Stem cell treatments can go wrong

Dr Derrick Aarons

Saturday, March 25, 2017

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Stem cells are the foundation of all our body cells before they differentiate to become specialised cells that grow into our tissues and organs, such as kidney cells, muscle cells, nerve cells, and so on.


They commonly come from two sources: The embryo (embryonic stem cells formed in early development after the human egg is fertilised by a sperm); and adult tissue (adult stem cells, such as those existing in bone marrow to later differentiate to form red blood cells, white blood cells and other components of the blood).


The use of human embryonic stems cells for treatment or research is often frowned upon by some people, as they regard the human embryo as a person that should not be discarded after such endeavours. Consequently, much scientific work has recently been focused on the use of adult stem cells.


THE USE OF STEM CELLS


Stem cells may be beneficial in treating diseases that are amenable to cell replacement. However, this is still a young science, and belief that a particular treatment helps two or three people does not convince the scientific community or the whole society that the treatment will work for everyone so afflicted.


Scientific ‘proof’ comes from conducting clinical trials, the international ‘gold standard’ — often involving hundreds of people so afflicted and comparing them with an equivalent number of people not afflicted — to determine whether a treatment really works for those who receive it.


Whilst many stem cell research projects are currently being conducted in various centres around the world to determine whether they produce benefits, and what may be the possible risks involved, there are also medical clinics that are using stem cells not in a registered research project, but rather in the actual treatment of affected people.


TREATMENT CAN CAUSE HARM


A recent report in the highly respected New England Journal of Medicine informed that three elderly women in Florida had been blinded by an unproven treatment.


They had signed up for a purported clinical trial in 2015 — for which they had to pay US$5,000 each. Before surgery, the vision in their eyes varied from 20/30 to 20/200, but within one week after surgery, they experienced a variety of complications, including vision loss, detached retinas and bleeding into their eyes, resulting in total blindness.


The authors of the article from the Standard University School of Medicine sought to make patients, doctors and the various regulatory agencies aware of the risks of such a minimally regulated, patient-funded research. It stated that some clinics appeal to patients that are desperate for care and who hope that stem cells will be their answer, but as in the case of these women, some of these current enterprises are very dangerous.


At this particular clinic, fat cells were taken from the patients’ abdomens and processed to obtain stem cells which were then injected into their eyes. The patients reported that the entire process took less than one hour. The patients had both eyes treated at once, even though most doctors would opt for a conservative approach to observe how the first eye responds.




THE NEED FOR THE REGULATION OF RESEARCH


The article stated that while there is a lot of well-founded evidence for the positive potential of stem cell treatment for many human diseases, such treatments should be conducted in a well-designed clinical trial based on pre-clinical research.


The treatment done for the women lacked nearly all the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, the involvement of a ‘control’ group of people and a treatment group, the safe collection of data, the masking of clinical and patient groups, and plans for follow-up.


Clinics offering stem cell treatments exist in Jamaica, The Bahamas and Cuba. However, while both The Bahamas and Cuba have developed regulations that stipulate in law the conditions to be met for stem cell treatments and research within their jurisdictions, Jamaica has developed no such regulation.


THE MEDICAL ACT DOES NOT PROVIDE PROTECTION


The Medical Act of Jamaica was passed in 1976, but does not mention or provide any guidance or protection regarding research with human participants.


Its focus was to: Register medical practitioners; appoint examiners to conduct exams for people applying for registration, and ensure the maintenance of proper professional conduct by practitioners.An amendment in 2004 added the requirement of continuing medical education for practitioners.


Guyana and St Lucia are the only countries in the Caribbean that have joined the progressive countries who all have legislation governing research with human participants within their borders. Regulations should stipulate the requisite conditions, including that treatment and research be monitored by an appropriate ethics committee to meet all international standards.


Without this, vulnerable people seeking health benefits will unknowingly continue to subject themselves to risks of harm without the protection that proper regulations can provide.





Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the Ethicist at the Caribbean Public Health Agency (CARPHA). (The views expressed here are not written on behalf of CARPHA)


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