Potential ethical dilemmas could stymie the growth of the engineered tissue industry in South Africa, with moral question marks hovering over aspects like the possible use of human stem cells, and even pitfalls like intellectual property issues, writes Professor Melanie Labuschaigne, member of the board of Bone SA.
Much like human blood, human tissue – including bone, skin, heart valves and corneas – is used in a number of surgical applications to treat patients for conditions including severe burns, torn tendons and ligaments, and to repair musculoskeletal structure such as teeth, skin and spinal components.
And just like human blood, there is currently no synthetic alternative that matches that power of real human tissue, but the possibilities for engineered tissue are growing by the day and showing immense promise.
To understand why tissue engineering is an increasingly important focus area for the biomedical sector, it is useful to unpack the current need for human tissue among patients in this country.
At any given time, some 2 780 South Africans need an organ to save or dramatically improve their quality of life. The demand for human tissue for transplantation means this number may increase to around 5 000 people relying on donors for these lifesaving anatomic materials and organs.
Factors driving this market include an escalation in acute diseases, the introduction of highly sophisticated tissue products, and an increase in the number of tissue banks.
Yet, tissue and organ donation does not readily happen in South Africa. Only around 1.4 per million South Africans are registered organ donors. And while this number may be attributed to a number of factors, including a lack of awareness and understanding, cultural stigma and even apathy, boosting the numbers of registered donors is not the only way to tackle this issue.
Engineering a new medical future
Tissue engineering is one of the most dynamic biomedical disciplines, with enormous potential to positively affect the lives of countless patients by assembling functional constructs that restore, maintain or improve damaged tissues or whole organs, as per the National Institutes of Health definition.
In fact, one of the key advantages is its ability to regenerate a patient’s own tissue and organs, which eliminates the issue of biocompatibility.
In South Africa, where the chronic disease burden costs the economy millions each year, tissue engineering has the potential to offer an integrated solution that eases the pressure on the healthcare sector and ultimately ensures better patient outcomes.
But it is not free of ethical challenges, and it’s crucial that these questions and concerns are identified at an early stage. Not only is it part of science’s responsibility towards society, it is in the best interest of the field itself.
The need for ethico-legal oversight is driven by the obligation scientists, researchers, engineers and healthcare professionals have to protect patients, manage medical risks and safety issues, and comply with the minimal legal, ethical, scientific and medical standards set in various regions and jurisdictions.
In the South African context, both research and anecdotal findings point to the need for ethico-legal requirements that address the concerns below.
Some of the most controversial challenges are:
- Because some tissue products may require the use of embryonic stem cells, moral objections may arise, as it may require that human embryonic stem cells be sourced by means of the destruction of a five to seven week-old embryo;
- To develop genetically identical or compatible tissue for transplantation, it may be necessary to rely on a process known as somatic cell nuclear transfer, which not only requires the use of human embryonic stem cells, but is furthermore controversial because it constitutes a form of human cloning; and
- The proliferation of the cells required in some tissue products poses challenging intellectual property questions relating to the patenting of living things, including the right of the donors of the cells to co-own or benefit from the sale of products developed using their cells or tissues.
The nature of very advanced tissue engineered products makes it difficult to determine appropriate regulatory frameworks for these products, especially those that are not developed for widespread use, as is the case with ordinary pharmaceutical products.
Regenerative medicine, which includes tissue-based or tissue-engineered products, is currently not regulated in South African law. Clarity is required on which of these products should be regulated as biological medicines, medical devices, cell-based products, or possibly even gene therapy.
It would be remiss to not acknowledge that tissue engineering as a vehicle for supplying medical products to South Africa and other low- and middle-income countries is still in its infancy. Having said that, Vitanova, the country’s latest and most state-of-the-art tissue engineering facility, is doing a great job of fulfilling a need for allograph bone and tissue, while the science and ethics around tissue engineering matures and catches up.
It is only with appropriate guidelines and a robust legal framework in place that tissue engineering will reach its potential and measurably improve the quality of life of those patients who would otherwise have no option but to wait for a tissue or organ voluntarily donated.
Professor Melodie Labuschaigne is Professor in Medical law and Ethics in the Department of Jurisprudence in the School of Law, University of South Africa. She is a former Director of the School of Law and Deputy Executive Dean of the College of Law at UNISA. She has published numerous articles on the legal regulation of stem cell research and human tissue, genomic and genetic research, gene editing and assisted reproduction, in local and international law journals and has presented many local and international conference papers. She serves on the Bioethics Advisory Panel advising the president of the SAMRC, and was appointed by the Minister of Health in December 2020 to serve as the legal member on the National Health Research Ethics Council.
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