Platelet-rich plasma and platelet-rich fibrin are both concentrates of a patient’s own platelets, and they differ in three preparation choices: whether an anticoagulant is added, how hard and in what rotor the blood is spun, and whether the leukocytes and fibrin are kept. Those choices change the cell content, the physical form and the timing of growth-factor release.
This review sets out the classification systems, the preparation physics and chemistry, the release kinetics measured in the laboratory, and what the facial, hair and rotator cuff studies reported for each. It also covers the question practices now ask most often, how exosome material compares with both, and closes with the US regulatory position and a documentation checklist. It is written for aesthetic, dermatology, orthopedic and regenerative practices and for investigators who need a preparation described precisely enough to reproduce.
Regulatory position, stated once
The federal definition of HCT/Ps at 21 CFR 1271.3(d)(2) excludes listed blood components, and Beitzel and colleagues described point-of-care PRP as falling outside Part 1271 in 2015. PRP preparation systems reach the US market through 510(k) clearance under 21 CFR 864.9245, where product code ORG describes preparing platelet-rich plasma for mixing with bone graft; no FDA product code names platelet-rich fibrin. Which preparation, for which patient and by which route are practitioner decisions this article does not make, and ExaVeyra Sciences supplies neither PRP nor PRF kits.
Four classification systems describe the same few variables
Dohan Ehrenfest, Rasmusson and Albrektsson proposed the foundational scheme in 2009, sorting platelet concentrates into four families by leukocyte and fibrin content: pure PRP, leukocyte-rich PRP, pure PRF and leukocyte-rich PRF. The families remain the clearest way to place any commercial system.
Later systems add amount and handling. DeLong and colleagues proposed PAW in 2012, grading platelet count, activation and white cells; Magalon and colleagues proposed DEPA in 2016 and, applying it to 20 commercial preparations, reported a 25-fold spread in the number of platelets delivered and no device recovering more than 90 percent of blood platelets. Lana and colleagues proposed MARSPILL in 2017, adding harvest method, red cells, number of spins, image guidance and light activation.
The International Society on Thrombosis and Haemostasis reviewed the field in 2018 and reported that controlled trials were few and preparations poorly defined, too few for evidence-based guidelines, and issued consensus recommendations and a classification proposal instead. A preparation described by one of these systems can be compared with another; one described only by a brand name cannot.
| Family | Anticoagulant | Leukocytes | Physical form | Common names |
|---|---|---|---|---|
| Pure PRP (P-PRP) | Yes, typically citrate | Largely removed | Liquid until activated | Plasma-sampling PRP kits |
| Leukocyte-rich PRP (L-PRP) | Yes, typically citrate | Retained with the buffy coat | Liquid until activated | Buffy-coat PRP kits |
| Pure PRF (P-PRF) | Yes at collection, then recalcified to form fibrin | Largely removed | Fibrin matrix | PRFM |
| Leukocyte-rich PRF (L-PRF) | None | Retained in the clot | Clot or membrane; liquid if spun briefly | L-PRF, A-PRF, i-PRF |
Centrifugal force, rotor geometry and tube surface shape the product
Relative centrifugal force is the variable that transfers between centrifuges, because it depends on rotor radius as well as speed, which rpm alone does not capture. Miron, Pinto, Quirynen and Ghanaati reported in 2019 that force values in PRF studies had often been misreported, and listed what a reproducible method states: rotor radius at clot and tube end, rotor angle, rpm and time, force at minimum, clot and maximum, tube composition and size, and centrifuge model.
Choukroun and Ghanaati reported in 2018 that lowering force from 710 to 177 to 44 g at constant time increased platelets, leukocytes, VEGF and TGF-beta1 in liquid PRF, the basis of the low-speed centrifugation concept. Miron and colleagues reported in 2019 that horizontal rotors yielded up to 3.5-fold more platelets and leukocytes than fixed-angle rotors, and Fujioka-Kobayashi and colleagues described more uniform cell separation in horizontal systems in 2021.
A protocol written in rpm describes one centrifuge. A protocol written in g-force, rotor type and time describes a preparation.
The tube matters too. PRF forms without anticoagulant because contact activation starts coagulation, and plastic tubes rely on silica coatings to trigger it. Tsujino and colleagues reported in 2019 that silica microparticles were incorporated into PRF-like matrices from all three brands of coated tubes they tested, noted that most such tubes are approved for diagnostic use only, and called for study of possible inflammatory effects.
Dohan Ehrenfest and colleagues reported in 2010 that an L-PRF clot captured about 97 percent of platelets and more than half the leukocytes in a dense fibrin network, with no architectural difference between dry glass and glass-coated plastic tubes. On the PRP side, Ulasli and colleagues reported in 2022 that standard-volume citrate gave the highest platelet capture and PDGF and TGF-beta1 totals, while omitting anticoagulant gave the most leukocytes and VEGF.
Kit design produces the largest differences of all. Fitzpatrick and colleagues ran four commercial PRP kits on the same blood in 2017 and reported that three buffy-coat kits concentrated platelets and leukocytes about three to six times above baseline while one plasma-sampling kit reached about 1.5 times, with the kits supplied by their manufacturers as the paper declares.
PRP releases growth factors early, and PRF releases them over days
Kobayashi and colleagues measured release to ten days in 2016 and reported that PRP released significantly more growth factors in the first 15 to 60 minutes, while A-PRF released the highest totals at later time points and across ten days, with PDGF-AA the most abundant factor measured.
Miron and colleagues compared PRP with injectable i-PRF in 2017 and reported higher early release from PRP, higher ten-day totals of PDGF-AA, PDGF-AB, EGF and IGF-1 from i-PRF, and higher ten-day TGF-beta1 and VEGF from PRP. Fujioka-Kobayashi and colleagues and El Bagdadi and colleagues reported greater release with lower-force protocols in 2017 and 2019, and Masuki and colleagues, an independent group, reported comparable or higher growth-factor content in A-PRF than PRP in 2016.
Reading the release literature
Much of the low-speed and horizontal-centrifuge research comes from one group, and members of it hold intellectual property on PRF production or own a PRF supplier, as the annotated references record. Independent studies such as Masuki 2016 and Tsujino 2019 are the useful cross-check, and in vitro release is a laboratory measure that the clinical studies below test separately.
Clinical comparisons point in different directions by site
Facial and periorbital studies found neither preparation superior
In facial aesthetics the comparison is close. Sollitto, Narduzzi and Wolinsky reviewed 14 periorbital studies in 2025 and reported PRF associated with texture, wrinkle and crepiness improvement and PRP with stronger evidence for hyperpigmentation, with PRF gains often diminishing by six months and no evidence that either was superior. Evans and colleagues meta-analyzed PRP alone in the periorbital region in 2021, 19 studies of 455 patients, and reported higher satisfaction than controls across three randomized trials at a mean follow-up of three months.
Qin and colleagues reviewed 20 studies of 514 patients in 2025 and reported that skin thickness and elasticity improved most consistently, in 80 and 75 percent of the studies measuring them, against 40 percent for wrinkles, 33 percent for texture and 17 percent for dyschromia. Hu and colleagues ran a randomized split-face trial of a platelet-rich fibrin matrix against saline in 30 adults in 2021 and reported a difference in overall skin score and texture at six weeks that was no longer significant at twelve.
Direct PRF and PRP comparisons in skin are few and small. Diab and colleagues compared fluid PRF with PRP in 30 adults with atrophic acne scars in 2023 and reported a higher response with PRF, alone and with needling. Ahmed and colleagues randomized 30 adults with abdominal striae to microneedling followed by PRF on one side and PRP on the other in 2025 and found both sides improved with no statistically significant difference between them, and a registered Zagazig University trial of the same comparison, NCT07561671, completed in 2026 without posted results.
In one randomized hair trial, i-PRF and CGF exceeded PRP on hair count
In female pattern hair loss, 74 women completed a randomized trial by Li and colleagues in 2026 comparing PRP, i-PRF and concentrated growth factor, which reported larger percentage increases in hair count with i-PRF and CGF, 26.5 and 27.1 percent, than with PRP at 14.5 percent, no difference in hair diameter, and the fewest adverse events with i-PRF. For PRP alone, Cruciani and colleagues at the Italian National Blood Centre identified 27 controlled trials of 1,117 subjects in alopecia and, in the saline-controlled comparisons, reported a hair density gain of 25.6 hairs per square centimeter, which they rated low-certainty evidence.
Pooled rotator cuff trials favor PRP
In rotator cuff repair the pooled evidence favors PRP. Hurley and colleagues meta-analyzed 18 randomized trials of 1,147 patients in 2019 and reported incomplete tendon healing in 17.2 percent with PRP against 30.5 percent with control, while PRF showed no significant effect. Li and colleagues pooled 23 trials of 1,440 patients in 2022 and Peng and colleagues pooled 10 trials of 628 patients in 2023, both reporting the same direction.
Rodeo and colleagues randomized 79 patients in 2012 to a fibrin matrix at the repair or standard repair and reported no overall difference in tendon-to-bone outcome, 67 against 81 percent intact; in their regression analysis the fibrin matrix predicted a tendon defect at twelve weeks.
| Study | Design | n | What was measured | Follow-up |
|---|---|---|---|---|
| Sollitto 2025, periorbital | Systematic review, PRF and PRP | 14 studies | Texture, wrinkles, crepiness, pigmentation, satisfaction | To 6 months in included studies |
| Evans 2021, periorbital | Systematic review and meta-analysis, PRP | 19 studies, 455 patients | Wrinkles, pigmentation, photoaging, satisfaction | Mean 3 months |
| Qin 2025, facial aging | Systematic review, PRP or PRF alone | 20 studies, 514 patients | Six skin parameters by study | Varied by study |
| Hu 2021, cheek | Randomized split-face, PRFM vs saline | 30 | VISIA skin score and subscores | 12 weeks |
| Diab 2023, acne scars | Comparative, fluid PRF vs PRP, with and without needling | 30 | Quartile grading, satisfaction | After 4 sessions, 3 weeks apart |
| Ahmed 2025, striae | Randomized split-abdomen, microneedling plus PRF vs PRP | 30 | Davey score, GAIS, striae width, histology | 1 month after the third monthly session |
| Estupiñan 2025, photoaging | Investigator-blinded split-face, exosome material vs PRP after RF microneedling | 15 enrolled | Graded photographs, biopsies for collagen and GAGs | 6 months |
| Li 2026, female pattern hair loss | Randomized 3-arm, PRP vs i-PRF vs CGF | 74 completers | Target-area hair count, hair diameter, adverse events | 24 weeks |
| Cruciani 2023, alopecia | Systematic review and meta-analysis, PRP, GRADE | 27 trials, 1,117 | Hair density, regrowth | Medium term |
| Hurley 2019, rotator cuff | Meta-analysis of RCTs | 18 RCTs, 1,147 | Incomplete repair on imaging, Constant score, pain | Final follow-up by trial |
| Li 2022, rotator cuff | Meta-analysis of RCTs | 23 RCTs, 1,440 | Retear, function scores, pain | Final follow-up by trial |
| Peng 2023, rotator cuff | Meta-analysis of RCTs | 10 RCTs, 628 | Retear, Constant and UCLA scores | Final follow-up by trial |
| Rodeo 2012, rotator cuff | Blinded RCT, PRFM vs standard repair | 79 | Ultrasound tendon integrity, vascularity, strength | 12 weeks imaging, 1 year minimum |
| Farshidfar 2025, all fields | Systematic review, PRP vs i-PRF | 23 studies | Laboratory, animal and clinical endpoints | Varied by study |
Read together, the clinical comparisons differ by site, and the pooled evidence is clearest at the tendon-bone interface, where three meta-analyses favored PRP and found no benefit from PRF.
Exosome material differs from both concentrates in origin and documentation
Exosome material differs from both platelet concentrates in origin and handling. PRP and PRF are prepared at the point of care from the patient’s own blood, while exosome material is manufactured from cultured cells, characterized by lot and shipped frozen, with a certificate of analysis for the lot available on request. The comparison practices search for most is therefore a comparison of a point-of-care preparation with a manufactured, lot-documented material.
The published head-to-head evidence is a single small study. Estupiñan, Ly and Goldberg ran an investigator-blinded split-face trial in 2025 in 15 adults with photoaged skin, applying PRP to one side and topical exosome material to the other after each of three radiofrequency microneedling sessions, and reported equal improvement in wrinkling, dyschromia, erythema and texture with no histological difference at six months. The clinical scores were not tested statistically because of the sample size, biopsies came from the first 10 participants, and the adipose stem cell exosome product used was the study sponsor’s. The study was not randomized and was supported in part by a grant from that manufacturer, and a registered randomized comparison of exosome material and PRP in androgenetic alopecia, NCT06239207, completed in 2024 without posted results.
Combining the two remains a research question. Gupta and colleagues reviewed the literature in 2025 and noted that PRP is itself a rich source of platelet-derived extracellular vesicles, with preclinical wound-model data and scarce information for hair and skin, and Miron and colleagues proposed i-PRF in 2024 as a possible carrier for biomolecules including exosomes; the same group has since reported two uncontrolled dental case series combining exosomes with PRF, in 2026. Our search of PubMed in October 2026 found no controlled trial of exosome material mixed with PRP or PRF in aesthetic use, so stability, compatibility and outcome data for such mixtures are not yet published.
Supplier position on exosome material
Exosome material is supplied for topical aesthetic use by licensed practitioners. ExaVeyra Sciences makes no statement about mixing it with PRP, PRF or any other preparation, and the practitioner decides whether and how materials are combined, following the manufacturer’s labeling.
The evidence remains small, short and often industry-linked
- Head-to-head trials are few and small. Most facial and hair comparisons enrolled 15 to 74 people, and several were split-face or split-side designs without randomization or with a single site.
- Durability is uncertain. Sollitto and colleagues reported that PRF gains often faded by six months, Hu and colleagues saw their six-week difference fade by twelve weeks, and Evans and colleagues called for long-term follow-up.
- Preparations are rarely described well enough to repeat. Chahla and colleagues reported in 2017 that 10 percent of 105 orthopaedic clinical PRP studies gave a reproducible protocol and 16 percent reported the composition of the final product.
- Certainty is often low. Cruciani and colleagues rated the pooled PRP hair evidence low-certainty by GRADE, and the ISTH working party found too few controlled trials for evidence-based guidelines.
- Much of the PRF literature comes from one research network whose members hold PRF intellectual property or own a PRF supplier, and the only exosome and PRP comparison was supported by the exosome manufacturer.
- Laboratory release kinetics are a proxy. Higher growth-factor totals in vitro have not been shown to predict a clinical difference, and in rotator cuff repair PRF showed no benefit.
- The safety of silica microparticles carried into PRF from coated plastic tubes has not been studied clinically, as Tsujino and colleagues noted.
- No published controlled trial has tested exosome material combined with PRP or PRF, and no exosome product is FDA-approved.
Neither PRP nor PRF is FDA-approved, and only PRP systems are cleared devices
Neither PRP nor PRF is an FDA-approved product, and neither is cleared as a product in its own right. 21 CFR 1271.3(d)(2) excludes listed blood components from the definition of HCT/Ps, and Beitzel and colleagues reviewed the US framework in 2015 and described PRP as exempt from the traditional approval pathway because Part 1271 treats it as a blood product. The separate same surgical procedure exception at 21 CFR 1271.15(b), which the FDA explained in its 2017 guidance, applies to HCT/Ps removed and returned to the same individual in one surgical procedure.
The FDA clears the preparation device. The FDA classification database lists product code ORG, a platelet and plasma separator for bone graft handling under 21 CFR 864.9245, Class II, defined as preparing autologous PRP from a small sample of peripheral blood for mixing with bone graft to improve handling, and product code PMQ for PRP gel for wound management. Neither code names platelet-rich fibrin, and the blood collection tubes PRF protocols use are classified at 21 CFR 862.1675 as devices to collect blood specimens prior to further testing. Beitzel and colleagues reported in 2015 that nearly all cleared systems carried the bone graft indication, so an office aesthetic use falls outside the cleared indication and is a practitioner’s off-label decision.
For exosome material the position is set out in the FDA consumer alert on regenerative medicine products, current as of April 2024, which states that there are no FDA-approved exosome products. Spain shows that this varies by country: Anitua, Prado and Orive reported in 2015 that the Spanish medicines agency had begun regulating PRP as a medicinal product.
| Item | US status | Source |
|---|---|---|
| PRP or PRF prepared at the point of care | Neither approved nor cleared; described as a blood product outside Part 1271 | 21 CFR 1271.3(d)(2); Beitzel 2015 |
| PRP preparation systems | Cleared by 510(k), Class II; typical indication is mixing with bone graft; no product code names PRF | FDA product codes ORG and PMQ; 21 CFR 864.9245 |
| Blood collection tubes, including silica-coated plastic | Class II devices to collect blood specimens prior to further testing | 21 CFR 862.1675; Tsujino 2019 |
| Exosome material | No FDA-approved product for any use | FDA consumer alert, 2024 |
A supplier’s own statements define its intended use
Under 21 CFR 801.4, a device’s intended use is shown by its labeling, its advertising and the oral or written statements of the firm and its representatives, so a supplier’s own words define what it is offering. The FDA’s January 2025 guidance on communications about unapproved uses describes how a firm may share published scientific information with health care providers, and states that it is not for current implementation pending OMB review.
- A supplier may share published, attributed research such as the studies in this review, a device’s cleared indication and its 510(k) number, and the documentation that comes with a lot.
- A supplier may not describe a kit, a centrifuge or exosome material as suited to an uncleared or unapproved use, state or imply a clinical outcome, or present a study condition as an indication for its product.
- Clinical choices, including preparation, combination, route and patient selection, belong to the licensed practitioner.
Documentation requirements for each preparation
Murray and colleagues developed the MIBO checklist in 2017 by Delphi consensus at the American Academy of Orthopaedic Surgeons and American Orthopaedic Society for Sports Medicine meetings, and its 23 PRP statements form a society-backed reporting standard. The list below adapts it, with the Miron 2019 force parameters, into what a practice records each time.
- The family by the Dohan Ehrenfest scheme: pure or leukocyte-rich, plasma or fibrin
- Device and kit name, 510(k) number and cleared indication, and the kit and tube lot numbers
- Tube material and coating, glass or silica-coated plastic, and whether the tube is labeled for this use
- Anticoagulant type and volume, or none
- Centrifuge model, rotor type (horizontal or fixed-angle), rotor radius, relative centrifugal force at the clot and spin time
- Platelet and leukocyte concentration relative to baseline, measured if possible
- Activation method, the time from draw to spin and from spin to application
- For exosome material: product name, lot number, certificate of analysis on file where requested, storage temperature log, and the time from thaw to application
A preparation specified to that list can be reproduced, compared with the published trials and audited. ExaVeyra Sciences does not supply PRP or PRF kits or centrifuges. For the exosome material it supplies, the lot number and storage requirements travel with each order, and the certificate of analysis for a lot is available on request, so that a practice can file them against the record above.
The field is moving in a useful direction. Horizontal centrifugation, reporting standards and registered head-to-head trials are making platelet concentrates easier to compare each year, and the practices that record their preparations precisely will be the ones best placed to read the next generation of trials against their own work.
Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It reviews published research and registered trials; 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. Conditions named in this article are named as the subjects of the studies cited. Naming a condition studied in a model or a trial does not establish an indication for any product. Exosome material is supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Any use of research-grade material in human subjects requires the applicable FDA pathway, such as an investigational new drug application, and institutional review board oversight. 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. Discussion of a compound’s literature, including compounds the FDA placed in category 2 of its 503A bulk drug substances policy, is not an offer to supply it. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, study design decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited, and a citation establishes that a question was studied rather than that a product suits a given patient or protocol. 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.
Peer-Reviewed References
- 1.Sollitto CF, Narduzzi M, Wolinsky C. A Systematic Review of Platelet-Rich Plasma Versus Platelet-Rich Fibrin for Periorbital Rejuvenation. J Cosmet Dermatol. 2025;24(11):e70524. PMID 41190633. doi:10.1111/jocd.70524Systematic review (PRISMA); 14 studies of PRP or PRF in the periorbital region. Carries in this article: the under-eye comparison; the review found neither superior and PRF gains often diminished by 6 months.
- 2.Qin N, Kochheiser M, Akosman I, Dugue D, Raghunandan A, Pavuluri C, et al. Systematic Review of Platelet-Rich Plasma and Platelet-Rich Fibrin in Facial Rejuvenation. Ann Plast Surg. 2025;94(4S Suppl 2):S376-S389. PMID 40167104. doi:10.1097/SAP.0000000000004267Systematic review; 20 studies (controlled trials, cohorts, case series) of PRP or PRF monotherapy for facial aging, 514 patients. Carries in this article: skin thickness (80 percent of studies) and elasticity (75 percent) improved most consistently; wrinkles 40 percent, texture 33 percent, dyschromia 17 percent, hydration 0 percent. Disclosure: declared: none.
- 3.Li M, Bai Y, Ye Z, Zhang D, He Z, Ge Z, et al. Comparative efficacy and safety of platelet-rich plasma (PRP), injectable platelet-rich fibrin (i-PRF) and concentrated growth factors (CGF) for female pattern hair loss (FPHL): a prospective multicenter randomized clinical trial. J Dermatolog Treat. 2026;37(1):2659498. PMID 42041234. doi:10.1080/09546634.2026.2659498Prospective multicenter randomized trial, three arms, 4 sessions at 4-week intervals; women with female pattern hair loss as the study subjects (Sinclair II to III); n = 74 completers; primary endpoint at 24 weeks. Carries in this article: the head-to-head hair comparison; i-PRF and CGF ahead of PRP on hair count, equal on diameter.
- 4.Hurley ET, Lim Fat D, Moran CJ, Mullett H. The Efficacy of Platelet-Rich Plasma and Platelet-Rich Fibrin in Arthroscopic Rotator Cuff Repair: A Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2019;47(3):753-761. PMID 29466688. doi:10.1177/0363546517751397Meta-analysis of 18 RCTs, 1,147 patients undergoing arthroscopic rotator cuff repair, PRP or PRF vs control. Carries in this article: the authors reported incomplete tendon healing in 17.2 vs 30.5 percent with PRP, and for PRF 23.0 vs 24.6 percent (P = .74) and a longer operation time.
- 5.Li Y, Li T, Li J, Tang X, Li R, Xiong Y. Platelet-Rich Plasma Has Better Results for Retear Rate, Pain, and Outcome Than Platelet-Rich Fibrin After Rotator Cuff Repair: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2022;38(2):539-550. PMID 34052384. doi:10.1016/j.arthro.2021.05.023Systematic review and meta-analysis of 23 RCTs, 1,440 patients. Carries in this article: retear 15.9 vs 29.0 percent with PRP; PRF changed only the Constant score (80.1 vs 80.0).
- 6.Peng Y, Du L, Yang B, Fan D, Jia S, Zheng C. Efficacy of platelet-rich plasma and platelet-rich fibrin in arthroscopic rotator cuff repair: A systematic review and meta-analysis. PM R. 2023;15(12):1643-1653. PMID 37526570. doi:10.1002/pmrj.13049Systematic review and meta-analysis of 10 RCTs, 628 patients. Carries in this article: an independent third pooled analysis in the same direction (PRP retear risk ratio 0.40; PRF no effect on retear, P = .92); the authors noted that function-score differences were below the minimum clinically important difference.
- 7.Proffer SL, Wyles SP, Hausauer AK. Update on Platelet-Rich Plasma and Platelet-Rich Fibrin for Dermatologic Surgery: Addressing Knowns and Unknowns. Dermatol Surg. 2024;50(11S):S149-S159. PMID 39480038. doi:10.1097/DSS.0000000000004421Literature review in the American Society for Dermatologic Surgery journal, weighted to level 1A to 2A evidence from 2022 to 2024. Carries in this article: dermatologic-surgery view that the absence of expert consensus and standardized protocols limits acceptance of PRP and PRF.
- 8.Estupiñan B, Ly K, Goldberg DJ. Adipose Mesenchymal Stem Cell-Derived Exosomes Versus Platelet-Rich Plasma Treatment for Photoaged Facial Skin: An Investigator-Blinded, Split-Face, Non-Inferiority Trial. J Cosmet Dermatol. 2025;24(5):e70208. PMID 40414798. PMC12104007. doi:10.1111/jocd.70208Investigator-blinded, non-randomized split-face trial; 15 adults with mild to moderate photoaging enrolled (one withdrew), three radiofrequency microneedling sessions 4 weeks apart, PRP applied to one side and topical exosome material to the other; photographs and biopsies to 6 months. Carries in this article: the only published head-to-head comparison of exosome material and PRP for facial skin found (the authors cite an earlier hair case series); the authors reported equal improvement and no histological difference, without statistical testing of the clinical scores because of the sample size, and with biopsies in the first 10 participants. The exosome product was an adipose stem cell derived product from the study sponsor, not material ExaVeyra supplies. Disclosure: supported in part by a research grant from the company that makes the exosome product and the microneedling device used.
- 9.Diab NAF, Ibrahim AM, Abdallah AM. Fluid Platelet-Rich Fibrin (PRF) Versus Platelet-Rich Plasma (PRP) in the Treatment of Atrophic Acne Scars: A Comparative Study. Arch Dermatol Res. 2023;315(5):1249-1255. PMID 36520210. PMC10205840. doi:10.1007/s00403-022-02511-3Comparative study, two groups of 15 with intra-patient split-face comparison of intradermal application alone vs combined with needling; 4 sessions at 3-week intervals; n = 30. Carries in this article: the authors reported a higher response with fluid PRF than PRP on quartile grading and satisfaction. Disclosure: declared: none.
- 10.Ahmed AEM, Mahmoud WA, El-Komy FBY. Microneedling with autologous platelet rich fibrin versus microneedling with autologous platelet rich plasma in treatment of abdominal stretch marks: a randomized comparative study. Arch Dermatol Res. 2025;317(1):602. PMID 40106114. doi:10.1007/s00403-025-04135-9Randomized split-abdomen comparison with blinded photographic evaluation and biopsies; 3 monthly sessions; n = 30. Carries in this article: microneedling followed by PRF or PRP; both sides improved and the authors found no statistically significant difference between them on any scored endpoint, while describing PRF as superior overall and reporting higher patient satisfaction with it. Disclosure: declared: none.
- 11.Farshidfar N, Amiri MA, Estrin NE, Ahmad P, Sculean A, Zhang Y, et al. Platelet-rich plasma (PRP) versus injectable platelet-rich fibrin (i-PRF): A systematic review across all fields of medicine. Periodontol 2000. 2025;99(1):185-215. PMID 40125556. doi:10.1111/prd.12626Systematic review across all fields (in vitro, in vivo, clinical); 23 studies comparing PRP with i-PRF. The authors reported i-PRF favored in 72 percent of comparisons and no difference in 24 percent. Carries in this article: broad PRP vs i-PRF comparison; interpret with the declared COI. Disclosure: declared: R.J. Miron founded Miron Research and Development in Dentistry LLC, which holds intellectual property on PRF production.
- 12.Davies C, Miron RJ. Autolougous [sic] platelet concentrates in esthetic medicine. Periodontol 2000. 2025;97(1):363-419. PMID 39086171. PMC11808453. doi:10.1111/prd.12582Narrative review built on a systematic search of RCTs to October 2023; 96 articles on PRP, PRGF and PRF in facial esthetics and dermatology. Carries in this article: the authors reported that only a few studies compared PRP with PRF directly, and named small samples and unstandardized assessment as limits. Disclosure: declared: R.J. Miron is the founder of a PRF company; both authors list a PRF education affiliation.
- 13.Hu S, Bassiri-Tehrani M, Abraham MT. The Effect of Platelet-Rich Fibrin Matrix on Skin Rejuvenation: A Split-Face Comparison. Aesthet Surg J. 2021;41(7):747-758. PMID 32816021. doi:10.1093/asj/sjaa244Randomized, placebo-controlled split-face trial (PRFM vs saline); n = 30; VISIA analysis at 6 and 12 weeks. Carries in this article: total skin score and texture differed from saline at 6 weeks (P = .003) but not at 12 weeks (P = .34); a short durability window. No COI statement in the PubMed record.
- 14.Evans AG, Ivanic MG, Botros MA, Pope RW, Halle BR, Glassman GE, et al. Rejuvenating the periorbital area using platelet-rich plasma: a systematic review and meta-analysis. Arch Dermatol Res. 2021;313(9):711-727. PMID 33433716. doi:10.1007/s00403-020-02173-zPRISMA systematic review and meta-analysis (PROSPERO CRD42019135968); 19 studies, 455 patients; meta-analysis of satisfaction in 3 RCTs; mean follow-up 3 months. Carries in this article: PRP-only periorbital evidence and the authors' call for long-term follow-up and trials free of industry sponsorship.
- 15.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, from the Italian National Blood Centre; 27 controlled trials, 1,117 subjects. Carries in this article: PRP vs saline hair density difference of 25.6 hairs per cm2, rated low-certainty evidence by the authors. Disclosure: declared: none.
- 16.Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012;40(6):1234-41. PMID 22495146. doi:10.1177/0363546512442924Blinded randomized controlled trial, level 2; arthroscopic rotator cuff repair with PRFM at the tendon-bone interface vs standard repair; n = 79; ultrasound at 6 and 12 weeks, minimum 1-year follow-up. Carries in this article: no overall difference in tendon-to-bone outcome (67 vs 81 percent intact, P = .20); in regression PRFM predicted a 12-week defect (odds ratio 5.8).
- 17.Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017;23(1):83-99. PMID 27672729. doi:10.1089/ten.TEB.2016.0233Systematic review (in vitro, in vivo, clinical); 48 publications on PRF for soft tissue regeneration, 31 clinical, 8 randomized. Carries in this article: soft tissue evidence for PRF, mostly dental; interpret with COI. Disclosure: no COI statement in the PubMed record. Authors include R.J. Miron (PRF IP holder, declared in PMID 40125556) and J. Choukroun (owner of PROCESS, declared in PMID 28283682).
- 18.Miron RJ, Gruber R, Farshidfar N, Sculean A, Zhang Y. Ten years of injectable platelet-rich fibrin. Periodontol 2000. 2024;94(1):92-113. PMID 38037213. doi:10.1111/prd.12538Narrative review of i-PRF protocols and uses since 2014. Carries in this article: i-PRF development history and the authors' proposal of i-PRF as a carrier for biomolecules including exosomes, named as a future direction rather than a tested use. Disclosure: no COI statement in the PubMed record; R.J. Miron declared PRF intellectual property in PMID 40125556.
- 19.Gupta AK, Wang T, Rapaport JA, Talukder M. Therapeutic Potential of Extracellular Vesicles (Exosomes) Derived From Platelet-Rich Plasma: A Literature Review. J Cosmet Dermatol. 2025;24(2):e16709. PMID 39618056. PMC11845942. doi:10.1111/jocd.16709Literature review (Embase, Web of Science, ClinicalTrials.gov, June 2024). Carries in this article: PRP itself is a rich source of extracellular vesicles; the review found preclinical wound-model data and scarce information for hair and skin rejuvenation, with isolation and activation methods not yet optimized. Disclosure: declared: none.
- 20.Harrison P, Subcommittee on Platelet Physiology. The use of platelets in regenerative medicine and proposal for a new classification system: guidance from the SSC of the ISTH. J Thromb Haemost. 2018;16(9):1895-1900. PMID 30099839. doi:10.1111/jth.14223Expert consensus (RAND method), ISTH SSC guidance; 45 statements scored by the working party. Carries in this article: haematology-society view that controlled trials were few and preparations poorly defined, too few for evidence-based guidelines.
- 21.Murray IR, Geeslin AG, Goudie EB, Petrigliano FA, LaPrade RF. Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO): Platelet-Rich Plasma and Mesenchymal Stem Cells. J Bone Joint Surg Am. 2017;99(10):809-819. PMID 28509821. doi:10.2106/JBJS.16.00793Delphi consensus from the AAOS/ORS and AOSSM symposia; 23 PRP experts, three survey rounds, 58 items compiled into a 23-statement PRP checklist. Carries in this article: the society-backed minimum reporting checklist behind the documentation section.
- 22.Chahla J, Cinque ME, Piuzzi NS, Mannava S, Geeslin AG, Murray IR, et al. A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. J Bone Joint Surg Am. 2017;99(20):1769-1779. PMID 29040132. doi:10.2106/JBJS.16.01374Systematic review of 105 clinical PRP studies, 2006 to 2016. Carries in this article: only 10 percent described a reproducible preparation protocol and 16 percent reported the composition of the final product.
- 23.DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy. 2012;28(7):998-1009. PMID 22738751. doi:10.1016/j.arthro.2012.04.148Classification proposal (narrative); published PRP protocols in orthopaedics. Carries in this article: PAW classification (platelet number, activation, white cells).
- 24.Magalon J, Chateau AL, Bertrand B, Louis ML, Silvestre A, Giraudo L, et al. DEPA classification: a proposal for standardising PRP use and a retrospective application of available devices. BMJ Open Sport Exerc Med. 2016;2(1):e000060. PMID 27900152. doi:10.1136/bmjsem-2015-000060Classification proposal with retrospective application to 20 published PRP preparations from commercial devices. Carries in this article: DEPA classification; platelet amount ranged 0.21 to 5.43 billion, a 25-fold spread, and no device recovered more than 90 percent of blood platelets.
- 25.Lana JFSD, Purita J, Paulus C, Huber SC, Rodrigues BL, Rodrigues AA, et al. Contributions for classification of platelet rich plasma - proposal of a new classification: MARSPILL. Regen Med. 2017;12(5):565-574. PMID 28758836. doi:10.2217/rme-2017-0042Classification proposal (narrative); PRP cellular and molecular components. Carries in this article: MARSPILL classification (method, activation, red cells, spins, image guidance, leukocytes, light activation).
- 26.Miron RJ, Pinto NR, Quirynen M, Ghanaati S. Standardization of relative centrifugal forces in studies related to platelet-rich fibrin. J Periodontol. 2019;90(8):817-820. PMID 30730050. doi:10.1002/JPER.18-0553Editorial and reporting standard for PRF research. Carries in this article: RCF vs rpm reporting and the six parameters a reproducible method states. Disclosure: no COI statement in the PubMed record. Co-authors include R.J. Miron (PRF IP holder, declared in PMID 40125556).
- 27.Choukroun J, Ghanaati S. Reduction of relative centrifugation force within injectable platelet-rich-fibrin (PRF) concentrates advances patients’ own inflammatory cells, platelets and growth factors: the first introduction to the low speed centrifugation concept. Eur J Trauma Emerg Surg. 2018;44(1):87-95. PMID 28283682. doi:10.1007/s00068-017-0767-9In vitro laboratory study; peripheral blood from 6 healthy volunteers, liquid PRF at RCF 710, 177 and 44 g at constant time. Carries in this article: primary description of the low-speed centrifugation concept. Disclosure: declared: J. Choukroun is the owner of PROCESS (PRF centrifuge and protocol supplier).
- 28.Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, et al. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014;40(6):679-89. PMID 24945603. doi:10.1563/aaid-joi-D-14-00138In vitro histological comparison; clots from 4 human donors, S-PRF (2700 rpm, 12 min) vs A-PRF (1500 rpm, 14 min). Carries in this article: original A-PRF description. Disclosure: co-author J. Choukroun is the owner of PROCESS, a supplier of PRF centrifuges and protocols; declared in PMIDs 28283682 and 28324162, not in this record.
- 29.Miron RJ, Chai J, Zheng S, Feng M, Sculean A, Zhang Y. A novel method for evaluating and quantifying cell types in platelet rich fibrin and an introduction to horizontal centrifugation. J Biomed Mater Res A. 2019;107(10):2257-2271. PMID 31148358. doi:10.1002/jbm.a.36734In vitro laboratory study (sequential 1 mL layer CBC analysis); venous blood processed on fixed-angle and horizontal centrifuges. Carries in this article: horizontal rotors yielded up to 3.5-fold more platelets and leukocytes. Disclosure: no COI statement in the PubMed record. Senior author R.J. Miron later declared PRF intellectual property (PMID 40125556).
- 30.Fujioka-Kobayashi M, Kono M, Katagiri H, Schaller B, Zhang Y, Sculean A, et al. Histological comparison of Platelet rich fibrin clots prepared by fixed-angle versus horizontal centrifugation. Platelets. 2021;32(3):413-419. PMID 32306811. doi:10.1080/09537104.2020.1754382In vitro SEM and histology comparison; PRF clots, fixed-angle (about 400 g at the clot, 12 min) vs horizontal (700 g RCF-max, 8 min). Carries in this article: rotor geometry and cell distribution in PRF. Disclosure: no COI statement in the PubMed record; senior author R.J. Miron later declared PRF intellectual property (PMID 40125556).
- 31.Tsujino T, Takahashi A, Yamaguchi S, Watanabe T, Isobe K, Kitamura Y, et al. Evidence for Contamination of Silica Microparticles in Advanced Platelet-Rich Fibrin Matrices Prepared Using Silica-Coated Plastic Tubes. Biomedicines. 2019;7(2):45. PMID 31248187. PMC6631693. doi:10.3390/biomedicines7020045In vitro laboratory study (SEM, spectrophotometry); A-PRF-like matrices from three brands of silica-coated plastic tubes. Carries in this article: tube surface chemistry as a preparation variable; most such tubes are approved for diagnostic use only. Disclosure: declared: none.
- 32.Ulasli AM, Ozturk GT, Cakir B, Celik GE, Bakir F. The effect of the anticoagulant on the cellular composition and growth factor content of platelet-rich plasma. Cell Tissue Bank. 2022;23(2):375-383. PMID 34455526. doi:10.1007/s10561-021-09952-6Laboratory comparative study; 12 healthy participants, PRP with 0.9 mL or 0.5 mL 3.8% sodium citrate, or none. Carries in this article: citrate raised platelet capture, PDGF and TGF-beta1; omitting it gave the most leukocytes and VEGF.
- 33.Fitzpatrick J, Bulsara MK, McCrory PR, Richardson MD, Zheng MH. Analysis of Platelet-Rich Plasma Extraction: Variations in Platelet and Blood Components Between 4 Common Commercial Kits. Orthop J Sports Med. 2017;5(1):2325967116675272. PMID 28210651. doi:10.1177/2325967116675272Controlled laboratory study; whole blood from 3 healthy adults processed through 4 commercial PRP kits. Carries in this article: buffy-coat kits concentrated platelets 3 to 6 times baseline, a plasma-sampling kit 1.5 times. Disclosure: declared: the kits were supplied by their manufacturers.
- 34.Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009;27(3):158-67. PMID 19187989. doi:10.1016/j.tibtech.2008.11.009Narrative review and classification proposal; published platelet concentrate systems. Carries in this article: origin of the P-PRP, L-PRP, P-PRF and L-PRF families (pre-2011 landmark).
- 35.Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun’s platelet-rich fibrin clot and membrane. J Periodontol. 2010;81(4):546-55. PMID 20373539. doi:10.1902/jop.2009.090531In vitro microscopy study (light and SEM); L-PRF clots and membranes from 10 mL blood; dry glass vs glass-coated plastic tubes. Carries in this article: about 97 percent of platelets and more than half of leukocytes captured in the clot (pre-2011 landmark).
- 36.Kobayashi E, Flückiger L, Fujioka-Kobayashi M, Sawada K, Sculean A, Schaller B, et al. Comparative release of growth factors from PRP, PRF, and advanced-PRF. Clin Oral Investig. 2016;20(9):2353-2360. PMID 26809431. doi:10.1007/s00784-016-1719-1In vitro release kinetics study (ELISA at 15 min, 60 min, 8 h, 1, 3 and 10 days); 18 samples from 6 donors. Carries in this article: early release higher from PRP, later and total release highest from A-PRF. Disclosure: no COI statement in the PubMed record; senior author R.J. Miron later declared PRF intellectual property (PMID 40125556).
- 37.Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, et al. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016;2(1):19. PMID 27747711. PMC5005757. doi:10.1186/s40729-016-0052-4In vitro comparative study; PRP, PRGF, A-PRF and CGF from the same healthy donors. Carries in this article: comparable or higher growth-factor content in A-PRF and CGF than PRP, from an independent group.
- 38.Fujioka-Kobayashi M, Miron RJ, Hernandez M, Kandalam U, Zhang Y, Choukroun J. Optimized Platelet-Rich Fibrin With the Low-Speed Concept: Growth Factor Release, Biocompatibility, and Cellular Response. J Periodontol. 2017;88(1):112-121. PMID 27587367. doi:10.1902/jop.2016.160443In vitro study (release to 10 days, fibroblast assays); L-PRF vs A-PRF vs A-PRF+. Carries in this article: lower speed and shorter time increased release. Disclosure: no COI statement in the PubMed record; R.J. Miron (PMID 40125556) and J. Choukroun (PMID 28283682) later declared PRF interests. A published letter (PMID 29999526) disputed the RCF reporting in this paper.
- 39.Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, et al. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017;21(8):2619-2627. PMID 28154995. doi:10.1007/s00784-017-2063-9In vitro study (release to 10 days, fibroblast assays); standard PRP vs i-PRF (60 g, 3 min); 8 donor samples. Carries in this article: PRP higher early; i-PRF higher 10-day PDGF-AA, PDGF-AB, EGF and IGF-1; PRP higher 10-day TGF-beta1 and VEGF. Disclosure: no COI statement in the PubMed record; R.J. Miron later declared PRF intellectual property (PMID 40125556).
- 40.El Bagdadi K, Kubesch A, Yu X, Al-Maawi S, Orlowska A, Dias A, et al. Reduction of relative centrifugal forces increases growth factor release within solid platelet-rich-fibrin (PRF)-based matrices: a proof of concept of LSCC (low speed centrifugation concept). Eur J Trauma Emerg Surg. 2019;45(3):467-479. PMID 28324162. PMC6579868. doi:10.1007/s00068-017-0785-7In vitro study (immunohistochemistry, ELISA to 10 days); PRF vs A-PRF vs A-PRF+ solid matrices. Carries in this article: lower RCF increased VEGF, TGF-beta1 and EGF release in solid PRF. Disclosure: declared: J. Choukroun is the owner of PROCESS (PRF centrifuge and protocol supplier).
- 41.Beitzel K, Allen D, Apostolakos J, Russell RP, McCarthy MB, Gallo GJ, et al. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine. J Knee Surg. 2015;28(1):29-34. PMID 25268794. doi:10.1055/s-0034-1390030Regulatory review. Carries in this article: PRP preparation systems reach market through 510(k); nearly all were cleared for mixing with bone graft to improve handling, and other uses are off-label; the CBER language on practitioner responsibility and record keeping.
- 42.Anitua E, Prado R, Orive G. Closing regulatory gaps: new ground rules for platelet-rich plasma. Trends Biotechnol. 2015;33(9):492-5. PMID 26319248. doi:10.1016/j.tibtech.2015.07.002Commentary and regulatory analysis; Spanish AEMPS resolution regulating PRP as a medicinal product. Carries in this article: non-US contrast; PRP regulation is jurisdiction-specific. Disclosure: no COI statement in the PubMed record. All authors list affiliation with BTI Biotechnology Institute, developer of a PRGF platelet system.
- 43.U.S. Food and Drug Administration. 21 CFR 1271.3(d), definition of human cells, tissues, or cellular or tissue-based products (HCT/Ps), including paragraph (d)(2), which excludes whole blood, blood components and blood derivative products. eCFR, accessed October 2026: ecfr.gov/current/title-21/section-1271.3; FDA CFR database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.3Federal regulation. Carries in this article: platelet concentrates are blood components, which the HCT/P definition excludes; the regulatory position of PRP and PRF follows the device and the practice of medicine.
- 44.U.S. Food and Drug Administration. 21 CFR 1271.15(b), the same surgical procedure exception. eCFR, accessed October 2026: ecfr.gov/current/title-21/section-1271.15; FDA CFR database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.15Federal regulation. Carries in this article: an establishment that removes HCT/Ps from an individual and implants them into the same individual in the same surgical procedure is not required to comply with Part 1271.
- 45.U.S. Food and Drug Administration. Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception. Guidance for Industry, November 2017 (Docket FDA-2014-D-1584). fda.gov/regulatory-information/search-fda-guidance-documents/same-surgical-procedure-exception-under-21-cfr-127115b-questions-and-answers-regarding-scopeFinal FDA guidance. Carries in this article: how narrowly the agency reads the same surgical procedure exception.
- 46.U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. Guidance for Industry and FDA Staff, July 2020, superseding the November 2017 version as corrected December 2017 (Docket FDA-2017-D-6146). fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimalFinal FDA guidance. Carries in this article: the minimal manipulation and homologous use criteria that decide whether a cell or tissue product needs premarket approval.
- 47.U.S. Food and Drug Administration. Product Classification database, product code ORG: platelet and plasma separator for bone graft handling; 21 CFR 864.9245 (automated blood cell separator), Class II, 510(k). Verified through the openFDA device classification API, October 2026. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=ORGFDA device classification entry. Carries in this article: the classification definition reads preparation of autologous PRP from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
- 48.U.S. Food and Drug Administration. Product Classification database, product code PMQ: peripheral blood processing device for wound management; 21 CFR 864.9245, Class II, 510(k). Verified through the openFDA device classification API, October 2026. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=PMQFDA device classification entry. Carries in this article: a second platelet-preparation product code, defined as preparation of autologous PRP gel for wound management; neither code describes an aesthetic use.
- 49.U.S. Food and Drug Administration. 21 CFR 801.4, meaning of intended uses. eCFR, accessed October 2026: ecfr.gov/current/title-21/section-801.4; FDA CFR database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.4Federal regulation. Carries in this article: a device's intended use is shown by labeling claims, advertising matter and oral or written statements, which is why a supplier's own words define what it is offering.
- 50.U.S. Food and Drug Administration. Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. Final Guidance for Industry, January 2025 (Docket FDA-2008-D-0053). fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-usesFinal FDA guidance. Carries in this article: the agency's enforcement policy for firms sharing published scientific information on unapproved uses with health care providers; the guidance states it is not for current implementation pending OMB review.
- 51.U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. Content current as of April 2024. fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomesFDA consumer communication. Carries in this article: the agency's statement that there are no FDA-approved exosome products, relevant to every exosome search question this article answers.
- 54.U.S. Food and Drug Administration. 21 CFR 862.1675, blood specimen collection device. eCFR, accessed October 2026: ecfr.gov/current/title-21/section-862.1675; FDA CFR database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=862.1675Federal regulation, Class II. Carries in this article: blood collection tubes are classified as devices to collect and handle blood specimens and separate serum from cellular components prior to further testing, which is the classification of the tubes PRF protocols use.
- 52.Zagazig University. Split-Side Comparative Clinical Study of Platelet-Rich Fibrin Versus Platelet-Rich Plasma With or Without Microneedling in Treatment of Striae Distensae. ClinicalTrials.gov NCT07561671. Start February 2024, completed February 2026. clinicaltrials.gov/study/NCT07561671Registered randomized, double-masked trial (participant and outcomes assessor; the registry lists a parallel intervention model although the title says split-side); 30 participants enrolled; PRF or PRP applied intradermally or topically after microneedling. Status verified on ClinicalTrials.gov, October 2026: completed, no results posted. Carries in this article: a registered head-to-head comparison awaiting publication.
- 53.Services Hospital, Lahore. Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia. ClinicalTrials.gov NCT06239207. Start September 2023, completed July 2024. clinicaltrials.gov/study/NCT06239207Registered randomized open-label comparison; 30 participants; androgenetic alopecia as the study subject; primary endpoint a greater than 25 percent increase in hair density 6 months after the last session. Status verified on ClinicalTrials.gov, October 2026: completed, no results posted. Carries in this article: the registered exosome vs PRP comparison in hair research.
- 55.Froum S, Estrin NE, Ahmad P, Farshidfar N, Miron RJ. The Feasibility of Exosome-Enriched Platelet-rich Fibrin (PRF) for the Treatment of Gingival Recessions: A Case Series of 27 Patients. Oral Health Prev Dent. 2026;24:51-60. PMID 41603870. PMC12852986. doi:10.3290/j.ohpd.c_2394Uncontrolled case series; 27 dental patients (125 teeth); PRF hydrated with exosomes before surgical application; 6-month follow-up. Carries in this article: exosome material has been combined with PRF in dental case series, without a control group; the authors call for controlled studies. Disclosure: authors include the PRF research group whose intellectual property and supplier interests are noted at entry 12.
- 56.Froum S, Estrin NE, Cho HJ, Farshidfar N, Ahmad P, Miron RJ. Treatment of Severe Periodontitis using Exosome-Mediated Combination Therapies: A Retrospective Cohort Study. Oral Health Prev Dent. 2026;24:489-497. PMID 42374783. PMC13316740. doi:10.3290/j.ohpd.c_2745Retrospective case series without a comparator; 13 patients, 23 periodontal defects; exosomes with bone graft and horizontal PRF; 6 months. Carries in this article: a second uncontrolled dental report of exosome material with PRF; the authors state that controlled trials with comparator groups are needed. Disclosure: same research group as entry 55.