Under the FDA position, injected or intravenous use of exosome material in people in the United States belongs inside clinical trials conducted under an FDA Investigational New Drug application, and the agency states that there are currently no FDA-approved exosome products [1, 3]. The controlled facial studies used topical application after a laser or microneedling pass, a published saline-controlled hair pilot used intradermal scalp injection outside the United States, and the serious adverse events reported in the literature, including tissue necrosis and persistent granulomas, followed injection outside any study [6, 7, 8, 9, 10, 22].
Patients comparing injection with topical application, and the practices that answer them, usually begin with the FDA notice and then ask what followed injection and where injected use is studied lawfully. The sections below take those questions in turn, add the FDA microneedling page, and close with what the controlled topical studies measured; every clinical decision belongs to the licensed practitioner.
Supplier position
The FDA stated in 2019 that there are currently no FDA-approved exosome products, and its 2021 patient information page states that the agency has repeatedly notified clinics of the need for an Investigational New Drug application before these products are given to patients [1, 3]. ExaVeyra Sciences supplies exosome material for topical aesthetic use by licensed practitioners, and for laboratory research and clinical research conducted under an IND, described by its available formats. The practitioner decides use, and ExaVeyra makes no statement about route or outcome.
Understanding the FDA notification and the Nebraska adverse events
The FDA issued its public safety notification on exosome products in December 2019 after multiple reports of serious adverse events in patients in Nebraska who received unapproved products marketed as containing exosomes, reports that reached the agency through the Centers for Disease Control and Prevention and the Nebraska Department of Health and Human Services [1]. The notification states that there are currently no FDA-approved exosome products and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products [1].
The notification gives patients a specific question to ask: whether the FDA has reviewed what is offered, and, for a study, the FDA-issued IND number and the agency letter acknowledging it [1]. The 2020 consumer alert, current as of April 2024, adds that exosome products intended for diseases or conditions require FDA approval as a general matter and points patients and practitioners to MedWatch [2, 21].
The agency’s 2021 patient information page is the most direct of the three. It states that the FDA has repeatedly notified manufacturers, clinics and practitioners of the need for Investigational New Drug applications before these products are given to patients, that a listing on clinicaltrials.gov or a firm’s registration with the FDA does not mean a product is legally marketed, and that a product offered outside a clinical trial under FDA oversight is likely offered illegally [3].
The FDA places injected and intravenous use inside trials under an IND
Under FDA rules, the IND is the mechanism that makes an injected or intravenous study lawful. The FDA explains that federal law requires a drug to be the subject of an approved marketing application before it crosses state lines, and that the IND is the means by which a sponsor obtains an exemption so that an investigational product can be shipped to clinical investigators [4]. An Investigator IND is submitted by a physician who both initiates and conducts the study [4].
| Registry entry | Design | Route studied | Status at audit | FDA-regulated drug flag |
|---|---|---|---|---|
| NCT04493242 (Lightner 2023) [13, 14] | Phase 2, randomized, placebo controlled, 102 adults, five US sites | Intravenous infusion | Completed; results posted | Yes |
| NCT06918808 [15] | Phase 2, randomized, placebo controlled, 36 estimated, US sites including an academic medical center | Injection of a frozen MSC secretome and vesicle product | Recruiting (start May 2025) | Yes |
| NCT06429033 [16] | Phase 1 safety study, 8 participants, California | Injection into the abdominal hypodermis | Completed; no results posted | Yes |
| NCT06930326 [17] | Randomized, saline controlled, 24 participants, Malaysia | Intradermal scalp injection | Completed; no registry results, results appear published as Amini 2025 [22] | No (outside US oversight) |
Lightner and colleagues reported the largest of these in 2023: a phase 2, double-blind, randomized, placebo-controlled trial at five US sites in which 102 adults with COVID-19-associated respiratory failure received placebo or intravenous infusions of a bone marrow MSC-derived vesicle product on days 1 and 4 [13]. The authors reported no treatment-related adverse events, a primary mortality outcome that did not reach significance, and several authors employed by the sponsor [13, 14].
The same pattern holds at the small end. An eight-person phase 1 study of an exosome product injected into the abdominal hypodermis in California was registered as an FDA-regulated drug study [16]. In the United States, the phrase "exosome IV therapy" that people search for describes the setting of registered trials like these, which is where the FDA places such use [3, 4].
Case reports after injection describe necrosis and persistent granulomas
Wang, Bajwa and Rivers mapped 17 human studies of exosome products in dermatology from 2020 to 2025 and reported that adverse events were uncommon, and that the ones recorded, granulomas, necrosis and allergic reactions, followed injection [6]. The routes in those studies were topical application, microneedling, fractional CO2 laser, or injection [6].
Park KY described four women in 2025 with persistent erythema, nodules, granulomatous inflammation and scarring after intradermal injection of exosome-containing cosmetic products that had been sold for topical use, given in nonclinical settings [7]. AlBargawi described one man the same year with tissue necrosis of both cheeks three days after multiple dermal injections of a freeze-dried exosome product [8].
Both reports concern products used by a route their labeling did not describe and outside any registered study, which is the situation the FDA patient page warns about [3, 7, 8]. The "exosome injection side effects" a searcher finds in the literature are therefore reports from this setting, and the registered intravenous trial reported none related to the product [13].
Controlled topical studies applied material after a laser or microneedling pass
The controlled facial evidence is topical, while the published saline-controlled hair pilot injected the material [22]. Kwon and colleagues ran a double-blind, randomized, split-face trial in 25 adults in 2020, applying an adipose stem cell-derived exosome gel after each of three fractional CO2 laser sessions, and reported greater improvement with milder erythema and shorter downtime on the exosome side; the gels came from their manufacturer [9].
Park GH and colleagues randomized 28 adults in 2023 to an exosome solution or saline on opposite sides of the face after each of three microneedling sessions, and reported higher aesthetic improvement scores and instrument-measured gains in wrinkles, elasticity, hydration and pigmentation on the exosome side, with no serious adverse events [10]. Chandran and colleagues ran a phase 1 study in 2025 in which 10 healthy volunteers applied an MSC exosome ointment to the forearm three times a day for 20 days, with no product-related adverse events and no application-site reactions [11].
Gaebe and colleagues reviewed 16 facial studies with 503 participants in 2026 and reported no serious adverse events, certainty rated low or very low, and a safety signal they described as short term [12]. As those reviews describe it, the topical evidence is small, controlled, consistent in direction, and early [6, 12].
The controlled facial studies are topical, the serious adverse events reported followed injection outside a study, and the FDA places injected and intravenous use inside trials under an IND.
Understanding what the evidence does not yet show
The literature on route is clear about its own limits. The points below set out what has not been measured, and each is a reason the registered trials matter.
- No head-to-head trial compares injected with topical exosome material in the same participants; the two routes appear in different studies with different products [6, 18].
- The injected case reports involve products of unknown composition used outside their labeling, so they describe a setting and leave the material uncharacterized [7, 8].
- The registered intravenous trial studied a respiratory condition in hospital, and its findings say nothing about injection in aesthetic practice [13].
- Topical penetration is unquantified: the controlled studies measured appearance outcomes, and none measured how much vesicle material crossed the skin after a device pass [9, 10].
- Follow-up is short: 12 weeks in the split-face trials and 20 days in the phase 1 study, against months in the case reports [7, 9, 10, 11].
- Certainty is low: Gaebe 2026 rated the facial evidence low or very low with risk of bias moderate to critical [12].
- Industry ties are common: the gels in Kwon 2020 came from their manufacturer, four Chandran 2025 authors work for the developer, and Lightner 2023 was sponsored by the manufacturer [9, 11, 13].
Microneedling devices carry their own authorization limits
Topical application after microneedling is the sequence in Park GH 2023 and in most of the hair studies, and the device has a defined status. The FDA has authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in adults aged 22 or older, and its microneedling page states that the devices are not approved for delivery of cosmetics, topical medications, drugs or blood products into the skin [5].
The same page says the risks of combining the devices with other products are not known, advises patients to choose a trained provider, and advises asking whether a new cartridge is used for each patient [5]. Soltani-Arabshahi and colleagues described three women in 2014 with facial granulomas after microneedling with a topical serum and concluded that a product applied with the device can carry immunogenic particles into the dermis; no exosome product was involved [19].
A practice that applies topical exosome material after a device therefore works with two documents: the device’s authorization and the material’s labeling and lot record. ExaVeyra supplies exosome material for topical aesthetic use by licensed practitioners, with the lot number on every vial and a certificate of analysis for every lot.
Published delivery routes range from topical application to intradermal injection
Schaffer and colleagues mapped 16 studies from 2018 to 2023 and listed four routes: intradermal needle injection, microneedle patches, topical application, and topical application after an assistive device [18]. Wang 2026 found the same spread across dermatology, with topical, microneedling, fractional laser and injection routes among 17 human studies [6].
- Topical application to intact skin: the route in the phase 1 forearm study, with no application-site reactions in 10 volunteers [11].
- Topical application after a laser or microneedling pass: the route in both split-face trials and in the open-label hair studies [9, 10, 18].
- Microneedle patches: a laboratory and preclinical route in the hair literature, without controlled human data [18].
- Intradermal or subcutaneous injection: studied in registered trials in the United States and abroad and in a published saline-controlled hair pilot in Malaysia, and the route in the published case reports of harm outside a study [7, 8, 16, 17, 22].
- Intravenous infusion: studied in a registered, FDA-regulated phase 2 trial of 102 adults in hospital [13, 14].
A sponsor that studies any of these routes characterizes its material against the MISEV2023 headings for source, separation, particle size and concentration, marker proteins and morphology, and a practice can read a lot’s certificate of analysis against the same headings [20]. The route question and the documentation question are answered together.
Documented topical supply and the IND route forward
The two lawful settings for exosome material in the United States each have a paper trail: topical aesthetic use by a licensed practitioner with the lot documented, and clinical research under an IND with the material characterized for the sponsor. ExaVeyra Sciences supplies for both, with the lot number on every vial, a certificate of analysis with serology for every lot, and the characterization panel and cold-chain records available on request.
Anyone may ask our scientific team a question or apply without an NPI, and NPI verification, completed in one to three business days, gives access to the practitioner portal, product documentation and pricing. Orders ship overnight frozen on dry ice and arrive in one to three business days, and a study team planning an IND submission can request the characterization data it needs at the start, so the route forward for both settings begins with documented material.
Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
References
- 1.U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019 (content current as of 12/06/2019; verified 4 November 2026). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-productsAgency safety notification (CBER). Carries in this article: the report of multiple serious adverse events in patients in Nebraska who received unapproved products marketed as containing exosomes, the statement that there are currently no FDA-approved exosome products, the statement that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, and the advice that a patient may ask a clinical investigator for the FDA-issued IND number and the agency letter acknowledging it.
- 2.U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. Issued July 22, 2020; content current as of 04/09/2024; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomesAgency consumer alert (CBER). Carries in this article: the FDA has authority over exosome products, exosome products intended to treat diseases or conditions in humans require FDA approval as a general matter, there are currently no FDA-approved exosome products, and adverse events can be reported through MedWatch.
- 3.U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. June 3, 2021; content current as of 04/08/2024; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapiesAgency patient information page (CBER). Carries in this article: the FDA states it has repeatedly notified manufacturers, clinics and practitioners of the need for Investigational New Drug applications before these products are given to patients, that a listing on clinicaltrials.gov or a firm’s registration with the FDA does not mean a product is legally marketed, that products offered outside a clinical trial under FDA oversight are likely offered illegally, and the agency’s list of reported harms including infections and unwanted inflammatory responses.
- 4.U.S. Food and Drug Administration. Investigational New Drug (IND) Application. Content current as of 09/16/2026; verified 4 November 2026. https://www.fda.gov/drugs/types-applications/investigational-new-drug-application-indAgency explainer page (CDER). Carries in this article: federal law requires a drug to be the subject of an approved marketing application before it is transported across state lines, the IND is the means by which a sponsor obtains an exemption so that an investigational product can be shipped to clinical investigators, and an Investigator IND is submitted by a physician who both initiates and conducts the study.
- 5.U.S. Food and Drug Administration. Microneedling Devices. Content current as of 10/15/2025; verified 4 November 2026. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devicesAgency device information page (CDRH). Carries in this article: the FDA has authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in adults aged 22 or older, the devices are not approved for delivery of cosmetics, topical medications, drugs or blood products into the skin, the risks of combining the devices with other products are not known, and the agency advises patients to choose a trained provider and to ask whether a new cartridge is used for each patient.
- 6.Wang OJE, Bajwa BB, Rivers JK. Exosome-Based Therapies in Dermatology: A Scoping Review. J Drugs Dermatol. 2026;25(4):368-376. PMID 41931695. doi:10.36849/jdd.9610Scoping review (PRISMA-ScR) of MEDLINE, Embase, CENTRAL, PubMed, US and EU trial registries and grey literature; 17 human studies from 2020 to 2025. Carries in this article: the delivery routes in the human studies (topical application, microneedling, fractional CO2 laser, or injection), 76 percent of studies recording improvement in a skin outcome, and adverse events that were uncommon but included granulomas, necrosis and allergic reactions after injection. Disclosure: no COI statement in the PubMed record.
- 7.Park KY. Adverse Reactions Following Intradermal Injection of Exosome-Based Formulations: A Case Series. J Cosmet Dermatol. 2025;24(10):e70520. PMID 41097876. PMC12528963. doi:10.1111/jocd.70520Case series (South Korea); four adult women after intradermal injection of exosome-containing cosmetic products sold for topical use, given in nonclinical settings. Carries in this article: persistent erythema, nodules, granulomatous inflammation and scarring after a product labeled for topical use was injected, the clearest published example of route changing the outcome. Disclosure: the author declared no conflicts of interest.
- 8.AlBargawi S. Necrosis Following Dermal Injection of Lyophilized Exosomes: A Case Report. J Cosmet Dermatol. 2025;24(8):e70387. PMID 40820962. PMC12359287. doi:10.1111/jocd.70387Case report (Saudi Arabia); one adult man with tissue necrosis of both cheeks three days after multiple dermal injections of a freeze-dried exosome product. Carries in this article: a serious adverse event after injection of a product outside any registered study. Disclosure: the author declared no conflicts of interest.
- 9.Kwon HH, Yang SH, Lee J, Park BC, Park KY, Jung JY, et al. Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study. Acta Derm Venereol. 2020;100(18):adv00310. PMID 33073298. PMC9309822. doi:10.2340/00015555-3666Prospective, double-blind, randomized, split-face trial over 12 weeks with three fractional CO2 laser sessions (Korea); 25 adults. Carries in this article: a topical exosome gel applied after each laser session, with greater improvement, milder erythema and shorter downtime reported on the exosome side. Disclosure: the exosome and control gels were supplied by the exosome manufacturer; the authors declared no conflicts of interest.
- 10.Park GH, Kwon HH, Seok J, Yang SH, Lee J, Park BC, et al. Efficacy of combined treatment with human adipose tissue stem cell-derived exosome-containing solution and microneedling for facial skin aging: A 12-week prospective, randomized, split-face study. J Cosmet Dermatol. 2023;22(12):3418-3426. PMID 37377400. doi:10.1111/jocd.15872Prospective, randomized, split-face study over 12 weeks, three microneedling sessions three weeks apart, saline on the control side (Korea); 28 adults. Carries in this article: a topical exosome solution applied after microneedling, with higher aesthetic improvement scores and instrument-measured gains on the exosome side and no serious adverse events observed. Disclosure: National Research Foundation of Korea grants listed in the PubMed record.
- 11.Chandran NS, Bhupendrabhai MN, Tan TT, Zhang B, Lim SK, Choo ABH, et al. A phase 1, open-label study to determine safety and tolerability of the topical application of mesenchymal stem/stromal cell (MSC) exosome ointment to treat psoriasis in healthy volunteers. Cytotherapy. 2025;27(5):633-641. PMID 39918488. doi:10.1016/j.jcyt.2025.01.007Phase 1, open-label tolerability study (Singapore); an MSC exosome ointment applied to the forearm three times a day for 20 days in 10 healthy adult volunteers. Carries in this article: the study reported no product-related adverse events, no laboratory abnormalities and no dryness, itch, redness or swelling at the application site, the design of a formal early-phase study of topical use. Disclosure: four authors are employees of the product developer.
- 12.Gaebe K, Lowe K, Bosnalie D, Khoury S, Villemure Poliquin N, Nichols A. Effectiveness and Safety of Extracellular Vesicle-Based Therapies for Nonsurgical Facial Rejuvenation: A Systematic Review. Facial Plast Surg Aesthet Med. 2026. Published online ahead of print. PMID 42487416. doi:10.1177/26893614261457879PRISMA systematic review with risk-of-bias and GRADE assessment, searches to June 2025; 16 studies and 503 participants. Carries in this article: no serious adverse events were reported across the included facial studies, certainty was low or very low, and the authors described the safety signal as short term. Disclosure: academic authors (Canada); no COI statement in the PubMed record.
- 13.Lightner AL, Sengupta V, Qian S, Ransom JT, Suzuki S, Park DJ, et al. Bone Marrow Mesenchymal Stem Cell-Derived Extracellular Vesicle Infusion for the Treatment of Respiratory Failure From COVID-19: A Randomized, Placebo-Controlled Dosing Clinical Trial. Chest. 2023;164(6):1444-1453. PMID 37356708. PMC10289818. doi:10.1016/j.chest.2023.06.024Prospective phase 2, multicenter, double-blind, randomized, placebo-controlled trial at five US sites, registered as NCT04493242; 102 adults with COVID-19-associated moderate to severe ARDS received placebo or 10 mL or 15 mL intravenous infusions on days 1 and 4. Carries in this article: an example of intravenous exosome use in humans conducted as a registered, FDA-regulated trial, in which the authors reported no treatment-related adverse events and a primary mortality outcome that did not reach significance. Disclosure: several authors are employees of the sponsor, the product’s manufacturer.
- 14.ClinicalTrials.gov. NCT04493242. Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS. Phase 2, randomized, placebo controlled; 102 participants; United States (Anaheim, Houston, Lubbock and other sites); completed; FDA-regulated drug product: yes; results posted (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT04493242Registry record of the trial reported by Lightner and colleagues. Carries in this article: an intravenous exosome study in the United States run under FDA oversight, with results posted to the registry, the pattern the FDA pages describe as the legal route for these products.
- 15.ClinicalTrials.gov. NCT06918808. DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn’s Disease. Phase 2, randomized, placebo controlled; 36 participants estimated; United States (New York, Aurora, Nashville and other sites); recruiting, start May 2025; FDA-regulated drug product: yes (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT06918808Registry record of a recruiting US trial of a frozen bone marrow MSC secretome and extracellular vesicle product, manufactured under current good manufacturing practice, with an academic medical center among the sites. Carries in this article: a current example of injected exosome material studied in the United States inside a registered, FDA-regulated trial.
- 16.ClinicalTrials.gov. NCT06429033. Purified Exosome Product (PEP) Injected Into the Hypodermis. Phase 1; 8 participants; United States (Encino, California); completed, start April 2025; FDA-regulated drug product: yes; no results posted (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT06429033Registry record of a small phase 1 safety study of an exosome product injected into the abdominal hypodermis. Carries in this article: even an eight-person injection safety study in the United States was registered as an FDA-regulated drug study, the frame the FDA pages set for any injected use.
- 17.ClinicalTrials.gov. NCT06930326. Exosome Treatment and Hair Growth. Randomized, saline controlled; 24 participants; Malaysia; intradermal scalp injection; completed; no results posted (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT06930326Registry record of a completed randomized study outside the United States in which exosome material or saline was injected into the scalp. Carries in this article: injected protocols exist in registered studies abroad, the FDA states it has no oversight of studies in other countries, and no results were posted to the registry as of the audit date; the registered formulation and injection protocol match the published Amini 2025 pilot [22].
- 18.Schaffer S, Tehrani L, Koechle B, Chandramohan P, Hilburn B, Aoki KC, et al. A Scoping Review of Exosome Delivery Applications in Hair Loss. Cureus. 2025;17(3):e81152. PMID 40276450. PMC12020662. doi:10.7759/cureus.81152Scoping review of EMBASE, Ovid MEDLINE and Web of Science, 2018 to 2023; 16 studies. Carries in this article: the four delivery routes the studies used (intradermal needle injection, microneedle patches, topical application, and topical application after an assistive device), the vocabulary behind "how are exosomes applied". Disclosure: osteopathic medical school authors (Florida); no funding statement in the PubMed record.
- 19.Soltani-Arabshahi R, Wong JW, Duffy KL, Powell DL. Facial allergic granulomatous reaction and systemic hypersensitivity associated with microneedle therapy for skin rejuvenation. JAMA Dermatol. 2014;150(1):68-72. PMID 24258303. doi:10.1001/jamadermatol.2013.6955Case series (USA); three women with facial granulomas after microneedling with a topical serum, two with a positive patch test to the same serum. Carries in this article: the authors concluded that a topical product applied with microneedling can carry immunogenic particles into the dermis, the reason topical use after a device is read with the device’s limits in mind. No exosome product was involved.
- 20.Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, Blenkiron C, Bussolati B, et al; MISEV Consortium; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024;13(2):e12404. PMID 38326288. PMC10850029. doi:10.1002/jev2.12404International Society for Extracellular Vesicles reporting guideline, compiled with ISEV task forces and more than 1,000 researchers. Carries in this article: the reporting headings (source, separation, particle size and concentration, marker proteins, morphology) that a trial sponsor’s characterization and a practice’s lot documents can be read against. Disclosure: many consortium authors list EV company affiliations, declared in full in the article.
- 21.U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of 11/03/2026; verified 4 November 2026. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-programAgency reporting program page. Carries in this article: the voluntary reporting route for health professionals, patients and consumers that both FDA exosome notices point to for any adverse event.
- 22.Amini F, Teh JJ, Tan CK, Tan ESS, Ng ESC. A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation for Treating Male Alopecia. Life (Basel). 2025;15(3):500. PMID 40141845. PMC11943915. doi:10.3390/life15030500Pilot randomized, saline-controlled trial (Malaysia); 20 men, a plant-extract exosome formulation or 0.9 percent saline given by intradermal scalp injection (0.05 to 0.1 mL per site, 5 mL per session) in four sessions two weeks apart, counts to week 16. Carries in this article: a published controlled study in which the material was injected, outside the United States, with the same formulation and injection protocol as registry entry NCT06930326. Disclosure: the authors declared no conflicts of interest.