carry out the transplants, though Ministers will retain the final say on a case-by-case basis.

One company is already believed to be preparing an application to the revamped body. Cambridge-based Imutran claims to have overcome the main barrier to xenotransplantation: the human immune systemÕs aggressive rejection of organs which it recognises as non-human. So-called Ôhyperacute rejectionÕ means that human recipients of animal organs have usually died a few months after the operation.

Imutran says it has bred pigs whose organs will ÔtrickÕ the human body into accepting them Ð because the sowsÕ eggs from which they are descended were injected with human DNA. The technique holds out the hope of narrowing the widening gap between organ supply and demand which has led to a current waiting list of 5,000 for kidneys in the UK alone.

Hearts from the Imutran pigs were successfully transplanted into monkeys as long ago as 1995, and now the company wants to use pig livers in humans Ð although the livers themselves would remain outside the body, like a dialysis machine. But fears persist that potentially lethal viruses could jump from animals to human transplant patients.

ÔThe concern is not just that the individual recipient might become infected,Õ Professor Robert Weiss, of the Institute of Cancer Research, told BBC news. ÔSuppose it then spreads to that personÕs contacts and sets off an epidemic Ð thatÕs a remote possibility, but we want to be wise before the event.Õ

Mr Dobson stressed the safety issue yesterday. ÔTrials in xenotransplantation involving humans will only be allowed to take place if and when we are fully satisfied that the risks associated with such procedures are acceptable taking account of all the available evidence at the time,Õ he said. Though UKXIRA would continue to regulate the field on a non-statutory basis, he warned that Ministers Ôstand ready to take action at short notice to prevent undesirable activities if that becomes necessaryÕ.

Imutran welcomed Mr DobsonÕs announcement, promising in a statement to take a Ôcautious stepwise approachÕ to the technique. ÔThe company will only submit an application to proceed to clinical trials when we are confident that the scientific and safety issues have been addressed,Õ the statement said. Spokesperson Dr Corinne Savill predicted that it would take months of tests before surgery could begin.
/ENDS

Sources: Department of Health (press office: 0171 210 5221), Imutran (press office:
0181 332 2046)