Health Care

By:Graham Drage

Stem cells are cells found in most, if not all, multi-cellular organisms. They are the building blocks of the body which have the ability to renew themselves through mitotic cell division and differentiate into a diverse range of specialised cell types such as muscle or nerve cells. Scientists are learning how to 'tweak' stem cells so that they can be used to treat degenerative diseases etc.

When IVF was first announced it was frowned upon but now it is accepted as being a normal and fairly routine procedure. Given enough time to raise awareness of the benefits of stem cell therapy it is anticipated that, like IVF, it will become accepted practice. In fact, cell therapy is currently being used for the treatment of patients with leukaemia so already there is a certain level of public acceptance for this type of treatment.

Patient groups such as the Parkinson's Society are encouraging the use of stem cell therapy by the very nature of the disease itself. It is those people suffering from slowly degenerative diseases who are most likely to push for clinical trials in man. 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. 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.

The commercial aspect of stem cell therapy should not be overlooked. There are existing 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] This one example demonstrates a considerable saving and most importantly, improvement to the patient's quality of life.

Stem cell activities are regulated by different professional bodies within the EU which has resulted in a somewhat fragmented approach with decisions having to be made on a national basis. This is time consuming, inefficient and costly. Currently there are proposals being debated in the European Parliament which, hopefully, will go some way to resolving this. It has taken many years to get to where we are today and it is likely to take at least another decade before we reach any level of true harmonisation.

Europe isn't on its own in having a fragmented approach to stem cell therapies. America's regulations vary considerably from State to State and under the Bush administration 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 with Obama at the helm of the US 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.

[1] Source: Professor P Coffey, The London Project to Cure Blindness: Stemming Vision Loss with Stem Cells

[2] Source: San Francisco Chronicle, 29 November 2008

Greer Deal is the Founder and CEO of Global Regulatory Services Ltd. which has been created to offer regulatory advice and services to a wide range of industry sectors. Her website is www.globalregulatoryservices.com and she can be contacted on +44(0) 1353 774000.

Source: http://www.articlealley.com/article_784536_17.html