Published human studies report that exosome material applied to the scalp was followed by measurable gains in hair density, with increases of 9.5 to 35 hairs per square centimeter across the 11 clinical studies in a 2025 systematic review, and the review noted no serious adverse events [1]. The same review counted only two randomized trials among those 11 studies, and the FDA states that there are currently no FDA-approved exosome products, so the published results are early and positive and the evidence base remains small [1, 16].
Patients weighing the question and hair clinics explaining it tend to ask four things next: what the studies measured and at which visits, how the figures compare with the platelet-rich plasma meta-analyses, what the registered trials will add, and what the FDA has said. Each is answered below from the published record, and every clinical decision belongs to the licensed practitioner.
Regulatory status
The FDA stated in its 2019 public safety notification that there are currently no FDA-approved exosome products, and its consumer alert, current as of 2024, repeats that statement [16, 17]. 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. Whether and how any material is used for a particular patient is a decision for that patient’s licensed practitioner.
Published human studies report density gains after scalp application
Al Ameer and colleagues searched PubMed, Scopus and Embase to May 2025 and found 11 clinical studies of exosome material in hair loss: two randomized trials, three retrospective studies, three prospective single-arm studies, one case series and two case reports [1]. Every study reported improvement in at least one hair parameter, with density gains of 9.5 to 35 hairs per square centimeter and thickness gains of up to 13.01 micrometers [1].
Queen and Avram reviewed 48 human studies of exosome products across dermatology in 2025 and found nine relevant to alopecia, in which 125 patients received exosome material on the scalp [2]. Side effects in the hair studies were rare, while the wider dermatology literature carried at least 10 serious adverse events, and the authors asked for larger trials with longer follow-up and for consistent manufacturing standards [2].
The 2026 scoping review by Ahmad and colleagues covered 80 preclinical and clinical studies and placed the clinical evidence at 11 studies with more than 330 patients, with density gains of 25 to 35 hairs per square centimeter and effects described as sustained up to one year [3]. Three years earlier, Gupta and colleagues had located a single clinical study among 16, so the human literature has grown from one study to about a dozen in a short time [4].
Follow-up points in the open-label studies run from four to twelve months
The open-label studies give the clearest picture of what was measured and when. Wan and colleagues followed 16 men aged 36 to 45 for 12 months after scalp microneedling and topical application of an exosome product, and reported a mean density gain of 35 hairs per square centimeter from baselines of 75 to 95, with 80 percent of participants reporting noticeable improvement [6].
| Study | Design and size | Sequence studied | Follow-up points | Measured result |
|---|---|---|---|---|
| Wan 2025 [6] | Open-label, 16 men | Microneedling, then topical exosome product | 1, 3, 6 and 12 months | Mean gain of 35 hairs per square centimeter at 12 months; mild tenderness that resolved |
| Koumprentziotis 2025 [7] | Open-label, 20 adults (16 men, 4 women) | Microneedling radiofrequency, then topical exosome product | 3, 6 and 9 months; median follow-up 10 months | Significant increases in mean density and diameter; no adverse events |
| Ablon 2025 [8] | Single-arm, 30 adults (15 men, 15 women) | Microneedling, then topical exosome complex, days 0, 30, 60 and 90 | Day 120 | Higher terminal and vellus hair counts, more follicular units, less shedding; no adverse events |
| Amini 2025 [9] | Pilot randomized, placebo-controlled, 20 men | Intradermal injection of a plant-extract exosome formulation or saline, four sessions two weeks apart | Week 16 | Median hair count change 9.5 against 1.5 with placebo |
| Gupta 2023 review [4] | One clinical study among 16 | Topical adipose-derived exosomes in 39 adults | Study-defined | Increased density and thickness reported |
Koumprentziotis and colleagues measured 20 adults with trichoscopy at three, six and nine months after microneedling radiofrequency followed by topical exosome application, reported significant increases in mean hair density and diameter with no adverse events, and found the response independent of sex and severity [7]. Ablon applied a topical exosome complex after microneedling on days 0, 30, 60 and 90 in 30 adults and reported higher terminal and vellus hair counts and less shedding at day 120 [8].
Three features recur across these studies: a microneedling step before the material, a short series of sessions, and first measurements between one and four months. Ablon reported four sessions 30 days apart and the Amini pilot trial four sessions two weeks apart, which is the published reference point for "how many exosome treatments for hair", and the before-and-after photographs in the papers were reported at the same visits, out to twelve months [6, 7, 8, 9].
Randomized comparisons remain few and small
Amini and colleagues ran one of the two randomized comparisons in the 2025 review, a pilot trial of 20 men with Norwood grade 2 to 3 hair loss who received intradermal injections of a plant-extract exosome formulation or saline in four sessions two weeks apart [9]. At week 16 the median hair count change was 9.5 in the exosome group and 1.5 with placebo, a difference the authors reported as significant with a large effect size [9].
Al Ameer and colleagues identified only two randomized trials among the 11 clinical studies, Nadeem 2024 with 85 patients and the Amini pilot with 20 men, both using intradermal injection, and rated them the highest level of evidence available, while noting that heterogeneity in design and outcomes limited direct comparison [1, 9]. Tian and colleagues published the protocol of a randomized controlled trial of umbilical cord mesenchymal stem cell-derived small extracellular vesicles against topical minoxidil in young men in 2026, and a 120-participant phase 2 trial against saline began recruiting in Beijing in April 2026 [13, 15].
The human literature has grown from a single clinical study in 2023 to about a dozen in 2025, and the randomized trials that will settle the question are now registered.
Platelet-rich plasma supplies the published comparator
Cruciani and colleagues pooled 27 controlled trials with 1,117 participants in 2023, 18 of them in androgenetic alopecia, and reported that PRP injections increased hair density over saline by 25.6 hairs per square centimeter at medium-term follow-up, with a wide confidence interval of 2.62 to 48.57 and evidence rated low quality [10]. No serious adverse events were related to PRP or to the control injections [10].
That pooled PRP figure sits inside the 9.5 to 35 range reported for the exosome studies, which is the fairest way to read "exosomes vs PRP for hair" today: the two sets of numbers overlap, and the PRP figure rests on far more participants [1, 10]. Darwish and colleagues concluded in a 2025 narrative comparison that the exosome studies showed the most promising regrowth results, followed by PRP, and called for further research before that ranking guides decisions [12].
Pei and colleagues pooled 13 randomized trials with 696 adults and reported that combining microneedling with a topical or injected agent improved density over the single agent by 13.36 hairs per square centimeter [11]. Because almost every exosome study used microneedling first, part of the measured gain belongs to the device, a point the reviews make and a reason the saline-controlled trials matter [1, 11].
A registered head-to-head trial has already been completed. NCT06239207 randomized 30 adults in Lahore to an exosome scalp kit or PRP with a primary outcome of more than a 25 percent increase in hair density six months after the last session; it finished in July 2024 and its results had not been posted as of this audit [14].
Understanding what the evidence does not yet show
The reviews are consistent about the gaps, and each gap is a reason the figures above are read as early rather than settled. The points below summarize them.
- Randomized evidence is thin: Al Ameer 2025 found two randomized trials among 11 clinical studies, Nadeem 2024 with 85 patients and the Amini 2025 pilot with 20 men [1, 9].
- Durability beyond a year is unmeasured: the longest follow-up in the open-label studies is 12 months, and Ahmad 2026 describes effects as sustained up to one year with nothing reported past it [3, 6].
- The microneedling step is confounded with the material: Pei 2024 shows the device alone adds measurable density when combined with an agent, and few exosome studies had a saline-plus-device arm [11].
- Products differ by source and preparation: the reviewed studies used adipose, placental, umbilical cord, follicle and plant-derived material, so a result for one product does not transfer to another [1, 5].
- Women are under-represented: Wan 2025 and Amini 2025 enrolled men only, and the mixed studies enrolled 4 and 15 women [6, 7, 8, 9].
- Industry ties are common: products and their manufacturers are named in several papers, and authors in three of the cited studies hold company affiliations [3, 6, 7, 8].
- Serious harms exist in the wider literature: Queen and Avram counted at least 10 serious adverse events across dermatology, none in the hair studies [2].
Delivery route and device status shape how the studies were run
Schaffer and colleagues mapped 16 hair-related studies from 2018 to 2023 and found four delivery routes: intradermal needle injection, microneedle patches, topical application, and topical application after an assistive device, with 14 of the 16 using mesenchymal stem cell-derived vesicles [5]. The open-label human studies cited here all used the last of those routes, with the material applied to the scalp after a microneedling or radiofrequency microneedling pass [6, 7, 8].
The device carries its own regulatory 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, and that the risks of combining the devices with other products are not known [18].
Injected protocols appear in both published randomized trials, which used intradermal scalp injection outside the United States, and in the registered trials, while the open-label studies used topical application after microneedling [1, 9]. The recruiting Beijing trial uses intradermal scalp injection of umbilical cord-derived exosomes against saline inside a registered phase 2 design [15]. The FDA notification tells patients they may ask a clinical investigator for the FDA-issued IND number before taking part in any study in the United States [16].
Understanding the FDA position on exosome products
The FDA stated in December 2019 that there are currently no FDA-approved exosome products, after reports of serious adverse events in patients in Nebraska who received unapproved products marketed as containing exosomes [16]. The notification states that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products and are subject to premarket review and approval [16].
The agency’s consumer alert, issued in 2020 and current as of April 2024, says the FDA has authority over exosome products, warns of misleading online information about the conditions these products can address, and points patients and practitioners to MedWatch for adverse events [17]. A reader who meets a claim that an exosome product is approved for hair has met a claim the agency contradicts [16, 17].
ExaVeyra Sciences supplies exosome material for topical aesthetic use by licensed practitioners, and for laboratory research and clinical research conducted under an IND. Every vial carries its lot number, a certificate of analysis with serology exists for every lot, and the certificate, characterization panel and cold-chain records are available on request, so a practice or a study team can document what it received.
Reading a hair study report with the right questions
The studies above share a measurement vocabulary, and a reader who knows it can weigh any new report or clinic claim. The questions below follow the reporting of the papers cited here.
- Was hair density counted with trichoscopy or phototrichogram, and at which months? The cited studies report at 3, 4, 6, 9 and 12 months [6, 7, 8].
- Was there a control arm, and what did it receive? Saline controls appear in Amini 2025 and in the registered Beijing trial [9, 15].
- Did a microneedling or radiofrequency pass come first? If so, part of the gain belongs to the device [11].
- What was the material: its tissue source, its preparation and its lot? The reviews report adipose, placental, cord, follicle and plant-derived products [1, 5].
- Who funded the study and who made the product? Several papers name the manufacturer [6, 8].
- How many participants, and how many were women? Al Ameer 2025 reports study sizes from 1 to 85 participants, the largest a randomized trial of 85 [1].
Documented material supports the next tier of evidence
The hair studies that will answer this question well are the controlled randomized trials now registered, one against saline and one against minoxidil, and they depend on characterized material with a traceable lot [13, 15]. ExaVeyra Sciences supplies exosome material with the lot number on every vial and a certificate of analysis for every lot, with the characterization panel and cold-chain records available on request, which is the paper trail a trial sponsor or a practice file needs.
Anyone may ask our scientific team a question or apply for an account without an NPI, and NPI verification, which takes 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, so a practice or study team can begin with documented material and build its own measured record as the literature grows.
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.Al Ameer MA, Alnajim AT, Al Ameer A, Alsalman Z, Al Ameer GA, Alnajim ST, et al. Exosomes and Hair Regeneration: A Systematic Review of Clinical Evidence Across Alopecia Types and Exosome Sources. Clin Cosmet Investig Dermatol. 2025;18:2215-2227. PMID 40955427. PMC12433634. doi:10.2147/CCID.S543451Systematic review with OCEBM levels and RoB 2 and ROBINS-I risk-of-bias tools, searches to 10 May 2025; 11 clinical studies (two randomized trials, Nadeem 2024 with 85 patients and Amini 2025 with 20, both by intradermal injection; three retrospective studies, three prospective single-arm studies, one case series, two case reports). Carries in this article: every included study reported improvement in at least one hair parameter, density gains ran from 9.5 to 35 hairs per square centimeter, thickness gains reached 13.01 micrometers, no serious adverse events were noted, and heterogeneity limited direct comparison. Disclosure: academic dermatology authors (Saudi Arabia); no funding statement in the PubMed record.
- 2.Queen D, Avram MR. Exosomes for Treating Hair Loss: A Review of Clinical Studies. Dermatol Surg. 2025;51(4):409-415. PMID 39447204. doi:10.1097/DSS.0000000000004480Literature review of PubMed, Embase and Cochrane; 48 human studies across dermatology, nine of them on alopecia, with 125 patients who received exosome material on the scalp. Carries in this article: side effects were rare in the hair studies, at least 10 serious adverse events were reported in the wider dermatology literature, and the authors called for larger trials with longer follow-up and for consistent manufacturing standards. Disclosure: academic and private-practice dermatologists (New York); no funding statement in the PubMed record.
- 3.Ahmad P, Davies C, Sculean A, Miron RJ. Understanding Exosomes in Hair Regeneration. Periodontol 2000. 2026. Published online ahead of print. PMID 42521333. doi:10.1111/prd.70057Narrative-scoping review of PubMed, Scopus and Web of Science; 80 preclinical and clinical studies. Carries in this article: the clinical evidence came from 11 studies with more than 330 patients, reported density gains of 25 to 35 hairs per square centimeter with effects described as sustained up to one year, and side effects described as transient and mild. Disclosure: one author is employed by a PRF education company and one by a hair clinic, as the affiliations state.
- 4.Gupta AK, Wang T, Rapaport JA. Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions. J Cosmet Dermatol. 2023;22(9):2424-2433. PMID 37381168. doi:10.1111/jocd.15869PRISMA systematic review, search January 2023; 16 studies, 15 preclinical and one clinical. Carries in this article: the single clinical study the authors located applied adipose-derived stem cell exosomes topically in 39 adults with androgenetic alopecia and reported increases in hair density and thickness, the baseline the 2025 reviews grew from. Disclosure: two authors are affiliated with a contract research company and one with a hair restoration practice.
- 5.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 retained from 1,087 records. Carries in this article: the delivery routes the studies used (intradermal needle injection, microneedle patches, topical application, and topical application with an assistive device) and the finding that 14 of 16 studies used mesenchymal stem cell-derived vesicles. Disclosure: osteopathic medical school authors (Florida); no funding statement in the PubMed record.
- 6.Wan J, Kim SB, Cartier H, Garson S, Frank K, Haykal D, et al. [A prospective study of exosome material applied for androgenetic alopecia]. Aesthetic Plast Surg. 2025;49(11):3151-3156. PMID 40146273. doi:10.1007/s00266-025-04817-9Prospective, open-label, single-arm study (Korea); 16 men aged 36 to 45 with mild to moderate androgenetic alopecia, scalp microneedling followed by topical application of an exosome product, assessed at 1, 3, 6 and 12 months. Carries in this article: a mean density gain of 35 hairs per square centimeter (standard deviation 6.5) at 12 months from baselines of 75 to 95, 80 percent of participants reporting noticeable improvement, and mild tenderness and irritation that resolved. Disclosure: the first author is affiliated with a medical research company; the product was named in the paper.
- 7.Koumprentziotis IA, Kroumpouzos E, Delavar S, Kroumpouzos G. Microneedling radiofrequency followed by topical exosome application therapy for pattern hair loss: A scoping review and prospective study. Clin Dermatol. 2025;43(5):742-751. PMID 40744280. doi:10.1016/j.clindermatol.2025.07.006Scoping review (nine exosome studies located) plus a prospective single-arm study; 20 adults (16 men, four women, median age 46) with pattern hair loss, microneedling radiofrequency followed by topical exosome application, trichoscopy at baseline, 3, 6 and 9 months, median follow-up 10 months. Carries in this article: significant increases in mean hair density and diameter, no adverse events, and a response the authors found independent of sex and severity. Disclosure: one author is employed by a tissue and biologics company, as the affiliations state.
- 8.Ablon G. An Exosome Regenerative Complex Plus Microneedling Promotes Hair Growth in Subjects With Self-Perceived Thinning Hair. J Drugs Dermatol. 2025;24(10):988-994. PMID 41037530. doi:10.36849/JDD.9244Single-arm study registered as NCT06571799; 30 adults (15 men, 15 women, mean age 50.2) with self-perceived thinning hair, a topical exosome complex applied after scalp microneedling on days 0, 30, 60 and 90, final assessment on day 120. Carries in this article: trichoscopy showed increased terminal and vellus hair counts, more follicular units per square centimeter and less shedding at day 120, with no adverse events reported. Disclosure: the product and its manufacturer are named in the paper; the PubMed record carries no funding statement.
- 9.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, placebo-controlled trial (Malaysia); 20 men with Norwood grade 2 to 3 androgenetic alopecia, a plant-extract exosome formulation or saline by intradermal scalp injection in four sessions two weeks apart, hair counts to week 16. Carries in this article: median hair count change of 9.5 in the exosome group against 1.5 with placebo, a between-group difference the authors reported as significant with a large effect size, and no notable adverse effects. Disclosure: the authors declared no conflicts of interest.
- 10.Cruciani M, Masiello F, Pati I, Marano G, Pupella S, De Angelis V. Platelet-rich plasma for the treatment of alopecia: a systematic review and meta-analysis. Blood Transfus. 2023;21(1):24-36. PMID 34967722. PMC9918380. doi:10.2450/2021.0216-21Systematic review and meta-analysis with GRADE assessment; 27 controlled trials and 1,117 participants, 18 of the trials (713 participants) in androgenetic alopecia. Carries in this article: against saline injections, PRP injections increased hair density by a pooled 25.6 hairs per square centimeter over medium-term follow-up (95 percent CI 2.62 to 48.57), rated low quality for inconsistency and risk of bias, with no serious adverse events, the comparator figure for the exosome studies. Disclosure: authors at Italy’s national blood service; the authors declared no conflicts of interest.
- 11.Pei D, Zeng L, Huang X, Wang B, Liu L, Zhang G. Efficacy and safety of combined microneedling therapy for androgenic alopecia: A systematic review and meta-analysis of randomized clinical trials. J Cosmet Dermatol. 2024;23(5):1560-1572. PMID 38239003. doi:10.1111/jocd.16186Systematic review and meta-analysis of randomized trials, 2012 to 2022; 13 trials and 696 adults with androgenetic alopecia. Carries in this article: combining microneedling with a topical or injected agent improved hair density over the single agent by a pooled 13.36 hairs per square centimeter (95 percent CI 8.55 to 18.16) with no difference in adverse reactions, the reason the microneedling step in the exosome studies has to be read as part of the effect. Disclosure: academic dermatology authors (China); no funding statement in the PubMed record.
- 12.Darwish R, Zakhary M, Wingate K, Ayoubi N, Ghafoor F, Ejaz B. [From cells to strands: a systematic review comparing exosome material, platelet-rich plasma and minoxidil in androgenetic alopecia]. Cureus. 2025;17(7):e87875. PMID 40821339. PMC12351504. doi:10.7759/cureus.87875Systematic review comparing three approaches, without a pooled analysis. Carries in this article: the authors’ conclusion that the exosome studies showed the most promising regrowth and safety results, followed by PRP, with a call for further research to guide decisions; the article is a narrative synthesis and is weighed as such. Disclosure: the authors declared no financial support and no competing relationships.
- 13.Tian R, Deng Z, Chen F, Xiong B, Song L, Shi C, et al. A Randomized Controlled Clinical Trial Protocol of Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles for the Treatment of Androgenetic Alopecia in Young Males. FASEB J. 2026;40(2):e71496. PMID 41591820. doi:10.1096/fj.202504430Published protocol of a randomized controlled trial (China, ChiCTR2500109770) of umbilical cord mesenchymal stem cell-derived small extracellular vesicles in young men with androgenetic alopecia, with intradermal dose escalation in phase I and topical 5 percent minoxidil as the phase II comparator. Carries in this article: an example of the randomized, controlled design the reviews have asked for, published as a protocol with results still to come. Disclosure: not stated in the PubMed record.
- 14.ClinicalTrials.gov. NCT06239207. Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia. Services Hospital, Lahore (Pakistan). Phase 2, randomized, open label; 30 participants; started September 2023, completed July 2024; record last updated October 2024; no results posted (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT06239207Registry record of a completed head-to-head trial. Carries in this article: the comparison the search phrase "exosomes vs PRP for hair" asks about has been run once as a registered randomized trial, with a primary outcome of more than a 25 percent increase in hair density six months after the last session, and its results were not posted as of the audit date. The registered exosome arm used a commercial scalp kit.
- 15.ClinicalTrials.gov. NCT07693244. [Exosome material in male androgenetic alopecia]. Beijing (China). Phase 2, randomized, saline controlled; 120 participants estimated; recruiting, start date April 2026 (read through the ClinicalTrials.gov v2 API, verified 4 November 2026). https://clinicaltrials.gov/study/NCT07693244Registry record of a recruiting randomized trial of umbilical cord mesenchymal stem cell-derived exosomes against saline by intradermal scalp injection. Carries in this article: the largest randomized hair study registered to date, an injected protocol run inside a registered trial, and a sign of where the next tier of evidence will come from.
- 16.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 agency statement that there are currently no FDA-approved exosome products, that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, and that patients may ask a clinical investigator for the FDA-issued IND number before taking part in a study.
- 17.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, states that there are currently no FDA-approved exosome products, warns of misleading online information about the conditions these products can address, and points patients and practitioners to MedWatch for adverse events.
- 18.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, states that the devices are not approved for delivering cosmetics, topical medications, drugs or blood products into the skin, and says the risks of combining the devices with other products are not known.