The regenerative capability of a living creature was recorded as early as 330 BC when Aristotle observed that a lizard could grow back the lost tip of its tail. Since then there have been slow but steady developments in understanding the regenerative capabilities of human beings.
In the last decade, there has been an information explosion in the area of stem cell research. The biological therapy offered by stem cells is likely to revolutionise the entire health care delivery. Is Malta in time to catch up with this evolution?
Human stem cells have raised hopes in the eyes of healthcare professionals and patients seeking repair of injuries to a variety of organs damaged by serious illnesses which are often considered incurable or irreversible. Stem cells are special cells that could develop into blood, brain, bones and other body organs with the potential to repair, restore, replace or regenerate damaged cells. The hope is that such regenerative therapy would reduce associated morbidity and mortality rates.
The clinical therapeutic benefit is evident in the use of blood stem cells to treat diseases of the blood, a therapy that has saved the lives of thousands of patients with leukaemia. Stem cells are also used for tissue grafts to treat diseases or injury to the bone, skin and surface of the eye. The potential of clinical applications for stem cells to treat everything from arthritis to Alzheimer’s disease has emerged but very few stem cell treatments have been proven safe and effective by regulatory authorities.
All medical treatments have benefits and risks. The process by which science becomes medicine is designed to minimise harm and maximise effectiveness. There is a multi-step process involved in responsibly translating science into safe and effective medical treatments.
During this process, scientists may discover that an approach that seemed promising in the laboratory does not work in animals or that an approach that worked in animals does not work in humans. It may be discovered that a treatment effectively addresses symptoms of a disease or injury in humans but carries unacceptable risks.
In 2017, the European Medicines Agency approved the first stem cell therapy made out of the patient’s own stem cells. It is used to treat one of the complications of Crohn’s Disease. Before a stem cell therapy is approved, the agency considers the possible risks of tumour development and rejection of the stem cells, together with the benefit to the patient.
Stem cell therapy is no longer science fiction. It is a challenge for the present and the future
The Malta Medicines Authority has in recent years built up an excellent reputation in the regulatory sciences. The first task undertaken by the authority since 2013 has been to ensure its sustainability while at the same time retaining its prime task of safeguarding the quality, safety and efficacy of medicines for patients in the European framework. The authority moved on to ensure accessibility to medicines by establishing the Medicines Intelligence and Access Unit.
The time has come for our outstanding professionals in the authority to take on innovative tasks involving new and advanced therapies. These are being spearheaded by the Directorate for Advanced Scientific Initiatives, which is supporting the promotion of science as in the case of the regulation of cannabis for medicinal use.
The key to success is linked invariably to research and education. The medicines authority is a pioneer in encouraging its team to further their studies and research to master and doctorate levels. Professionals are performing groundbreaking research, such as in the dissertation ‘Therapeutic and Economic Implications of Regulating Stem Cell Therapy and Blood Components’. This augurs well for the authority to take up the Prime Minister’s appeal to the nation not to rely on present successes but to move forward towards innovative and challenging endeavours, such as was done in the case of blockchain and the introduction of cannabis for medicinal use.
Innovative initiatives need to be picked up in the early stages to lay a strong foundation for success to be endowed to the next generation, that is, for our children and grandchildren. These investments, which will bear fruit in the future, can only be carried out because in the last five years the government has set a strong economic and intellectual basis.
The authority is a prime example of an entity that has responded to the Prime Minister’s impetus and is moving towards becoming a sustainable and successful entity, especially through substantial investment in its team of highly committed and motivated professionals.
The assignment of the stem cell initiative to the Malta Medicines Authority, by the Secretariat for Consumer Rights, Public Cleansing and Support for the Capital City, was a move in the right direction, signalling a long but virtuous path towards innovation in advanced therapies, which is tomorrow’s science of medicine. Scientific innovation in stem cells cannot be conceived without advanced regulatory science structures and education.
This is something I have explained to the leaders of our tertiary education systems and it is good to see that there are already recommendations to the Senate of the University of Malta to move diligently but expediently in the field of the regulatory sciences.
Stem cell therapy is no longer science fiction. It is a challenge for the present and the future. Challenges present risks. The key to risk reduction in introducing stem cell therapy is the application of robust regulatory sciences.
This is what I am continuously encouraging the Malta Medicines Authority to execute, and I am fully confident that success will be achieved in this area. There are several barriers that still need to be overcome before this novel therapy can be translated from the laboratory to the clinic. But stem cell therapy has brought in optimistic hope among researchers, doctors and patients who are the chief beneficiaries of this innovation.
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