TISSUES FOR RESEARCH AND TESTING T Why human cells and tissues are needed for research he use of human cells and tissues can help us to understand the complexity and functioning of human body systems and their control mechanisms. It can also provide information which is directly relevant to human diseases and their treatment, where studies on human volunteers would not be permissible. Moreover, it can avoid the problem of species differences, which can lead to misleading conclusions when laboratory animals are used. In addition to facilitating the development of human medicines, human cells can also be useful in testing the safety and efficacy of many types of chemicals and products, such as foods, pesticides, vaccines, cosmetics and various household products. E Using cells and tissues instead of animals xperimental animals, such as rats, mice, guinea-pigs, rabbits, dogs, cats and non-human primates, have historically been used being conducted to develop appropriate replacement alternative methods, including tissue culture (in vitro) procedures. extensively for research and testing, although much work is now C The benefits of using isolated cells and tissues ultured cells and tissues can be used in experimental and test procedures which could not be applied to the whole body, but it must be remembered that differences in responses may result from the absence of the control systems which work at the whole-body level. The use of cells and tissues from humans, rather than animals, avoids the problem of species differences (see above). Efficacy – how effectively a substance produces the desired result. In vitro – ‘in glass’, i.e. experiments undertaken outside the body of an animal, such as cell cultures. Glossary Alternative – a procedure which can replace the need for animal experiments, reduce the number of animals required, or diminish the amount of pain or distress suffered by animals in meeting the essential needs of man and other animals. T Types of human cells and tissues obtained he kinds of organs and tissues that can be obtained for use in as well as heart valves, blood vessels and blood cells. research include the skin, eyes, liver, placenta, lungs and kidneys H Sources of human cells and tissues uman cells and tissues are normally obtained directly from Patients undergoing routine operations, including plastic surgery, can donors in four main ways: (a) from patients undergoing routine elect to donate tissue such as skin, for research projects. New mothers surgical operations; (b) from patients who die in Intensive Care can also donate their placentas after they give birth. Patients who die Units; (c) from patients who die in Accident and Emergency Units; in Intensive Care Units are classified as potential heart-beating donors. and (d) during post-mortem examinations. The use of organs and In such cases, tissues can, with permission of the next-of-kin, be taken tissues for transplantation must have the highest priority, but for research purposes when the patient is declared to have undergone where they are unsuitable for this purpose, their use for research brain stem death. It is also possible to retrieve full-thickness skin tissue, can be considered. usually from the abdomen, up to three days after death, during postmortem examinations. Post-mortem examination – an examination of a dead body to discover the cause of death. Brain stem death – an irreversible cessation of the integrated functioning of the entire unpaired subdivision of the brain. Glossary Transplantation – taking tissue or a whole organ, such as a kidney, from a donor individual and surgically introducing it into the body of a patient to replace a defective tissue or organ. T Acquiring human cells and tissues he amount and variety of human tissue that can be made In the past, human cells and tissues for research and testing have available for research purposes is greatly limited by legal, ethical, often been obtained in an informal way. This has restricted the cultural and practical factors. general availability of such material, and has caused problems, particularly when donors or relatives were not asked for their There is a formal system in the UK for obtaining human tissue for informed consent in an acceptable way. Obtaining informed medical purposes, that involves transplant co-ordinators and consent involves providing a written statement of how and why the couriers who work in conjunction with surgical staff at hospitals. tissues and cells would be used, disclosing any potential risks to Transplant co-ordinators can often assist in the supply of tissues the donor (or the relatives), followed by an opportunity for further and organs that are unsuitable for transplantation or are surplus to discussion, so that the donor (or the relatives) can freely make a other medical requirements. personal and educated decision. I Human research tissue banks t is advantageous to have a formal procedure for acquiring, according to demand. The tissue can be monitored for disease status processing and distributing human tissue. To take account of and other properties. Also, tissue banks can demand that researchers important ethical, legal and scientific requirements, human research have obtained ethical approval for their work. tissue banks are being established in several countries, including the UK. All human cells and tissues for research and testing should be accounted for by logging tissues onto a computerised database, in Tissue banks can establish call centres, so that tissue can be collected order to monitor their use and distribution. Donor confidentiality can be rapidly and safely. Human tissue banks are staffed by people who can maintained by using an anonymous tracking system. process the tissues according to the specific requirements of individual researchers, and can maintain stores of tissue to be supplied T Safety issues here are potential safety problems due to possible contamination of tissues with disease-causing viruses, such as HIV and hepatitis. It is not possible to screen living patients for these diseases without their consent. Some examples of how human cells and H tissues are used uman tissues can be used in many different ways, ranging from fundamental studies conducted to gain an understanding of the structure and function of human cells in health and disease to Studies on human tissues are needed as alternatives to using efficacy and safety testing. Both types of studies can also involve human volunteers, as well as to replace experiments to see how substances might be altered chemically in the use of animals. This is because more the body, as a result of enzyme action (metabolism), especially by needs to be known about how a new using human liver cell models. chemical or medical treatment will affect humans before clinical trials in humans are Also, human cells can be used to model the absorption of conducted. Such studies can reduce the chemicals and their passage across and through various barriers in chances the body, such as the intestinal wall, the blood-brain barrier threatening toxicity, like that seen when a (passage into the brain) and the skin (e.g. with human skin models). new antibody treatment for leukaemia, In this way, many cosmetics products and their ingredients are now TGN1412, was tested on six volunteers in being assessed for toxicity, such as skin irritation. March 2006. of unexpected and life- In safety and efficacy testing, once the first studies with human cells in culture have been completed, subsequent tests might involve animals and also volunteers and patients. However, these later investigations are often conducted only on those chemicals that have performed satisfactorily (i.e. that have the desired therapeutic activity without toxicity) in the earlier tests. Ingredients – substances that are used to make a finished product. Irritation – reversible damage to tissues, such as the eye and skin, causing redness and soreness. T Glossary Metabolism – chemical and physical processes within the body that alter a chemical. Conclusions he use of human cells and tissues can provide the basis for the However, the main constraint on using human cells and tissues is development of very useful and predictive methods for replacing a their safe, reliable, efficient and ethical supply to researchers. The wide range of animal experiments. In particular, the use of human advent of human research tissue banks should help to meet these cells and tissues can be more beneficial than using animals by needs, but it is crucial that volunteers, patients and relatives of providing more-relevant information. deceased individuals are encouraged to donate tissues, following receipt of the necessary information and reassurances and are convinced that the proper procedures will always be followed. FRAME Fund for the Replacement of Animals in Medical Experiments FRAME was founded in 1969, to promote the concept of alternatives to the use of laboratory animals in medical research and toxicity testing. FRAME is dedicated to the scientific development, acceptance and use of replacement alternative methods, on which the long-term aim of eliminating the need for animal experiments altogether unavoidably depends. FRAME recognises that animals may still have to be used for some essential objectives to be achieved, and considers that the most immediate prospects for progress lie in reducing their numbers and in refining the procedures applied to them, so as to minimise their suffering. Russell & Burch House, 96-98 North Sherwood Street, Nottingham NG1 4EE Telephone: 0115 958 4740 • Fax: 0115 950 3570 • email: [email protected] • website: http://www.frame.org.uk Regd. Charity No. 259464 FRAME© Focus/HumCells/v2/06 Production by The Art Department, Nottingham
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