When activated, platelets release extracellular vesicles. Platelet-rich plasma therefore contains a heterogeneous population of extracellular particles in addition to soluble proteins, cytokines and other blood components. Their amount and composition depend, among other things, on blood collection, anticoagulant, time to processing, temperature, centrifugation and activation conditions.

This does not mean that “PRP” and “isolated PRP-EV” are interchangeable. Once a vesicle fraction is deliberately separated, concentrated, purified or formulated, its composition, dose definition, quality control and potentially its regulatory status change. Results obtained with conventional PRP therefore do not prove efficacy of an EV concentrate – and vice versa.

Clinical development has begun, but it is much less advanced than many marketing texts suggest. The crucial distinction is between platelet-derived EV in general and EV obtained specifically from PRP.

In 2023, a randomised, double-blind, placebo-controlled phase I study of allogeneic EV obtained from activated platelets was published. Its primary focus was safety and tolerability in healthy adults. Treatment at the single dose studied was well tolerated; wound-closure time did not differ between treated and untreated wounds. This is an important human safety dataset, but not evidence of clinical efficacy. [2]

What is currently happening clinically with “PRP-derived EV”

Clinical programmes for PRP-derived “exosomes” are now registered. One example is NCT07124871, a single-arm feasibility study in erectile dysfunction; the registry entry currently reports no results. A trial registry demonstrates development activity, but it replaces neither a publication nor evidence of efficacy. [16]

A 2026 study of diabetic foot ulcers is also important for context: the patients were treated with PRP; isolated PRP-EV were analysed to correlate microRNA signatures with healing outcomes. This is biomarker/mechanistic research within PRP treatment – not an EV therapy study. [17]

PRP and medicinal-product law

The German Medicinal Products Act defines blood preparations as medicinal products consisting of or containing blood, plasma or serum preparations obtained from blood, blood components, or preparations made from blood components. [7] Whether a specific PRP procedure and its manufacture require an authorisation or notification depends on the setting and the statutory exemptions. Section 13 AMG includes, among other things, an exemption for patient-specific manufacture under the direct professional responsibility of a person authorised to practise medicine. [8]

In 2024, the Bavarian Higher Administrative Court ruled in proceedings concerning non-medical practitioners that the PRP plasma autologous-blood therapy described in that case also falls under the physician reservation in Section 7(2) TFG. The judgment is important, but should not be detached from its specific facts and presented as a blanket statement about every physician-led PRP procedure. [10]

What changes with an isolated EV fraction?

A more extensively processed vesicle fraction must be assessed separately from a regulatory perspective. For finished medicinal products, Section 21 AMG generally governs authorisation before placing on the market and also contains statutory exemptions. [9] It would therefore be too broad to say that “EV isolation automatically always leads to a particular authorisation requirement”. Product type, extent of manufacture, autologous/allogeneic origin, supply/placing on the market, modification and intended purpose must be assessed case by case.

ATMP: neither a blanket yes nor a blanket no

The regulatory discussion changed in 2025/2026. The current EMA guideline on investigational ATMPs has applied since 1 July 2025. A regulatory analysis published in 2026 places non-substantially modified, cell-derived EV outside the current ATMP definition; more extensively modified or loaded EV may be assessed differently depending on the product concept. [4][5] For shop or practice content, the safer formulation is therefore: Assess ATMP status product by product; do not infer it from the word “exosome”.

Regulatory framework provided as specialist editorial orientation only; specific products/manufacturing processes require case-by-case assessment. [3][4][6][7–10]

On a commercial website, it is not enough for individual sentences to be softened with words such as “may” or “possibly”. The overall impression is decisive. Section 3 HWG prohibits misleading advertising, in particular where therapeutic effects are attributed without adequate evidence. Section 3a HWG prohibits advertising for medicinal products that require authorisation but are not authorised. [11]

For this topic, mechanisms, animal models, human safety data and clinical efficacy should remain strictly separated in the wording. A disclaimer at the end cannot neutralise an earlier excessive healing or superiority claim.

Platelet-derived and PRP-derived extracellular vesicles are a relevant research field within PRP biology. The data now extend beyond cell and animal models: a controlled phase I study in humans exists for one specific allogeneic platelet-derived-EV preparation. It provides safety data, but no evidence of clinical superiority or of a therapeutic effect in a disease.

For practice and product communication, a clear line therefore remains appropriate: name the cell source, do not generalise the preparation or manufacturing process, characterise in line with MISEV, make the evidence level visible and make regulatory statements only in relation to a specific product. “Exosome” may be used as a search term – it is not suitable as a blanket promise of quality or efficacy.