Time for an urgent review of Xenotransplantation

NZORD - the New Zealand Organisation for Rare Disorders

Time for an urgent review of the restrictions on Xenotransplantation - Press release 5 August 2005.

News of significant success in pre-clinical studies on an animal model of Huntington's disease by New Zealand company Living Cell Technologies Ltd, adds strongly to other very good reasons for a review of the current restrictions on Xenotransplantation medical research. Click here for a NZ Herald article on this development.

LCT uses live cells from pigs in its experimental therapy for HD, specially encapsulated in material that prevents immune rejection by the patient. This process is very similar to the treatment it has successfully used in clinical trials to treat people affected by diabetes. However concern about possible transfer of animal diseases to humans led to tight restrictions on this type of research in many countries several years ago. LCT has conducted the present trials in the United States.

The rationale for the restrictions on this technology was severely dented when the researchers who originally posed the concerns (C Patience and others), published further research in 2004, and again in 2005, which significantly reduces the original concerns and endorsed the continuation of controlled clinical trials.

In January this year our Bioethics Council launched a discussion booklet on the cultural, spiritual and ethical aspects of Xenotransplantation and commenced a public dialogue on this type of biotechnology. Details of this can be found on the website of the Bioethics Council. In May 2005, NZORD submitted to The Bioethics Council that the debates were not identifying any issues of such magnitude that justified restriction of research or clinical trials of Xenotransplantation. Click here for NZORD's submission to the bioethics Council and for the detailed submission of Diabetes Youth New Zealand, whose submission we endorsed.

The Bioethics Council is yet to produce its report, but it is most unlikely to recommend any restriction on xenotransplantation cell therapy. Also, the Council made it clear during the public dialogue that it was not considering the safety regulation - just cultural, spiritual and ethical matters. A review of the safety regulation should be commenced urgently so these two aspects can be considered in parallel, rather than have things considerably delayed by one review following the other.

The reported success of LCT's pre-clinical studies, the disease-free status of the pigs used to source the cells, and the growing body of supportive scientific literature on the topic, are very good reasons for the safety restrictions on Xenotransplantation clinical trials to be reviewed. New Zealand ought to be bringing its regulations into line with the USA where controlled clinical trials are permitted.

It is ironic indeed that a treatment method with huge promise in treating a number of very serious diseases, and some success in early trials, cannot readily be further trialled here in the country where it was originally developed.

ENDS

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