Evaluation of Exosomes for Hair Loss: A Primary Preclinical Study Comparing Efficacy

Authors: Ashkan B. Hayatdavoudi MD JD, Charit Seneviratne PhD,  Craig Barton MD, Michelle Ischayek DO, Baubac Hayatdavoudi MD, The AlviArmani Research Institute

May 2025; A Primary Exploratory Ex Vivo/ In Vitro Laboratory Study

Abstract

Exosomes are a rapidly advancing frontier in regenerative medicine and aesthetic dermatology. Their use in hair restoration has garnered significant interest, particularly for patients with alopecia areata, androgenetic alopecia, or receding hairlines. This study investigates the effects of two commercial exosome formulations on human hair follicle viability and target gene expression using proprietary Microscalp Technology and PCR-based analysis. We observed significant improvements in follicular viability and gene expression in favor of one product, with clear dose-dependent manner. These findings emphasize the need for clinical-grade exosome validation and propose a new methodology for standardizing treatment protocols in regenerative hair loss therapy.

Introduction: Exosomes For Hair Loss

Microscalp Technology, developed by the AlviArmani Research Institute, is a proprietary ex vivo assay designed to evaluate the viability and biological responsiveness of human hair follicles under laboratory conditions. By simulating the follicular microenvironment, this platform enables precise assessment of biologic products such as exosomes on live tissue, offering a standardized method for screening their regenerative impact before clinical application.

Hair loss is a multifactorial condition influenced by genetics, immune response, hormonal changes, and environmental triggers. Common types of hair loss include androgenetic alopecia, alopecia areata, and telogen effluvium. Traditional treatment modalities such as minoxidil, finasteride, and hair transplant surgery offer varying levels of success and often come with limitations or side effects.

Recent advances in regenerative medicine have highlighted the use of small extracellular vesicles, particularly exosomes, as therapeutic agents in dermatologic and aesthetic applications. Derived from mesenchymal stem cells or adipose tissue, exosomes contain bioactive cargo including proteins, nucleic acids, lipids, and cytokines that facilitate cell communication and tissue repair. These properties make exosomes a compelling candidate for hair regeneration.

Several peer-reviewed clinical trials and systematic reviews have demonstrated the potential of exosomes to stimulate dermal papilla cells, activate hair follicle stem cells, enhance angiogenesis, and modulate immune activity [4,6].. the potential of exosomes to stimulate dermal papilla cells, activate hair follicle stem cells, enhance angiogenesis, and modulate immune activity. The growth factor profiles of these exosomes mimic endogenous signals involved in the hair growth cycle, particularly transitioning follicles from telogen phase to anagen. Despite the excitement surrounding exosome therapy, the commercial market remains largely unregulated, with many formulations lacking batch-specific validation [7].

This study aims to evaluate the biological activity of two leading exosome products using AlviArmani’s Microscalp Technology and gene expression assays. This approach is consistent with the broader principles of regenerative follicular biology described by Ji et al. [1], as well as institutional advancements and applied translational research frameworks detailed in AlviArmani’s published resources [2,3]. Our objective is to establish a quantifiable benchmark for exosome therapy efficacy in the treatment of hair loss and promote a standardized, evidence-based approach to their clinical use.

Methods

Human follicular units harvested from consenting hair transplant patients were cultured and exposed to each product at two concentrations (1x and 10x manufacturer-recommended doses). Controls received no exosome exposure.

Follicular viability was assessed at 72 hours using a metabolic spectrophotometer assay. To complement these results, gene expression was analyzed through real-time PCR focusing on three genes associated with angiogenesis, follicular cycling, and inflammatory modulation. These markers were chosen based on well known roles in hair follicle growth and development and previous research highlighting their upregulation during new hair growth. Gene identification is kept confidential.

How Are Exosomes Obtained for Hair Loss Therapy?

Two commercial exosome formulations were tested using Microscalp Technology, an ex vivo assay platform developed by the AlviArmani Research Institute. The exosomes were derived from mesenchymal stem cells and umbilical cord tissue, selected for their regenerative potency. Product names are confidential, and validation was performed independently of manufacturer claims.

Results

Figure 1: Microscalp Viability Assay Results

Follicle Viability Assay Demonstrating Efficacy of Exosomes For Hair Loss

This bar graph displays the viability percentage of human hair follicles after exposure to two commercial exosome formulations at 1x and 10x concentrations. Product A outperformed Product B, particularly at the 1x concentration.

Microscalp Viability Assay:

  • Product A increased follicular viability by 15% at 1x concentration and 8% at 10x.
  • Product B demonstrated viability increases of 13% (1x) and 10% (10x).
  • Both products outperformed the untreated control.
  • The two products were not statistically significant in their outcomes compared to each other.

Figure 2: Gene Expression Changes in Response to Exosome Exposure

Gene Expression PCR Evaluating Exosomes For Hair Loss

This figure illustrates the relative changes in gene expression levels of the three genes involved in follicular regeneration following treatment with exosomes at two different concentrations assayed with real-time qPCR. Concentration B demonstrated the most consistent and elevated gene activation across all markers tested.

Gene Expression Testing:

  • Concentration B induced the greatest upregulation across all gene targets.
  • Concentration A showed more variable outcomes, with gene 2 with notably decreased activation relative to higher dose.
  • Key pathways included vascular regeneration, immune modulation, follicular cycling, DPC migration and structural protein synthesis.

Figure 3: Before and After Clinical Result from Exosome Therapy

Exosomes For Hair Loss Before and After Results

This clinical image illustrates the visual impact of exosome therapy after three months. The patient exhibited measurable improvements in scalp coverage and hair shaft thickness. Outcomes are consistent with molecular and cellular findings, highlighting the regenerative effects of well-validated exosomes [8].

Discussion

Clinical Relevance

Hair loss significantly impacts patient quality of life, particularly when onset occurs early or progresses rapidly. Traditional therapies are not universally effective and may produce systemic or topical side effects. The findings in this study reinforce the therapeutic promise of exosomes as minimally invasive, biologically compatible treatments capable of producing localized regenerative effects without systemic complications [5]. These agents can serve as both standalone and adjunct treatments in comprehensive hair loss treatments.

Mechanistic Insights

The molecular mechanisms underpinning hair regrowth involve complex interactions between follicle stem cells, dermal papillae, vascular endothelium, and immune cells. Exosomes have been shown to participate in intercellular communication by transporting nucleic acids, microRNA, and proteins that mimic the body’s natural repair signals. Our PCR data supports this model, demonstrating gene activation patterns associated with extracellular matrix remodeling, angiogenesis, and inflammatory regulation.

Product and Dose Variability

This study revealed clear differences in efficacy between products and concentrations. Higher concentrations did not yield proportionally greater biological activity, possibly due to receptor saturation or feedback inhibition. This suggests the need for precise dose optimization in clinical practice. Furthermore, Concentration B’s superior performance at lower concentration highlights the importance of assessing product potency rather than relying solely on label concentration.

Limitations and Future Directions

This study was limited to in vitro analysis. While the results provide strong biological rationale, in vivo trials are necessary to confirm long-term effects on thicker hair, hair shaft thickness, and sustainability of new hair. Future studies should include biopsy-based histological analysis and extended follow-up periods to capture dynamic changes in follicular cycling. Additionally, combination protocols using PRP or microneedling alongside exosomes may enhance outcomes and warrant investigation [2].

Standardization and Regulatory Implications

The unregulated exosome landscape presents risks to both patients and providers. Standardized assays like Microscalp Technology can serve as tools to ensure product efficacy, reduce variability, and inform best practices. References in leading dermatologic journals such as J Cosmet Dermatol and J Am Acad Dermatol have emphasized the urgent need for clinical standardization and transparency in regenerative therapies [9,10]. Rigorous identification of exosomes and documentation of potential side effects are essential for safe, scalable integration of exosome therapy into mainstream dermatologic care.

References

  1. Ji S, Zhu Z, Sun X, Fu X. Functional hair follicle regeneration: an updated review. Signal Transduct Target Ther. 2021 Feb 17;6(1):66. doi:10.1038/s41392-020-00441-y. PMID: 33594043; PMCID: PMC7886855.
  2. AlviArmani Research Institute. AlviArmani Advancements. 2024. https://www.alviarmani.com/alviarmani-advancements/
  3. AlviArmani Research Institute. Breakthrough Options in Hair Loss Treatment for Men – 2025. https://www.alviarmani.com/hair-loss-treatment-for-men-breakthrough-options-in-2025/
  4. Cheng M, Ma C, Chen HD, Wu Y, Xu XG. The Roles of Exosomes in Regulating Hair Follicle Growth. Clin Cosmet Investig Dermatol. 2024;17:1603–1612. doi:10.2147/CCID.S465963.
  5. Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plast Surg. 2024;48(21):4262–4271. doi:10.1007/s00266-024-04332-3.
  6. Shimizu Y, Ntege EH, Sunami H, Inoue Y. Regenerative medicine strategies for hair growth and regeneration: A narrative review. Regen Ther. 2022;21:527–539. doi:10.1016/j.reth.2022.10.005.
  7. Hayatdavoudi A. Exosomes in Hair Loss: Literature Review. AlviArmani Research Institute. 2024. https://www.alviarmani.com/exosomes-in-hair-loss-literature-review/

  8. AlviArmani Research Institute. Exosome Treatment for the Crown. 2024. https://www.alviarmani.com/exosome-treatment-for-the-crown/

  9. Gupta AK, Wang T, Rapaport JA. Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions. J Cosmet Dermatol. 2023 Sep;22(9):2424–2433. doi:10.1111/jocd.15767.
  10. Paiewonsky B, Heinen N, Bellefeuille G, et al. Exosome therapy for scalp hair growth—A review of the in vivo and in vitro evidence. J Am Acad Dermatol. 2022;87(3):e123–e130. doi:10.1016/j.jaad.2022.04.055.