Stem cell research still in experimental stage

THE POINT IS

Dr Derrick Aarons

Sunday, November 10, 2013

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STEM cell therapy and stem cell research has been in the news recently.

To understand the issues, we need to comprehend the difference between therapy and research. The word 'therapy' implies treatment of patients and usually involves medication or procedures that are widely accepted as being beneficial
to persons.

Worldwide, the work with stem cells is still regarded as being in the 'experimental stage' and is not an established treatment being offered by doctors. Stem cell research is a scientific enterprise specifically designed to discover the safety and effectiveness of particular cells in disease processes.

This research endeavour goes through four stages -

Phase 1 involves animal studies:

Phase 11 involves a small group of healthy people where the dosages, effects and safety of the particular agent is evaluated;

Phase 111 involves the evaluation of its purity, effectiveness and safety in large groups of people who have the particular disease, and only if the agent proves to be safe and effective in those persons, does it go on to Phase IV.

Phase IV — general market availability with ongoing safety monitoring in the market place.

In a research publication in Heart Online First on March 22, 2013, entitled Current outlook of cardiac stem cell therapy towards a clinical application", the researchers informed that 50 phase 1 & 11 clinical trials have proven that the use of adult stem cells to treat heart disease has been feasible and safe up to five years.

However, research is now needed in phase three trials to answer many questions, including 'does stem cell therapy result in reduced mortality'; 'what is the timing to obtain a maximal effect'; and 'which set of cells is better'?

Confirming that the issue is still in the experimental phase, the researchers stated 'stem cell therapy is now entering the arena of phase 111 clinical trials, and several challenges need to be addressed, in order to realise the full potential of stem cell therapy in cardiovascular disease'.

In its Consumer Health Information entitled FDA warns about Stem Cell Claims, the Food and Drug Administration (FDA) of the United States warned that the hope that many patients have for cures not yet available may leave them vulnerable to certain providers of stem cell treatments that are illegal and potentially harmful (see https://mail-attachment.googleusercontent.

FDA regulates stem cells in the USA to ensure that they are safe and effective for their intended use. The FDA has approved only one stem cell product, Hemacord, derived from the cord-blood of newborns, and is used in patients with disorders affecting the body's blood-forming system.

The FDA has, however reviewed other stem cell products for use in investigational studies. Until these studies are completed, we will not know if they are effective and safe for general use in persons.

In its advice to consumers, the FDA recommends talking to your doctor before agreeing to be a part of an FDA-regulated clinical study. Even if the stem cells are yours, there are safety risks, particularly when they are manipulated after being removed from your body.

Potential safety risks exist when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body. Cells in a different environment may multiply, form tumours, or leave the site you put them in and migrate somewhere else — hence the need for proper regulation.

The FDA states that it does not regulate stem cell treatments outside the USA, and has little information about foreign establishments, their regulations, if any, or their stem cells products.

Jamaica's medical regulatory framework does not have any 'investigative arm' to discover what is occurring around our country. It is not pre-emptive. It is reactive and depends on people who have been harmed or feel 'wronged' to report such matters to the central authority.

Individuals therefore have to be very cautious about matters concerning their bodies and their health, and should seek the advice of knowledgeable professionals before embarking on possible risky endeavours that have not yet gained widespread acceptance.

'Potential' means possible in the future, it does not mean 'proven
and safe'!

Dr Derrick Aarons MD, PhD, is a Consultant Bioethicist/Family Physician - a Specialist in ethical issues in medicine and research, and was a founding member of the National Bioethics Committee of Jamaica.


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