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The future of Stem Cell therapy in healthcare.What are Stem Cells?They are the building blocks of the body found in most multi-cellular organisms. They can renew themselves through mitotic cell division and develop into a diverse range of specialised cell types such as muscle or nerve cells. What is their potential use?Scientists are learning how to 'tweak' stem cells so that they can be used to treat previously untreatable conditions. In addition, we have an ageing population which is yet another reason why there is a greater demand for research into cell and organ replacement therapies.
Ethics and Public Acceptance.Patient groups such as the Parkinson's Society are encouraging the development and clinical trials of stem cell therapy by the very nature of the disease itself. It may be too late to help them but they are keen to help treat subsequent sufferers with the aim of eradicating the disease altogether. When IVF was first announced it was controversial but now it is accepted as a normal and relatively routine procedure. With increased awareness of the benefits of stem cell therapy it is anticipated that, like IVF, it will become accepted practice. It has already started to gain acceptance for the treatment of patients with leukaemia. Commercial Aspects; Potential Cost Savings.Existing, expensive, treatments which, in the future, could be replaced with stem cell therapy. For example, the current treatment for patients with age-related macular degeneration (AMD) is a 4 to 6 weekly injection in the diseased eye at a cost of £1,200 per injection. These injections could be replaced with the use of embryonic stem cells. A procedure which would take 40 minutes and last 2 to 3 years at an approximate cost of £5,000.1 Hence this would save c£26,000 over three years and improve the patient's quality of life.
Regulation and Politics.Many EU bodies are involved in regulation resulting in a fragmented, time consuming, expensive and inefficient approach, with decisions having to be made on a national basis. Proposals being debated in the European Parliament to resolve this. It is likely to take at least another decade before we reach any level of true harmonisation.
Europe isn't alone! American regulations vary considerably from State to State and federal funding for stem cell medical research has been extremely limited. The new US President, Barack Obama, however, has stated that he will lift the restrictions imposed by President Bush. "I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations," he said. As president, Obama says he will guarantee that all research on stem cells is conducted "ethically and with rigorous oversight."2
Europe is waiting to see what happens because it is likely that whatever happens in America will also have an impact on regulations within the EEC.
In the meantime, it is important that we do not lose sight of the fact that the research and development of stem cell therapies has huge potential for human health. It took many years for IVF to become a normal part of our healthcare system. Given enough time to raise public awareness and to harmonise legal and regulatory systems, stem cell therapy will also become accepted treatment. In the transition phase regulatory compliance consultants like GRS continue to monitor and offer advice to organisations at the leading edge of healthcare technology.
1Source: Professor P Coffey, The London Project to Cure Blindness: Stemming Vision Loss with Stem Cells. 2Source: San Francisco Chronicle, 29 November 2008
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