Cell therapies and Advanced Therapy Medicinal Products (ATMPs) represent one of the fastest-growing and most promising fields in modern medicine. They are based on the use of cells, genetic modifications, or combined biological products, with the aim of treating serious diseases for which, until recently, therapeutic options were severely limited.
This is the assessment of Maria Roubelaki, president of the Hellenic Society of Gene Therapy and Regenerative Medicine, speaking to the Athens-Macedonian News Agency (ANA-MPA).
Stem cells, she emphasizes, occupy a particularly important place in this field. Their unique ability to self-renew and differentiate into specialized cell types makes them a valuable tool for regenerative medicine.
Myths and facts about stem cells
“The first great truth, however, is that stem cells are not a cure-all,” Roubelaki states plainly.
“They cannot treat every disease, nor is every application marketed as ‘innovative’ safe or scientifically validated. There are proven and approved applications, such as hematopoietic stem cell transplantation, which has been used for decades to treat serious blood disorders. Alongside these, therapies such as CAR-T cell therapies are being developed, which have transformed outcomes for patients with certain forms of cancer. However, many other applications remain at the preclinical research or clinical trial stage.”
She warns that this is precisely where the greatest risk lies: “confusing approved therapies with applications that are still at the research stage — or, worse still, with interventions lacking adequate scientific evidence, carried out outside any approved institutional framework.”
Roubelaki also draws attention to the internationally documented phenomenon of unverified stem cell treatments and what is known as “stem cell tourism” — a practice where patients travel abroad to receive procedures that have not been evaluated through the necessary clinical trials and have not received approval from competent regulatory bodies such as the EMA, the FDA, or Greece’s national medicines agency (EOF).
“When a patient is facing a serious or incurable disease, it is natural to seek hope,” she says. “But that very vulnerability makes them more susceptible to promises of unvalidated treatments that frequently trade on that hope.”
Why accurate information matters
Correct information is critical, Roubelaki stresses. Patients should always ask whether a therapy is approved, for which specific indication it has been authorized, which regulatory body evaluated it, and whether an official approval number exists. They should also ensure that any treatment is administered in a certified hospital setting. Approval granted in one country under one regulatory framework does not automatically extend to treatments offered in another country without equivalent oversight, leaving the patient outside meaningful institutional protection.
Greece’s position in advanced therapies
According to Roubelaki, Greece is at a transitional but significant stage. “Public discussion about advanced therapies has now opened up at the institutional, scientific, and social level,” she notes. A recent symposium organized by the Hellenic Society of Gene Therapy and Regenerative Medicine was the first organized effort to responsibly inform the public about cell therapies.
At the legislative level, Article 32 of a bill currently under public consultation introduced discussion about the production and administration of ATMPs in Greece within the framework of the so-called “hospital exemption”, a provision that allows certain advanced therapy products to be prepared and used in a hospital setting outside the standard centralized authorization pathway.
Roubelaki explains that “the hospital exemption can be a valuable tool, but only under strict conditions. It must not function as a parallel pathway for the uncontrolled distribution of non-approved therapies. Instead, it must apply to a limited number of patients, where there is a documented therapeutic gap, with clear scientific justification, production in units complying with Good Manufacturing Practice standards, full traceability, pharmacovigilance, and long-term follow-up.”
For ATMPs administered under the hospital exemption, she stresses that the roles of bodies such as the EOF, the EOM, and the Ministry of Health must be clearly defined and decisive, covering product assessment, authorization of production and use, and systematic monitoring of safety and efficacy.
Protecting innovation through institutional safeguards
Roubelaki is clear that “the goal is not to restrict innovation, but to protect it. The development of advanced therapies requires clear rules, strict oversight, and transparency.”
Greece, she notes, has the scientific capacity, universities, research institutes, and hospital centers with experience in developing cell and gene therapies. To make the most of that potential, what is needed is a credible institutional framework, aligned with European legislation, that guarantees patient access to innovative treatments under conditions of safety, quality, and scientific evidence.
Her conclusion: “We look forward to Greece’s greater participation in the development and application of advanced therapies — on the condition that oversight mechanisms are strengthened, specialized production units are established, and collaboration between the state, the scientific community, and patient associations is deepened. Real progress will not come through exaggerated promises or so-called ‘miracle cures,’ but through evidence, accountability, and robust institutional safeguards.
