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Article History

Received: 23 April 2026

Accepted: 18 July 2026

First Online: 6 August 2026

Declarations

Ethics approval and consent to participate: The study was conducted following approval from the Hospital General Universitario Gregorio Marañón (HGUGM) ethics committee (code: TRP4-22–007) and in accordance with the principles outlined in the Declaration of Helsinki. Informed written consent from legal guardians was obtained prior to the enrolment of patients.

Consent for publication: Not applicable.

Competing interests: EBdQ, MMB, PV and MP are currently employed by THYTECH SL. EBdQ, MMB, RCR and MP are co-founders of Thytech SL. RCR also serves as President of the Board of Directors and Chief Scientific Officer (CSO) of the company. Thytech SL is a biotechnology company focused on the development of regulatory T-cell (Treg)-based cellular therapies. However, the company has no current commercial activity, development program, intellectual property strategy, or business interest related to extracellular vesicles or to the specific subject matter addressed in this manuscript. The present work was conceived and conducted independently by the authors in their capacity as academic and clinical researchers. Thytech SL had no role in the study design, funding, data collection, data analysis, interpretation of results, decision to publish, or preparation of the manuscript. No financial support, compensation, or sponsorship related to this manuscript was provided by Thytech SL. All other authors declare no competing interests.