![]() ![]() The source of all material will have to be traceable even if it is anonymised at the point of production. The EU directive will cover selection of donors, testing, and procurement of the starting material for cell lines, tracking cells from donor to recipient, use of a specified coding system, and reporting of adverse events. 7 Thus all laboratories for in vitro fertilisation and laboratories for producing cell lines with therapeutic intent will have to conform to a new standard of quality even more stringent than the current requirements of the Human Fertilisation and Embryology Authority (HFEA). #Animal hype house logo codeAlthough those working with stem cells in the United Kingdom have non-statutory guidance in the form of a code of practice for tissue banks, 6 by April 2006 it will become mandatory for them to comply with the EU directive on tissues and cells. 4, 5 No blood test for vCJD currently exists, and neither does an effective method of inactivating the causative agent.Ĭhange is on the way, however. w4 w5 Tissues have transmitted prions, 3 and the prion that causes variant Creutzfeldt-Jakob disease (vCJD) has almost certainly been transmitted by blood transfusion. ![]() ![]() Transmission of malignant, autoimmune, and infectious diseases by organs, tissues, and cells are rare but well documented events. Expansion of stem cell cultures could allow a single stem cell line to be used for many hundreds, if not thousands of patients, exponentially amplifying the potential risk of disease transmission from a single infected donor. The lessons of the premature application of gene therapy, the devastation caused by HIV transmission to people with haemophilia, the clinical and legal w2 problems resulting from hepatitis C infection through blood transfusion, and the crisis caused by bovine spongiform encephalopathy w3 should all be learning opportunities. The premature use of cell therapy could put many patients at risk of viral or prion diseases unless systems are in place for the appropriate selection and screening of donors and for quality assurance. 2 Even the embryos from which human embryonic stem cells could be derived are still cultured in vitro in the presence of human or animal products. ![]() Stem cells have not yet been grown in the conditions that would be expected for any pharmaceutical product destined for use in vivo. 1 These will require substantial further investment and research. w1Īlthough the number of human embryonic stem cell lines has increased considerably in the past two years, few of these have been well characterised, and large hurdles still need to be overcome to ensure safety and efficacy. Whether this is just hype, and how much hope patients should invest in this technology, are issues being discussed at a public debate in London this week. News reports and promotional material on websites often convey the impression that this therapy is safe and immediately or imminently available. The use of human embryonic stem cells has been hailed as the next major step in the battle against serious degenerative disorders, such as diabetes and heart disease, and for some debilitating or lethal neurological diseases, such as Parkinson's and motor neurone disease. ![]()
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