Regenerative Medicine is a modern field of biomedicine that aims to repair, replace or regenerate cells and tissues, utilizing cellular and gene approaches, tissue engineering and biomaterials. It should not, however, be confused with wellness, anti-aging or aesthetic practices that use the term "regenerative" without the corresponding scientific and regulatory documentation.
The word 'stem cells' and/or 'regenerative' in an advertisement does not, in any way, constitute evidence of therapeutic efficacy. A treatment described as "cellular", "stem cell", "gene" or "regenerative" is not automatically approved, safe or effective.
At the same time, however, it is obvious: There are very few patients and citizens of our country who know that Regenerative Medicine is an officially recognized field of biomedicine, with paid faculty positions, at least at the Medical School of the University of Athens.
Even after the tragic and untimely death of the much-loved singer, Giorgos Mazonakis, the majority of the general population of our country certainly considers, among other things, as Regenerative Medicine the so-called treatments outside and beyond Medicine and Biomedicine, which were offered by the two doctors of the co-located clinic at 11 Karneadou Street, in Kolonaki, where Giorgos Mazonakis breathed his last on Wednesday, September 9, at the age of just 54.
New and evolving field
According to what Professor of Biology and Applications of Regenerative Medicine at the Medical School of the University of Athens, Maria (Maya) Roubelaki, president of the Hellenic Society of Gene Therapy and Regenerative Medicine (EEGTHAI), explains today to iefimerida, "Regenerative Medicine is a relatively new and rapidly evolving field of modern Medicine and biomedical research. Its development is linked to the great progress that has been made in recent decades in cell and molecular biology, stem cell biology, gene therapy, tissue engineering and biomaterials."
In fact, she adds: "Because it is a newer and highly specialized field, Regenerative Medicine has not yet been fully understood by the general public. At the same time, the term "regenerative" is increasingly used in public debate, advertising and social media, not always in its true scientific sense. This creates confusion and can even lead to misleading use of scientific terminology."
As Maria (Maya) Roubelaki states, "the goal of Regenerative Medicine is the repair, restoration, replacement or regeneration of cells and tissues that have suffered damage or dysfunction, with the ultimate goal of restoring their function. For this purpose, it can utilize cellular and gene approaches, primordial cells, tissue engineering techniques, biomaterials or combinations of these. Simply put, regeneration does not generally mean 'rejuvenation'. It means trying to repair a real biological and functional damage."
It is worth noting that the field of Regenerative Medicine also includes Advanced Therapies. According to the European Medicines Agency (EMA), Advanced Therapy Medicinal Products (ATMPs) include gene therapies, somatic cell therapies and tissue engineering products. These are approved complex therapeutic approaches that are subject to strict requirements in terms of their production, quality, safety and efficacy.
The basic and most common misconception
Maria (Maya) Roubelaki also explains something that is very important as well as very useful for all of us to know, not only patients, but all citizens and residents of our country:
"The critical thing for the public is that a treatment is not approved or scientifically documented simply because it is labeled 'cellular', 'genic' or 'regenerative'. Approved advanced therapies are governed by a clear and strict legal and regulatory framework and are administered in a controlled medical environment, in specialized and appropriately licensed hospital centers, by specially trained doctors, for specific therapeutic indications and with the prescribed medical supervision. Where a therapeutic approach is still in the research stage, it must be implemented in an approved clinical trial, with a specific protocol, approval by the competent authorities and systematic monitoring of its safety and efficacy."
This is exactly where the basic misconception lies. Terms such as "cell therapy," "gene therapy," "stem cell or stem cell therapy," or "regenerative therapy" may create the impression that an intervention is automatically safe and effective.
It is well known and self-evident, in fact, that cassocks do not make a priest. In other words, it is not the name that certifies a treatment, but the scientific documentation, its approval for the specific use and the context in which it is applied.
Maria (Maya) Roubalaki is categorical as well as clear: "Regenerative Medicine should not be confused with Wellness Medicine nor with practices of "rejuvenation", anti-aging or general enhancement of the well-being of healthy people. The distinction is not just serological. It is a matter of scientific documentation, medical ethics, transparency and, above all, the safety of citizens. Confusion can have real consequences: economic exploitation, exposure to unknown risks, or even delaying an appropriate treatment."
Therefore, before any "regenerative" or advanced treatment, the citizen should ask: Is it approved? By which competent authority? For which specific condition? Where does it take place? Are there clinical data? Is this an approved treatment or an approved clinical trial?
Finally, the professor notes: "Proper information does not limit innovation. On the contrary, it protects the patient and the public and at the same time protects scientific progress itself from misinformation and the misuse of scientific terminology."
Before accepting any "advanced" and/or cellular therapy, ask:
For what exact condition is it recommended?
Is it specific to this condition or for many?
Which competent authority has approved it? Ask for a product/treatment name and approval details.
What are the documented benefits and risks?
If experimental: is it part of a legally approved clinical trial or other approved therapeutic approach (e.g., hospital exemption)?
Are there published clinical data in humans for this indication?
Which doctor takes responsibility and where will the treatment and monitoring take place?
Are there other treatment options for your case?
Seek a second independent medical opinion before deciding.
Great caution is needed
Which competent authority has approved it? Ask for a product/treatment name and approval details.
What are the documented benefits and risks?
If experimental: is it part of a legally approved clinical trial or other approved therapeutic approach (e.g., hospital exemption)?
Are there published clinical data in humans for this indication?
Which doctor takes responsibility and where will the treatment and monitoring take place?
Are there other treatment options for your case?
Seek a second independent medical opinion before deciding.
Great caution is needed
The European Medicines Agency (EMA) has repeatedly warned that unregulated and unproven cell therapies may not be safe or effective. Serious, even fatal, side effects have been reported, such as infections, immune reactions, tumour formation, vision loss, and cerebral haemorrhage.
Treatments without a marketing authorisation are legally administered, exclusively in the context of properly designed clinical trials or hospital exemptions, which are supervised and assess safety and benefit for patients.
Because, in the end, hope needs scientific documentation.
iefimerida.gr
Treatments without a marketing authorisation are legally administered, exclusively in the context of properly designed clinical trials or hospital exemptions, which are supervised and assess safety and benefit for patients.
Because, in the end, hope needs scientific documentation.
iefimerida.gr
