PRP

EXO-COMPLICATIONS

Regenerative expert and nurse Claudia McGloin investigates the complications involved with human-derived exosomes

CLAUDIA MCGLOIN

Claudia McGloin is a registered nurse and holds dual registration in both the UK and Ireland. With more than 27 years’ nursing experience, McGloin is the clinical director and nurse practitioner at The New You Clinic in Sligo. She is one of Ireland’s leading platelet-rich plasma experts and has performed thousands of PRP treatments. She has shared her expertise on the international stage and in various publications.

Exosome-based therapies have emerged as an exciting frontier in aesthetic dermatology, often marketed for their regenerative potential in skin rejuvenation and repair. Human-derived exosome products are not licensed for clinical use in the UK, due to the lack of large-scale safety data and formal approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for aesthetic applications.

CASE STUDY: COSMETIC SKIN REJUVENATION USING EXOSOME INJECTIONS

A recent case series from South Korea provides insight into potential complications associated with human-derived exosome treatments. The study included eight female patients, aged 26 to 52, who underwent cosmetic skin rejuvenation using exosome injections.

Each patient developed inflammatory skin reactions, presenting as firm, erythematous papules or nodules at the injection sites. The lesions appeared within a variable timeframe, ranging from two weeks to three months after the procedure.

Biopsies were performed to find the underlying pathology, revealing necrotising granulomatous inflammation.

There was no evidence of infection or mycobacterial involvement, suggesting that the reactions were immune-mediated and directly associated with the exosomes.

Treatment responses in the series were variable. Patients received topical or systemic corticosteroids to manage the inflammation, but resolution was incomplete in several cases.

The study highlighted that even biologically derived exosomes, which are often perceived as safe due to their human origin, can provoke significant immune responses, particularly when preparation methods, product purity, and administration techniques vary.

The findings emphasise the need for a standardised manufacturing processes, rigorous quality control, careful patient selection and comprehensive informed consent.

They also emphasise the need for post-treatment monitoring to improve understanding and management of complications.

COMPLICATIONS IN HUMAN-DERIVED EXOSOMES

Exosome products can differ widely depending on the source tissue, isolation and purification protocols, storage conditions, and formulation methods.

Variability can influence the presence of residual cellular debris or immunogenic molecules, which may trigger inflammatory responses. The precise immunologic mechanisms underlying granulomatous reactions remain unclear, but delayed-type hypersensitivity to exosomal proteins or contaminants is a likely contributor. These findings illustrate that even human-derived, minimally manipulated biological products are not entirely risk-free.

BALANCING INNOVATION WITH SAFETY

The cases underscore the broader issue of regulatory oversight. In many countries, exosome products are marketed as cosmetic serums or injectables without standardised manufacturing protocols or rigorous clinical testing.

In the UK, they are not licensed for clinical use, and their administration outside regulated clinical trials would constitute an unapproved therapy. This regulatory gap has significant implications for patient safety, particularly given the potential for delayed immune-mediated complications.

Clinicians considering any form of experimental biologic therapy must exercise caution, ensure rigorous quality control, and provide thorough informed consent detailing the experimental status of the treatment and the possibility of adverse reactions.

CLINICAL PERSPECTIVE

Vigilance is essential, early recognition of papular or nodular lesions allows timely biopsy and initiation of anti-inflammatory therapy, potentially limiting complications.

Patient selection is crucial- those with autoimmune conditions, prior hypersensitivity reactions, or other predisposing factors may be at higher risk of adverse immune responses.

In addition, clinicians should document and report any adverse events to support pharmacovigilance and help guide the development of future safety standards.

THE FUTURE OF HUMAN-DERIVED EXOSOMES

Despite these concerns, exosome therapies continue to hold promise for aesthetic medicine. They can promote wound healing, stimulate collagen synthesis, and enhance tissue regeneration, making them attractive adjuncts to minimally invasive dermatologic procedures.

Practitioners must prioritise patient safety, adhere to regulated therapies, and ensure that any experimental treatments are clearly communicated as such, including potential risks of delayed inflammatory reactions.

There are plant and animal exosomes available in the UK that hold the CE mark and have some clinical data and case studies available.