The words "stem cell research and therapy" evoke a number of responses. In emotionally vulnerable patients, a sense of hope. In scientists, a great deal of excitement about future prospects. In the case of legal experts and ethicists, a need to ensure that patient safety and a spirit of distributive justice are maintained. And in the minds of entrepreneurs, an opportunity to develop a profitable business.
Stem cells are the building blocks of our bodies. They are able to differentiate into the more that 200 cell types that make up our bodies. From a fertilised egg to a fully fledged human being which contains billions of cells, the purpose of stem cells during development in the womb is to ensure normal structure and function.
In postnatal life, stem cells replace those cells that have been damaged by wear and tear or by disease.
In research, stem cells are at the cutting edge of science, with regular breakthroughs being announced in the field. By 2012, it was estimated that there were close to 100,000 active stem cell researchers across the globe.
Massive funding is being directed globally into research which continues to provide hope to millions of patients.
Stem cell therapy translates the research findings into potential cures for many diseases. For instance, for more than 50 years, bone marrow transplants – also known as hematopoietic stem cell transplants – have been used to treat patients with blood cancers such as leukemia and blood disorders such as sickle cell disease and thalassemia.
When a person with cancer undergoes conditioning chemotherapy to destroy the cancerous cells in the body, in the process this treatment also destroys the patient?s own stem cells. Bone marrow transplants are used to replace these stem cells. This form of treatment is universally employed, and accepted.
More recently, skin grown from stem cells has been used to treat extensive burns and stem cells from fat (adipose tissue) have been used as tissue fillers.
The reality of stem cells versus future promise
Stem cell treatment has saved many lives. But there are also elements of stem cells that have been mired in controversy.
As a result of stem cells becoming a buzzword, there has been a proliferation of websites offering dubious treatments, luring people with incurable diseases who are emotionally vulnerable. There is rarely any form of control over what these clinics place on their websites, let alone the treatments they offer.
Aside from bone marrow transplants and stem cells used for burns, almost all other conditions for which stem cells are advertised to provide a cure are still in an experimental stage. Globally, there are hundreds of legitimate clinical trials underway to assess the effect of stem cells in a variety of conditions including heart disease, spinal cord injury, blindness and Parkinson?s disease, to name a few.
But, in these cases, the road which finally joins the healing properties of stem cells to the approved use of these cells on a routine basis is long and arduous.
Clinical trials need to be undertaken before a treatment can become part of routine medical practice. They must be registered with the relevant national body in the country where they are taking place. Clinical trials also need to be peer reviewed via a registered ethics committee or an institutional review board.
And although rarely mentioned explicitly in legislation or guidelines, patients who receive experimental treatments should not have to pay for these treatments.
Breaching the law on multiple fronts
For most stem cell treatments which have not undergone clinical trials, patients are subjected to therapy which defies the basic ethical and legal principles of the medical profession. Some treatments are blatantly unsafe, such as the infusion of embryonic and animal-derived stem cells into humans.
But practitioners who provide these unproven treatments argue that:
Countries without adequate legislation cannot curb unethical practices and financial exploitation of patients using unproven stem cell treatments. In these countries, unscrupulous medical practitioners providing these therapies often identify the gaps in the law and then head straight for them, using legal tactics and devious interpretations to justify their activities.
Regulating stem cell treatment
To ensure the safety of stem cell treatments and to limit exploitation of vulnerable patients, several measures can be undertaken. These include establishing appropriate legislation, ensuring that this legislation is enforced, and educating the public.
Ethical advertising standards also need to be enforced to limit the dissemination of false information. And patients should feel they have the freedom to approach their medical practitioners for advice on how to proceed.
Without an adequate legislative environment or the enforcement of existing legislation, the medical industry is at risk of facing legal challenges from unsatisfied or damaged patients. This is likely to slow down advances in the field, although it will also provide much needed case law which, due to the relative youth of the field, is still lacking in many countries, including South Africa.
But the outcome could also include a knee-jerk reaction that results in excessively prescriptive legislation that limits research on valuable ethically and scientifically approved projects as well as the translation of research findings into useful products and services.
This article based on a paper published in a special South African Medical Research Council Flagship edition of the South African Journal of Bioethics and Law.
Written by Michael Sean Pepper, Director of the Institute for Cellular and Molecular Medicine at University of Pretoria; and Nicolas Novitzky, Professor of Haematology at University of Cape Town.
Disclosure statement: Michael Sean Pepper receives funding from the South African Medical Research Council, the National Research Foundation of South Africa and the National Health Laboratory Services Research Trust. Nicolas Novitzky receives funding from the National Research Foundation and the Medical Research Council and he is a board member of the South African Bone Marrow Registry.
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