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Case Of Skin Necrosis After Exosome Injections Prompts Renewed Warnings Over Unapproved Treatments
07/05/2025 • by The RAM Institute
A published case of severe skin necrosis following the injection of an exosome-based product has reignited debate about the safety of unregulated regenerative treatments.
The incident, which occurred outside the UK, involved the use of a human cord blood-derived exosome formulation marketed for skin rejuvenation – a type of product that is not licensed for injection use in the UK.
The case, published in the Journal of Cosmetic Dermatology, described a 38-year-old man who developed ulceration and tissue death on both cheeks three days after receiving intradermal injections of a lyophilised exosome product manufactured in South Korea. Despite medical care and laser treatment, the patient was left with atrophic scarring and hyperpigmentation.
In a follow-up correspondence in the same journal, a group of dermatologists noted that while vascular injury was the most likely cause, other mechanisms such as infection, immune reaction, or mechanical vascular damage could not be ruled out. They also highlighted that products made from cord blood–conditioned media carry a risk of immune responses and, unlike dermal fillers, have no reversal agent if vascular compromise occurs.
In the United Kingdom, no exosome-based injectable product is currently authorised for medical or cosmetic use. Under UK medicines law, any product containing human-derived material – including exosomes from cord blood or stem cells – is treated as a medicinal or advanced therapy product. Such products cannot be legally injected outside a licensed clinical trial or approved therapy.
The case and commentary together highlight growing international concern about the cosmetic use of unregulated exosome injectables and the need for stricter oversight and safety testing before clinical adoption.
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