Scope of this article
This content is not diagnosis, prescribing, personal risk assessment or a treatment plan. Sources may be limited to a particular product, device, task, indication or study group.
This translation is provided for general access and has no recorded medical-language review.
Editorial general information — not a clinical-review record
Published: Updated: Publisher: Dr. Murat Toktamışoğlu
Exosomes are not cells; they describe a non-replicating subtype of extracellular vesicle released by cells. Stem-cell-derived, conditioned medium, secretome, cell lysate and purified extracellular vesicles do not describe the same product. Composition and regulatory status cannot be inferred from a marketing label.
This translation has no recorded clinical or medical-language review.
MISEV2023 favours operational terms such as small extracellular vesicles when cellular origin has not been demonstrated. Exosome refers to vesicles formed through an endosomal pathway inside cells. Particle size or a few surface markers alone cannot show that every particle in a preparation is an exosome; proteins, lipoproteins and other extracellular particles may coexist.
A vial may contain purified vesicles, conditioned culture medium, plant-derived particles, synthetic liposomes or mixtures with carriers. If donor and cell source, manufacture, separation, characterization, sterility, endotoxin, storage and batch acceptance are not documented, a stem-cell technology phrase does not supply the missing information.
Laboratory identity and clinical safety or effectiveness are different questions. Look for human evidence involving the exact source, product, route, dose, comparator and follow-up. FDA's statement that no exosome product is approved in the United States does not determine status in every country; classification and permission in Türkiye require separate official verification.
This content is not diagnosis, prescribing, personal risk assessment or a treatment plan. Sources may be limited to a particular product, device, task, indication or study group.
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Foppiani JA et al. · 2025
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
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Austin GK, Struble SL, Quatela VC · 2022
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
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Sanyal RD, Fabi SG · 2024
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U.S. Food and Drug Administration (FDA) · 2025
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
Editorial source — not a signed clinical review
Pour Mohammad A et al. · 2023
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Mirza HN, Mirza FN, Khatri KA · 2021
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
Editorial source — not a signed clinical review
U.S. Food and Drug Administration (FDA) · 2023
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
Editorial source — not a signed clinical review
International Society for Extracellular Vesicles consensus authors · 2024
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U.S. Food and Drug Administration (FDA) · 2019
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J. C. Flores Rodríguez et al. · 2026
Scope and limitations: Interpret this source only within the exact product, device, method, indication and study population it names. It does not establish personal suitability, Turkish authorization, a universal protocol or a guaranteed outcome; consult the full source and current local information.
Editorial source — not a signed clinical review