Melbourne clinic says exosome therapy oversight lags
Patient demand for exosome therapy is moving ahead of regulatory oversight and sourcing standards, according to Melbourne practice Dr Tass Cosmetic and Skin Clinics.
Dr Tass Cosmetic and Skin Clinics is a cosmetic medicine practice that has operated since 2009. The clinic says it has more than 17 years of clinical experience and has performed more than 60,000 procedures.
Exosomes are nano-sized vesicles released by cells in the body. In aesthetic medicine, they are used to support skin repair, collagen production and hair follicle restoration.
The clinic said the evidence base is real but still early. Peer-reviewed studies have shown improvements in skin tone, pore size, pigmentation and hair density under controlled conditions.
A 2023 systematic review in the Journal of Cosmetic Dermatology found preliminary evidence for exosome treatment in hair restoration. However, the review also flagged the need for larger-scale trials.
Another study, a 12-week randomised split-face trial, found significantly greater improvement in acne scars when adipose tissue stem cell-derived exosomes were used after fractional CO2 laser treatment, compared with a control gel.
Dr Tass Tasiopoulos, founder of Dr Tass Cosmetic and Skin Clinics, said the key issue was not only whether exosomes work, but what is in the product, where donor tissue came from, what testing it underwent and whether the application method is on-label.
“Those questions have very different answers depending on where the product was sourced, and most patients have no way of knowing which answer applies to what they have been given,” Tasiopoulos said.
Quality testing and off-label injections
The clinic drew a distinction between exosome therapy used in a clinical setting with a properly manufactured, quality-tested product and products patients source themselves or receive from providers outside a regulated supply chain.
Exosome preparations vary widely in source, concentration, manufacturing process and donor screening standards. Properly manufactured products should include donor eligibility testing, virus screening, sterility testing, mycoplasma testing and quantification from cell collection to final product.
According to the clinic, many online or unvetted products do not include that documentation at all. It also raised concern about patients arriving after being injected elsewhere with unidentified products and no suitability assessment by the provider.
Intradermal injection of exosome products is off-label, the clinic said, because most are formulated and tested for topical application. Patients offered injections are receiving a treatment the manufacturer does not sanction.
Dr Tass Cosmetic and Skin Clinics said it uses exosome therapy clinically with documented quality controls after individual patient assessment. The practice operates across Crown Spa Melbourne, Port Melbourne and Ripponlea.
