The Belgian Federal Agency for Medicines and Health Products (AFMPS) has warned patients about unauthorized stem cell therapies offered outside the EU, particularly in Turkey, where providers promote unproven treatments for serious and chronic conditions. For physicians, the warning highlights the importance of recognizing these claims and helping patients understand the potential risks before they seek treatment abroad.

Many clinicians have already encountered this situation in practice: A patient with a severe neurologic disease, developmental disorder, or chronic disabling condition arrives with information gathered from the internet, a quote from a foreign clinic, and a simple question: “What do you think, doctor?” The AFMPS has now formally addressed a practice that can expose patients to serious risks and warrants greater awareness among healthcare professionals.

The AFMPS specifically names two Turkish facilities in its warning: Liv Hospital and You StemCell. Like other providers of this type, these facilities make extensive use of websites and social media to target patients with conditions for which conventional medicine offers limited treatment options, including autism, cerebral palsy, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, diabetes, infertility, and amyotrophic lateral sclerosis.

This list is significant because these conditions may lead patients and families to seek options when established treatments offer limited benefits. Exhausted families, patients facing a therapeutic impasse, and relatives willing to try almost anything may be particularly vulnerable. These offers target vulnerability by claiming, without a solid scientific basis, to cure diseases for which the global medical community has not yet found effective cures.

Stem Cell Therapy and Risk

For healthcare professionals, a basic refresher course is essential when patients are exposed to scientifically inaccurate information. Stem cell therapy involves the use of cells capable of differentiating into other cell types to replace damaged, diseased, or missing cells in the body. Stem cell therapy is an active and legitimate field of research that has led to important advances, particularly in hematologic malignancies, where hematopoietic stem cell transplantation is a regulated and established treatment.

The gap between this clinical reality and the treatments targeted by the AFMPS is considerable. Stem cell therapies offered outside the EU have not undergone the quality, safety, and efficacy evaluations required by the EU regulatory framework. In the EU, advanced therapy medicinal products, which include certain stem cell-based therapies, are subject to a centralized authorization procedure through the European Medicines Agency (EMA) with stringent requirements. None of the products offered by the providers identified in the warning fall within this regulatory framework.

The AFMPS is explicit: These treatments can cause serious adverse effects. Risks identified in the scientific literature associated with unauthorized therapies include severe immune reactions, infections, tumor-related complications associated with the administration of inadequately characterized cells, and neurologic complications. The products used are often difficult to trace, and the qualifications of practitioners providing the treatments may also be difficult to verify.

Therefore, additional indirect consequences should be considered. Patients who pursue these treatments may delay or stop approved care; face substantial financial costs, with some treatments costing several thousand or even tens of thousands of euros; and return with complications that require care within the Belgian healthcare system. In some cases, they may also lack adequate medical documentation of the treatment received by the patients.

Role of Healthcare Professionals

The AFMPS recommendations are primarily directed at patients but have direct implications for healthcare professionals. Patients should not be persuaded by promises of miraculous results, should approach advertisements on social media with caution, and should consult their primary care physician before committing alternative treatment. This places healthcare professionals in a strategic position.

In practice, there are several clinical situations that should raise a red flag:

• A patient or family member mentions finding or contacting a clinic abroad that offers regenerative or stem cell therapy.
• A patient asks for information about or seeks approval of stem cell treatment that has not been prescribed or authorized.
• A patient returns from treatment abroad with unexplained complications or incomplete medical documentation.

In these situations, consultation should provide an opportunity to assess what treatment the patient actually received, identify potential clinical warning signs, and refer the patient for appropriate care. Any suspected complications or adverse events can be reported to the AFMPS, which actively collaborates with other EU health authorities to identify and act against the providers involved.

The AFMPS stated that authorities were addressing these offers and cooperating with their EU counterparts. However, digital marketing channels, including social media, search engines, and wellness influencers, are evolving faster than regulatory mechanisms can keep pace. Clinics can change their names, website domains, or country of administrative residence more quickly than health authorities can initiate proceedings.

The EMA has similarly warned about unregulated advanced therapies, noting that patients may face serious adverse effects without proven benefits. The agency advises patients and caregivers to exercise caution with therapies promoted online or through social media, and to seek advice from competent national authorities before proceeding.

In this context, medical consultations remain an important safety measure. A patient who has been informed by their doctor about the actual risks and reassured that their desire to improve their well-being is heard and taken seriously may be less likely to turn to unproven treatment.

Being aware of these practices, discussing them without judgment, and offering credible alternatives may be the most concrete contributions that healthcare providers can make in response to this alert.

This story was translated from MediQuality, part of the Medscape Professional Network.