Nature Group · 2024A1
Clinical applications of stem cell-derived exosomes
Signal Transduction and Targeted Therapy · Nature Publishing Group
MSC exosomestissue regenerationimmunomodulationsurgical applications
✓ Open Access · CC BY 4.0
The Science of Regenerative Medicine
ExaVeyra supplies characterized biomolecular signaling vesicles (exosomes), manufactured under cGMP, for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research, along with compounded preparations dispensed by our 503A pharmacy partner on a patient-specific prescription. Our catalog is grounded in the peer-reviewed literature from 2018 to 2025.
cGMP Manufacturing Standard
Exosome material supplied by ExaVeyra is manufactured by Kimera Labs under cGMP. Compounded preparations are prepared by a 503A pharmacy licensed by its state Board of Pharmacy, against a valid prescription for an individual patient. Every lot ships with full documentation.
Licensed 503A Pharmacy Partner
Our 503A pharmacy partner is licensed by its state Board of Pharmacy. ExaVeyra does not work with a 503B outsourcing facility.
Full COA for Every Lot, on Request
Nanoparticle tracking, protein quantification, sterility, and endotoxin
Cold-Chain Shipping
Exosome material ships frozen on dry ice and is stored at −20°C long term and 4°C once thawed, per the manufacturer's handling instructions
Investigator Support
For sponsor-held IND studies, exosome material and lot documentation are available subject to the manufacturer's authorization, with the manufacturer's chemistry, manufacturing and controls information on request. ExaVeyra does not sponsor or hold an IND.
Active Research Areas
The following four domains are areas of active peer-reviewed clinical research from 2019 to 2025. They summarize published literature and describe no use of any ExaVeyra product.
Research Context Only. The following summaries describe active research fields and published literature. They do not constitute efficacy claims for ExaVeyra products. Exosome material is supplied for topical aesthetic use and laboratory research. Compounded preparations are dispensed by our 503A pharmacy partner on a patient-specific prescription.
Extracellular Vesicles & Exosomes
Signaling VesiclesTopical AestheticResearch Applications
MSC-derived exosomes are biomolecular signaling vesicles that carry bioactive cargo growth factors, miRNA, and signaling proteins and are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research. A 2023 first-in-human trial assessed safety and tolerability of allogeneic platelet-derived extracellular vesicles.
- [1] J Extracell Vesicles. 2023. First-in-human allogeneic platelet-derived EV trial (Johnson J, et al.).
Dermatology & Topical Aesthetic
Topical AestheticPhotoagingClinical Research
Biomolecular signaling vesicles (exosomes) are applied topically in aesthetic practice. Adipose tissue MSC-derived exosomes combined with microneedling were evaluated in a 12-week prospective randomized split-face study vs. saline (p = 0.005, Journal of Cosmetic Dermatology, 2023). Research examines exosome effects on matrix metalloproteinase expression, type I collagen and elastin synthesis, and UV-induced senescence markers in the context of photoaging and post-procedure applications.
- [2] J Cosmet Dermatol. 2023. Adipose MSC exosome + microneedling, 12-week RCT.
- [3] Cell Commun Signal. 2024. Exosomes in skin photoaging: biological functions and therapeutic opportunity.
Hair Restoration & Trichology
Androgenetic AlopeciaTopical AestheticResearch
Exosomes as biomolecular signaling vesicles are used in topical aesthetic and research contexts. A 2024 prospective study evaluated exosome applications in androgenetic alopecia; active comparative trials are running exosomes vs. platelet-rich plasma (NCT06239207). Research examines delivery of growth factors to dermal papilla cells. A 2025 systematic review synthesizes evidence across alopecia types and exosome sources.
- [4] PubMed 39174804. Prospective study: exosomes in androgenetic alopecia, 2024.
- [5] PMC12433634. Systematic review: exosomes and hair, 2025.
Compounded Preparations
FDA-Approved AnalogsGHRH Signaling503A Compounding
FDA-approved peptide drugs such as tesamorelin show how targeted amino acid sequences act on metabolic and hormonal signaling, and GLP-1 and dual-incretin receptor agonists are studied for effects beyond glucose control. Compounded preparations are dispensed by our 503A pharmacy partner on a patient-specific prescription, and the formulary is released after NPI verification.
- [6] FDA. Egrifta SV (tesamorelin) prescribing information, 2023.
Speak With Our Compliance Team
Our team can walk you through research context, sourcing questions, and regulatory considerations. Select any areas of interest and we'll connect you with the right specialist.
Areas of Interest Check all that apply
All inquiries are reviewed by our compliance and research team. We do not share your information with third parties.
Clinical Literature Explorer
Browse 20 curated peer-reviewed studies from high-impact journals (2019 to 2025) or search 200M+ indexed publications via Semantic Scholar AI. Filter by biologic class, sort by date, impact factor, or citation count, and expand any row to read the abstract.
AI Literature SearchSemantic Scholar
Search peer-reviewed publications across regenerative biology, exosome science, and biochemical research.
Sort:
Showing 7 curated publications
| Title / Authors | Biologic Class | Journal | Design | Key Finding | |
|---|---|---|---|---|---|
Al Ameer M, Alnajim A, Al Ameer A, et al. | MSC-Derived Exosomes | Clinical, Cosmetic and Investigational Dermatology | 2025 | Systematic Review | Eleven small, mixed studies (two RCTs) all reported improvement in at least one hair measure; the strongest evidence came from adipose- and plant-derived exosome RCTs. Heterogeneous designs limit comparison. |
Gupta AK, Wang T, Welter R, et al. | Extracellular Vesicles | Medical Sciences | 2025 | Scoping Review | Across 2020 to 2025 evidence, PRP is the most studied option; stem cells and exosomes show promising but still limited evidence, and standardization is needed. |
Hajialiasgary Najafabadi A, Soheilifar MH, Masoudi-Khoram N | Extracellular Vesicles | Cell Communication and Signaling | 2024 | Narrative Review | Reviews preclinical and in vitro evidence that stem cell exosomes reduce MMP expression and increase collagen and elastin production in photoaged skin. |
Peredo M, Shivananjappa S | MSC-Derived Exosomes | Journal of Drugs in Dermatology | 2024 | Case Series (uncontrolled) | Topical placental MSC exosomes (one brand) applied after aesthetic procedures were followed by faster visible healing, assessed visually; no adverse events. Uncontrolled. |
Norouzi F, Aghajani S, Vosoughi N, et al. | MSC-Derived Exosomes | Regenerative Therapy | 2024 | Narrative Review | Reviews exosome characteristics, cellular sources and reported effects on skin aging and hair. |
Park G, Kwon HH, Seok J, et al. | MSC-Derived Exosomes | Journal of Cosmetic Dermatology | 2023 | Prospective, Randomized, Split-Face RCT | Global Aesthetic Improvement Scale scores were significantly higher on the exosome side (p = 0.005); device measurements showed greater improvement in wrinkles, elasticity, hydration and pigmentation. |
Kim J, Kim EH, Lee H, et al. | Extracellular Vesicles | International Journal of Molecular Sciences | 2023 | Preclinical and Manufacturing Study | A scalable Wharton's jelly MSC-EV production platform; the EVs improved wound recovery in rat and mouse models and acted on every stage of healing in vitro. |
AI search powered by Semantic Scholar 200M+ peer-reviewed publications indexed with ML-based relevance ranking. ExaVeyra Sciences does not claim endorsement by any author, journal, or institution listed.
Peer-Reviewed Science
All citations sourced from PubMed, PMC, and peer-reviewed journals. Links open directly to the original publication.
⚠ EDUCATIONAL DISCLAIMER
The research citations and scientific content on this page are provided for educational and informational purposes only. This content does not constitute medical advice, diagnosis, or treatment recommendations. ExaVeyra Sciences does not make clinical efficacy claims for any products. All cited publications are independently authored peer-reviewed studies available through PubMed, PMC, or DOI. Nothing in these citations is a claim about any product. Practitioners decide, within their own scope of practice, whether and how any material is used.
IND Study and Clinical Trial Supply
For sponsor-held IND studies and registered clinical trials, ExaVeyra supplies the following, subject to each manufacturer's authorization. IND registration and other study documentation may be requested before supply.
- Exosome formulations, each lot with a certificate of analysis
- Wharton's jelly material for IND studies and registered clinical trials
- Mesenchymal stem cell products from NeoScientifix, a registered tissue bank
- The manufacturer's chemistry, manufacturing and controls information, on request
- Cold-chain shipping with a temperature record for every shipment
Investigator Partnership Program
IRB-approved and IND-supported studies are eligible for dedicated account management, priority lot reservation and regulatory documentation support. ExaVeyra does not sponsor or hold an IND. Apply for the ExaVeyra Research Partnership to discuss your protocol requirements.
Science & Research FAQs
- What are exosomes and how are they used in clinics?
- Exosomes are nano-sized biomolecular signaling vesicles (30 to 150 nm). They carry a characterized cargo of growth factors, cytokines, miRNA, and signaling proteins and are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research.
- How does ExaVeyra source its exosomes and compounded preparations?
- Exosome material is manufactured by Kimera Labs under cGMP, and compounded preparations are prepared by a 503A pharmacy licensed by its state Board of Pharmacy, against a valid prescription for an individual patient. ExaVeyra does not work with a 503B outsourcing facility. All products are accompanied by full certificates of analysis (COA), lot documentation, and cold-chain shipping. For IND-supported research, we coordinate product specifications, analytical characterization, and regulatory documentation to align with your protocol requirements.
- What is the regulatory status of exosome products used in clinical research?
- Exosome and extracellular vesicle products occupy a regulatory space that depends on their intended use, manufacturing pathway, and whether they are covered under an active Investigational New Drug (IND) application. Exosome material is not a compounded drug, and no compounding pathway, 503A or 503B, applies to it. For formal clinical trials, IND application support, and GMP lot release documentation are available through our research partnerships.
- Which research areas are most active for exosome and extracellular vesicle science?
- As of 2025, the most active published research covers skin biology and photoaging, including a 12-week randomized split-face study in 2023 of topical application after microneedling, and hair follicle biology. Other areas are at preclinical or early clinical stages. ExaVeyra supplies exosomes for topical aesthetic use and laboratory research only.
- What analytical characterization do ExaVeyra exosome products include?
- ExaVeyra distributes Kimera Labs biomolecular signaling vesicles characterized by HPLC, RNA quantification assay, and NanoSight NTA, confirming exosome identity and formulation integrity. Products are cell-free topical cosmetic formulations from perinatal MSCs with no animal or human serum. Lot-specific COAs are available for all products.
- Can ExaVeyra supply material for IND studies and clinical trials?
- Yes, subject to each manufacturer's authorization. For sponsor-held IND studies and registered clinical trials, ExaVeyra supplies exosome material, Wharton's jelly material and mesenchymal stem cell products from registered tissue banks, with lot documentation. IND registration and other study documentation may be requested before supply, and ExaVeyra does not sponsor or hold an IND.
Further reading
- Exosome regulatory reference
How FDA treats exosome products, including the 361 versus 351 distinction and CMC expectations.
- Regenerative therapies overview
Where exosomes, peptides, and PRP sit alongside one another in clinical practice.
- Peptide science reference
Mechanism-level reference on the peptide classes clinics ask about, from BPC-157 and TB-500 to the growth hormone secretagogues.
- Quality and characterization
What a defensible exosome product looks like on paper: MISEV 2023, particle counting, tetraspanin panels, sterility and cold chain.
- Exosome biochemistry
Biogenesis, surface protein architecture, miRNA and protein cargo, and the properties studied in regenerative medicine research.
- Hair and scalp science
Evidence references for the components of hair and scalp protocols, from finasteride and minoxidil combinations to GHK-Cu and extracellular vesicles, with study designs labeled.
Important regulatory notice
Product status. Biomolecular signaling vesicles (exosomes) supplied by ExaVeyra Sciences are not approved, cleared, or licensed by the United States Food and Drug Administration. No exosome product has been approved by the FDA for administration to humans for any indication. Statements on this page have not been evaluated by the FDA.
Use and responsibility. Supplied for topical aesthetic use by licensed practitioners, as labeled by the manufacturer, and for laboratory and IND-authorized clinical research. Not for injection, infusion, intranasal or any other route into the body. The licensed practitioner is solely responsible for whether, how and in what setting the material is used.