Session A1: The Acquisition and Use of Human Cells in Research and Testing

Chairs: Robert Combes (UK) and Jan van der Valk (The Netherlands)

A1: The Use of Human Cells in Biomedical Research and Testing
Robert Combes. FRAME, Nottingham NG1 4EE, UK. bob@frame.org.uk.

Using human cells has many advantages: 1) species extrapolation is obviated; 2) different cell types can be used with many techniques to study diverse phenomena in tissue culture; and 3) they can be grown as organotypic cultures to facilitate the extrapolation from cells to whole organisms. Human cell lines have been available for many years on an ad hoc basis from individual researchers, and also from recognized culture collections. There are three main problems to using primary human cells: 1) their short longevity and tendency to de-differentiate; 2) a potential risk to health; and 3) ethical considerations.

The safe and controlled acquisition of surgical waste and non-transplantable human tissues has been facilitated by the establishment of several human tissue banks. A European centralized network of banks is being established and ESTIV is involved in this initiative. Other problems might be addressed by immortalizing cells, and by using specialized media and stem cells.

A1: Dutch Guidelines for the Use of Human Tissue in Research
Jan van der Valk. NCA, Dept. of Animals & Society, Faculty of Veterinary Sciences, Utrecht University, NL-3584 CH Utrecht, The Netherlands. valk@as.vet.uu.nl.

There is an increased attention for the use of human tissue in research, for scientific reasons and to replace or reduce animal use. Sources for human tissue can be post-mortem material, non-transplantable donor organs, or leftover tissue after a surgical procedure. Recently, in The Netherlands, the Code "Goed Gebruik" (proper use) was published, which provides guidelines for the use of leftover tissue in research. Leftover tissue is defined as tissue that is stored or used for other purposes than for which it was removed. The code dictates that leftover tissue can only be used for research purposes on the basis of an agreement with the person who procured the tissue, which includes, among other items, the consent procedure that was used and the research protocol. Also covered is whether and how the patient is informed when the course of study new information is obtained with regard to the health status of the donor. The code was developed with the aim to respect the privacy of the donor and to standardize consent procedures between procuring institutions.

A1: Human Cells and Tissues for Research: Setting Up the European Network of Research Tissue Banks
Dariusz Sladowski. Department of Transplantology and the Central Tissue Bank, Centre of Biostructure Research, Medical University of Warsaw, Chalubinskiego 5, 02-004 Warsaw, Poland. dslado@ib.amwaw.edu.pl.

Availability of standardized human material is the key issue for the development and successful introduction of new in vitro toxicological methods¹. Standardization and safety control can be guaranteed only by specialized institutions that can secure an ethical, safe, and reliable supply of human cells and tissues to researchers. The ethical issue is especially important from the point of view of medical professionals, as the use of human cells and tissues for research must not, in any case, affect the number of people willing to donate for transplantation. Cultural and legal differences among European countries present a very difficult situation for the development of research tissue banks. This highly demanding task can be accomplished by setting up a network of tissue banks across several European countries. The European Network of Research Tissue Banks (ENRTB) will serve as a multinational body that will work under harmonized ethical and technical guidelines².

Such a structure will enable secure transfer of processed material between member countries and will guarantee that the use of human cells and tissue for research will not affect the donation system for transplantation. The system will incorporate not only specialized research tissue banks (UK HTB, Peterborough HTB) but also existing tissue banks working for clinical purposes. This will ensure that all human material available to tissue banks will be primarily regarded as a material for transplantation and will be classified for research purposes only when disqualified for clinical use. The network will also secure standardization of distributed cells and tissues and safety of the material. Cells and tissues used for in vitro toxicology should have preserved live functions and should respond in the same way to the standard chemicals. It is also essential that the material match a specific target population (age, sex, ethnic group, genetic and metabolic profile). Setting up a research tissue bank creates new problems, which are being approached in our TB.

¹Anderson, R., et al., Altern Lab Anim, 1998, 26(6):763-77.
²Anderson, R., et al., Altern Lab Anim, 2001, 29(2):125-34.

A1: The Establishment of the UK Human Tissue Bank
S. Orr and J. Trafford. UK Human Tissue Bank, De Montfort University, Leicester, LE1 5XY, UK. samantha@ukhtb.org.

The UK Human Tissue Bank was established in 1999 to provide biomedical researchers with an effective, transparent, and ethical supply of human tissues. We collect and process non-transplantable human tissue from cadaveric donors and surgical tissues surplus to diagnostic requirements, and distribute to researchers working in UK Universities, medical institutions, and the pharmaceutical industry. The UKHTB has gained approval from UK National Health Service Ethical Committees for the receipt of human tissues and transfers donated tissues to researchers with allied approval who additionally agree to the scrutiny of the end use of tissue by UKHTB. All donations are made with the informed consent of the donor family or patient. In this way, all donations are traced from source to end-use. The UKHTB operates under a not-for-profit policy and employs a method of cost recovery to recoup processing, staff, and transport costs; the tissue itself is not subject to a cost. We are confident that improved access to human tissue models results in more relevant results being ultimately available for clinical practice.