Examining the Uncertainties Surrounding Exosome Therapy in Androgenetic Alopecia: A Call for Evidence-Based Practice

March 2024 | Volume 23 | Issue 3 | e86 | Copyright © March 2024


Published online February 14, 2024

Michael G. Buontempo BSa, Lina Alhanshali BAb, Mirena Ide MDc, Jerry Shapiro MDd, Kristen Lo Sicco MDd

aHackensack Meridian School of Medicine, Department of Dermatology, Nutley, NJ 
bSUNY Downstate College of Medicine, Brooklyn, NY 
cUniversidade Estadual de Campinas, UNICAMP, SP, Brazil 
dThe Ronald O. Perelman Department of Dermatology, NYU Grossman School of Medicine, New York, NY



and reliability, allowing for a  more accurate assessment of the overall state of the field. Moreover, a uniform reporting method will ensure that patients receive the best possible care by providing healthcare providers with a clear and comprehensive understanding of the benefits and limitations of exosome therapy. This will also help to minimize the risks associated with exosome therapy and promote the development of safe and effective treatments for hair loss.

CONCLUSION

The potential of exosome therapy as a new treatment option for hair loss is promising, however, requires further research and development to fully comprehend its benefits and limitations. One aspect to consider is the current absence of Food and Drugs Administration (FDA)-approved exosome products. In 2019 and reiterated in 2020, the FDA issued a statement warning that exosomes are not approved, nor have they been proven effective, in response to reports of five patients experiencing serious adverse events, including infection and sepsis, within two months of being treated with exosome products.

To advance the field of exosome therapy, it is critical to establish a standardized approach to reporting research and patient outcomes. This will facilitate the development of evidence-based guidelines, support the safe and effective use of exosome therapy, and provide a comprehensive and accurate understanding of the therapy's efficacy. While the current state of exosome therapy research is still in its early stages, future studies must focus on several important factors, including the composition and source of exosomes, the mechanism of action in promoting hair growth, and the long-term effects of exosome therapy. 

It is imperative that we establish proper reporting methods and standardization in classifying exosome treatments. This will enable effective comparison and analysis of future studies, leading to a better understanding of the therapy and its effectiveness, and ultimately ensuring the safe and successful use of exosome therapy for hair loss.

DISCLOSURES

Dr Shapiro is a consultant for Pfizer, Eli Lilly, Eirion, Follica, and Replicel Life Sciences. Drs Shapiro and Lo Sicco have been investigators for Regen Lab and are investigators for Pfizer. Dr Lo Sicco is a consultant for Pfizer and Aquis. MGB, LA, and MI have no conflicts to disclose. 

REFERENCES

 
  1. Park BS, Choi HI, Huh G, et al. Effects of exosome from adipose-derived stem cell on hair loss: A retrospective analysis of 39 patients. J Cosmet Dermatol. 2022;21(5):2282-2284. doi:10.1111/jocd.14846. 
  2. Zhuang J, Chen Y, Hu J. Treatment of Anaphylaxis After Injection of Stem Cell Exosomes With 5-Fluorouracil and Triamcinolone Acetonide. J Craniofac Surg. 2023;34(2):e198-e199. doi:10.1097/SCS.0000000000009034. 
  3. Huh CH. Exosome for hair regeneration: From bench to bedside. Journal of the American Academy of Dermatology. 2019: 81(4). doi:10.1016/j. jaad.2019.06.256. 
  4. Dehghani L. Exosome Effect on Prevention of Hairloss. https://clinicaltrials. gov/ct2/show/NCT05658094. Accessed: 6/19/2023 
  5. Kost Y, Muskat A, Mhaimeed N, et al. Exosome therapy in hair regeneration: A literature review of the evidence, challenges, and future opportunities. Journal of Cosmetic Dermatology. 2022;21(8). doi:10.1111/jocd.15008. 
  6. Taghiabadi E, Nilforoushzadeh MA, Aghdami N. Maintaining hair inductivity in human dermal papilla cells: a review of effective methods. Skin Pharmacology and Physiology. 2020;33(5)doi:10.1159/000510152. 
  7. Exosome Effect on Prevention of Hairloss. ClinicalTrials.gov. 2023. Accessed: 6/19/2023 
  8. Minimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines. Journal of Extracellular Vesicles. 2023. doi:10.1080/20013078.2018.1535750. 
  9. Nelson BC, Maragh S, Ghiran IC, et al. Measurement and standardization challenges for extracellular vesicle therapeutic delivery vectors. Nanomedicine (Lond). 2020;15(22):2149-2170. doi:10.2217/nnm-2020-0206. 
  10. Gangadaran P, Rajendran RL, Kwack MH, et al. Application of Cell-Derived Extracellular Vesicles and Engineered Nanovesicles for Hair Growth: From Mechanisms to Therapeutics. Front Cell Dev Biol. 2022;10:963278. doi:10.3389/fcell.2022.963278. 

AUTHOR CORRESPONDENCE

Kristen Lo Sicco MD kristen.losicco@nyulangone.org