Autologous versus Non-autologous Exosomes: Immunological, Safety, and Regulatory Considerations in Regenerative Medicine
Original Article | Vol 5 | Issue 1 | January-June 2025 | page: 31-33 | Ivanny Marchant, Belén Rodríguez, Valentina Pozo, Leopoldo Parada, Carla Salvo, Pablo Olivero
DOI: https://doi.org/10.13107/jrs.2025.v05.i01.167
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 16 Mar 2025, Review Date: 20 May 2025, Accepted Date: May 2025 & Published: 30 Jun 2025
Author: Ivanny Marchant [1], Belén Rodríguez [1], Valentina Pozo [1], Leopoldo Parada [2], Carla Salvo [3], Pablo Olivero [1]
[1] Unidad de Estudios Clínicos, Escuela de Medicina, Universidad de Valparaíso, Chile,
[2] Centro de Medicina Regenerativa CITOMED, Viña del Mar, Chile,
[3] Centro de Sangre y Tejidos de Valparaíso, Chile.
Address of Correspondence
Dr. Pablo Olivero,
Unidad de Estudios Clínicos, Escuela de Medicina, Universidad de Valparaíso, Chile.
E-mail: pablo.olivero@uv.cl
Abstract
Small extracellular vesicles (sEVs), commonly referred to as exosomes, have emerged as novel therapeutic tools in regenerative and esthetic medicine. A critical decision in their clinical application is the choice between autologous and non-autologous products, as this distinction directly impacts safety, immunocompatibility, efficacy, and regulatory compliance. This review analyzes the immunological profile and biological risks associated with exosomes’ clinical use according to their cellular origin, addressing persistence, pathogen transmission, delivery routes, and regulatory classification. Furthermore, we highlight the strategic role of blood centers and biobanks in producing high-safety allogeneic sEVs, especially those derived from human platelets and mesenchymal stromal cells expanded in xenofree conditions. While autologous exosomes offer maximal immunological safety, standardized allogeneic strategies free from animal-derived components represent a scalable and regulatory-compatible alternative for modern regenerative therapies.
Keywords: Exosomes, Regenerative Medicine, Autologous Exosomes, Non-autologous Exosomes
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| How to Cite this article: Marchant I, Rodríguez B, Pozo V, Parada L, Salvo C, Olivero P | Autologous versus Non-autologous Exosomes: Immunological, Safety, and Regulatory Considerations in Regenerative Medicine | Journal of Regenerative Science | Jan-Jun 2025; 5(1): 31-33.
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