Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions.

Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources.

Ethical, legal, and societal issues and recommendations for controlled and uncontrolled DCD.

This report deals with organ retrieval procedures in both controlled and uncontrolled DCD, looking at the ethical, legal, and psychosocial aspects during the different phases of the process. A recently published report by the UK Donation Ethics Committee (UKDEC) has served as an important reference document to outline the steps in the controlled DCD patient-donor pathway (Academy of Medical Royal Colleges. UK Donation Ethics Committee.

How to increase organ donation: does opting out have a role?

Every country needs to increase the number of deceased organ donors and the potential impact of a change to opting-out legislation remains unproven, despite the apparent association between opting out and higher donor rates. However, the Spanish model--so successful in Spain and many other countries--is not based on a requirement for opting out, and, in the UK, deceased organ donation has increased by 25% in 3 years through implementation of a series of recommendations that have transformed the infrastructure of donation. A major review of opting out concluded that it is not appropriate for the UK at this time.

A New UK 2006 National Kidney Allocation Scheme for deceased heart-beating donor kidneys.

In 2004, it was agreed that a new allocation scheme for kidneys from deceased heart-beating donors was required in the United Kingdom to address observed inequities in access to transplant. The 2006 National Kidney Allocation Scheme (2006 NKAS) was developed to meet agreed objectives and preparatory work included a review of the criteria for human leukocyte antigen (HLA) matching and simulation evidence about the effectiveness of alternative schemes. ALGORITHM FOR 2006 NKAS: The 2006 NKAS gives absolute priority to all 000 HLA-A, -B, -DR-mismatched patients and well-matched pediatric patients (<18 years), and then a points score defines priorities for allocation with waiting time being most influential.

Factors influencing outcome after deceased heart beating donor kidney transplantation in the United Kingdom: an evidence base for a new national kidney allocation policy.

Background: Outcomes after deceased heart beating donor kidney transplantation are good, but survival rates vary according to a number of donor-, recipient-, and transplant-related factors. This comprehensive analysis of transplant outcomes was undertaken to inform development of a new Kidney Allocation Scheme.

Methods: A complete case analysis of the outcome of kidney-only transplants in the United Kingdom, 1995 to 2001, was undertaken using Cox regression modeling.

Impact of the 1998 UK National Allocation Scheme for deceased heartbeating donor kidneys.

Introduction: National and regional strategies for allocating deceased heartbeating (DHB) donor kidneys to patients awaiting transplant are of great importance and have major implications for patients and healthcare systems. We describe the rationale for the 1998 National Kidney Allocation Scheme (1998 NKAS) and its impact on renal transplantation in the United Kingdom over 5 years.

Methods: The 1998 NKAS was based on three tiers of patients defined by human leukocyte antigen (HLA) mismatch.

The UK scheme for mandatory continuous monitoring of early transplant outcome in all kidney transplant centers.

Mandatory continuous monitoring of early transplant outcome with centralized oversight was introduced in 2004 for all 23 UK adult kidney transplant units. Risk-adjusted cumulative sum charts are used to assess 30-day graft and patient survival against past performance for each center, and change in transplant center performance is assessed by tabular cumulative sum charts. The monitoring scheme has performed as predicted from simulations used to establish outcome thresholds and has been validated by comparison with 1- and 5-year outcome data for all UK transplant centers.

Early experience of paired living kidney donation in the United kingdom.

Background: Paired living kidney donation became possible in the United Kingdom in 2006 after the introduction of a new legal framework for organ donation. A national matching scheme was subsequently established and we report the early United Kingdom experience of paired donation.

Methods: A new national matching algorithm was developed for the introduction of paired donation in the United Kingdom.

The effect of mycophenolate mofetil and azathioprine dose on renal allograft outcome in the United kingdom.

Background: Mycophenolate mofetil (MMF) therapy compared with azathioprine has not led to improved long-term renal allograft outcomes perhaps as MMF dose is limited by tolerability and dose reduction is associated with inferior graft outcome. The consequences, however, of dose reduction of mycophenolate mofetil relative to azathioprine have not been reported.

Method: We studied dosing patterns of MMF and azathioprine in the first year after transplantation and their impact on graft outcome after renal transplantation between 1999 and 2002 in the United Kingdom.

Kidney donation and transplantation in the UK from 1998 to 2007.

There are many changes happening in donation and transplantation in the UK and this review provides a baseline against which the success of future developments can be assessed. There has been a decrease in donation after brain death over the 10-year review period, but increases in both donation after cardiac death and living kidney donation. Antibody incompatible transplantation and paired and altruistic donation programmes are starting to have an impact on the number of living donor transplants carried out and are expected to make a more marked impact in the years ahead.

Pregnancy after organ transplantation: a report from the UK Transplant pregnancy registry.

Background: Maternal and fetal complications in pregnancies after renal transplantation have been highlighted in several reports, but information on their main predisposing factors is limited. The U.K.

Renal transplantation in the United Kingdom for patients from ethnic minorities.

Background: To investigate any differences in access to transplant and post-transplant outcomes for ethnic minority patients in the United Kingdom, national data on ethnicity of patients on the waiting list, those receiving a transplant, and deceased donors were analyzed.

Methods: Adult patients and donors were included. Ethnic origin was classified as white, Asian, black, or "other.

Long-term graft outcome with mycophenolate mofetil and azathioprine: A paired kidney analysis.

Background: Randomized controlled trials and U.S. Registry data have demonstrated that mycophenolate mofetil (MMF) reduces acute rejection rates and improves graft survival.

Potential for organ donation in the United Kingdom: audit of intensive care records.

Objectives: To determine the true potential for solid organ donation from deceased heartbeating donors and the reasons for non-donation from potential donors.

Design: An audit of all deaths in intensive care units, 1 April 2003 to 31 March 2005. The study was hierarchic, in that information was sought on whether or not brain stem testing was carried out; if so, whether or not organ donation was considered; if so whether or not the next of kin were approached; if so, whether or not consent was given; if so, whether or not organ donation took place.

Geographic disparities in access to organ transplantation in the United Kingdom.

In the United Kingdom, geographic variations in access to transplantation seem to exist-median waiting time to transplantation ranges between 305 and 1,236 days for kidney recipients, 36 and 73 days for liver recipients, and 66 and 667 days for heart recipients (although this latter example must be interpreted with caution). These variations may result from a number of factors. Different patterns of end-stage organ disease are particularly relevant for patients with kidney failure.