Santé : Publicité en ligne des thérapies par cellules souches : l’ANSM suspend la promotion de deux cliniques turques

Context of the decisions of July 28, 2026

These two decisions are part of an ongoing series of actions initiated by the ANSM against the online promotion of unauthorized cell therapies:

• November 27 and 28, 2024: three decisions targeting the companies Immucura, Immunyo, and Iaso Health GmbH regarding dendritic cell therapies presented as cancer treatments (with the Immunyo decision suspending activities related to the therapy, going beyond merely halting advertising);
• February 11, 2025: decision targeting Primo Medico, the fourth operator identified for the same type of therapy;
• March 14, 2025: joint statement by the EMA and the Heads of Medicines Agencies (HMA) network warning of the risks associated with unregulated advanced therapy medicinal products;
• October 17, 2025: decision targeting Linden Clinics regarding a stem cell and exosome therapy;

And finally, the two decisions of July 28, 2026.

The procedural steps were identical in both cases: the ANSM first sent a letter of intent on December 4, 2025, to each of the Turkish companies.

Following a lack of response, the ANSM issued a suspension decision on July 28, 2026, which was published on August 10, 2026 (accompanied by a patient information notice).

A three-step line of reasoning

1. Classification as a medicinal product (Article L. 5111-1 of the Public Health Code)

The ANSM proceeds along two lines of inquiry, which are worth noting:

• Medicinal product by presentation: the websites claim to treat serious conditions—such as autism, cerebral palsy, multiple sclerosis, Alzheimer’s, Parkinson’s, ALS, diabetes, and infertility—citing specific success rates and promising improvement. For instance, You StemCell presents stem cells as “innate healers,” while Liv Hospital promises the “regeneration of nerve cells.”
• Medicinal product by function: the Agency notes that the claimed anti-inflammatory and immunomodulatory properties characterize a significant pharmacological and immunological action intended to restore physiological function in the recipient. The ANSM also relies on the described preparation methods (mesenchymal cells derived from adipose tissue or bone marrow, or fetal cells from a donor) and cites—in the case of You StemCell—the lack of information regarding the processing, preparation, and storage of the harvested cells.
  It should be noted that the exosomes added by Liv Hospital for two indications (diabetes and multiple sclerosis) are expressly classified as biological medicinal products.

2. Absence of any authorization (Article L. 5121-8 of the Public Health Code)

The ANSM finds that none of the therapies in question has received national or centralized marketing authorization, nor any derogation-based authorization under Articles L. 5121-12 (early access), L. 5121-12-1 (compassionate access), or L. 5124-13 (parallel import) of the Public Health Code; consequently, no assessment of quality or the benefit-risk ratio has been conducted.

3. Classification as advertising and territorial nexus

This is the core contribution of these decisions. The Agency holds that the websites promote the use of these therapies to the general public and healthcare professionals by highlighting the availability of specialized physicians and inviting patients to contact the clinic. It concludes that these sites are likely to encourage patients to travel to another country to receive the treatment and, on that basis alone, meet the definition of advertising for a medicinal product within the meaning of Article L. 5122-1 of the Public Health Code (CSP).

However, only medicinal products holding a marketing authorization (MA) may be advertised (Art. L. 5122-3 CSP); such advertising is also subject to prior approval by the ANSM (Art. L. 5122-8 and L. 5122-9 CSP)—an approval these companies did not possess.

Effectiveness of the measure and subsequent actions

For companies with no establishment in France, the suspension relies largely on its publication and on informing patients. Beyond that, the available enforcement arsenal is substantial:

• criminally, any advertising continued despite the suspension is punishable by one year of imprisonment and a fine of €150,000 (Art. L. 5422-6 CSP);
• financially, the violations referred to in Article L. 5422-18 CSP may result in a sanction imposed by the ANSM of up to 50% of the revenue generated from the product concerned—capped at five million euros for a legal entity—potentially accompanied by a daily penalty payment of €2,500 and a ban on the advertising in question (Art. L. 5471-1 CSP);
• The ANSM could—as it did in the case of dendritic cell therapies—reserve the right to refer the matter to the public prosecutor and submit a report via the official platform for reporting illegal online content (PHAROS).