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Karli Health

Exosome Therapies

What Are Exosomes?

Exosomes are tiny, natural delivery packets created by cells in your body (including stem cells). Think of them as microscopic bubbles (much smaller than cells) filled with materials like proteins, amino acids and small pieces of genetic code (microRNAs). These cargoes carry communication signals from one cell to another, helping your body coordinate healing, control inflammation, and manage repair. Because exosomes are not whole live cells, they are felt to have fewer risks, delivering messages to support healing and tissue repair without needing to grow or divide like a stem cell would.

There are two common sources:

  • Autologous exosomes come from your own blood (for example derived from PRP or plasma). Because they originate from you, there’s minimal risk of immune reactions and an excellent safety profile.
  • Perinatal exosomes are taken from birthing tissues like umbilical cord blood or tissue, placenta and amniotic fluid, isolated from healthy births. These are processed in labs to isolate and concentrate the exosomes, ensuring sterility, potency, characterization, and preserving functional cargo. Production companies emphasize strict manufacturing standards (FDA-registered, cGMP compliance, batch-testing, viability, etc.) to ensure product purity and safety.

What Florida Law Allows & What You Should Know

With Florida’s new stem cell law (SB-1768 / HB-1617, effective July 1, 2025), licensed physicians (MD or DO) are permitted to offer certain non-FDA-approved regenerative biologics – including exosomes only under specific conditions. These include:

  • Treatments must be for orthopedic conditions, wound care, or pain management. These are the legally defined permitted uses.
  • Exosome products must meet vendor standards: ethically sourced, processed in accredited, FDA-registered labs, with documented sterility, viability, and chain of custody.
  • Patients must receive comprehensive informed consent: a clear, written explanation that the therapy is not FDA-approved, its potential benefits, risks, alternatives, and what is known vs unknown.

These rules are meant to increase transparency, safety, and to ensure patients can make educated decisions when considering exosome therapies.

What Exosome Therapies Are Used For

Based on current research and emerging clinical evidence, exosome therapies (autologous or perinatal) are being explored for a variety of conditions, including but not limited to:

Area

What Exosomes May Help With

Pain & Orthopedics

Joint pain, cartilage repair, tendon or ligament injuries, reducing inflammation and accelerating healing in musculoskeletal injury.

Wound Care

Chronic non-healing wounds, ulcers, scar revision, improved skin regeneration.

Skin & Aesthetics

Skin texture improvement, anti-aging, minimizing wrinkles, post-procedure healing, reducing inflammation.

Hair Restoration

Supporting hair follicle health, reducing inflammation, possibly stimulating growth via signaling molecules delivered by exosomes.

Sexual Dysfunction / Wellness

Preliminary use for improving circulation, healing tissue damage, and improving function via regenerative signaling.

 

Questions to Ask About Exosome Therapy

Before choosing exosome treatment, make sure you ask:

  • Is the source autologous (your own blood) or perinatal (birth tissue)?
  • Where is it manufactured? Is the lab FDA-registered, and certified under cGMP? Is there documentation of sterility, viability, and testing of exosome content (growth factors, miRNAs)?
  • Is there clear consent, explaining the therapy is not FDA-approved, what outcomes are realistic, and what risks are known?
  • Is the treatment being used for a condition allowed under Florida law (pain, wound care, orthopedics)?

References:

  1. Bei, H., Hung, P., Yeung, H., Wang, S., & Zhao, X. (2021). Bone-a-Petite: Engineering Exosomes towards Bone, Osteochondral, and Cartilage Repair.. Small, e2101741 . https://doi.org/10.1002/smll.202101741.
  2. Wu, J., Kuang, L., Chen, C., Yang, J., Zeng, W., Li, T., Chen, H., Huang, S., Fu, Z., Li, J., Liu, R., Ni, Z., Chen, L., & Yang, L. (2019). miR-100-5p-abundant exosomes derived from infrapatellar fat pad MSCs protect articular cartilage and ameliorate gait abnormalities via inhibition of mTOR in osteoarthritis.. Biomaterials, 206, 87-100 . https://doi.org/10.1016/j.biomaterials.2019.03.022.
  3. Wu, R., Li, H., Sun, C., Liu, J., Chen, D., Yu, H., Huang, Z., Lin, S., Chen, Y., & Zheng, Q. (2022). Exosome-based strategy for degenerative disease in orthopedics: Recent progress and perspectives. Journal of Orthopaedic Translation, 36, 8 – 17. https://doi.org/10.1016/j.jot.2022.05.009.
  4. Yue, Y., Dai, W., Wei, Y., Cao, S., Liao, S., Li, A., Liu, P., Lin, J., & Zeng, H. (2024). Unlocking the potential of exosomes: a breakthrough in the theranosis of degenerative orthopaedic diseases. Frontiers in Bioengineering and Biotechnology, 12. https://doi.org/10.3389/fbioe.2024.1377142.
  5. Vitha, A., Kollefrath, A., Huang, C., & García-Godoy, F. (2019). Characterization and Therapeutic Uses of Exosomes: A New Potential Tool in Orthopedics.. Stem cells and development, 28 2, 141-150 . https://doi.org/10.1089/scd.2018.0205.
  6. Xue, Y., Riva, N., Zhao, L., Shieh, J., Chin, Y., Gatt, A., & Guo, J. (2023). Recent advances of exosomes in soft tissue injuries in sports medicine: A critical review on biological and biomaterial applications.. Journal of controlled release : official journal of the Controlled Release Society. https://doi.org/10.1016/j.jconrel.2023.10.031.
  7. Xiong, M., Zhang, Q., Hu, W., Zhao, C., Lv, W., Yi, Y., Wang, Y., Tang, H., Wu, M., & Wu, Y. (2021). The novel mechanisms and applications of exosomes in dermatology and cutaneous medical aesthetics.. Pharmacological research, 105490 . https://doi.org/10.1016/j.phrs.2021.105490.
  8. Vyas, K., Kaufman, J., Munavalli, G., Robertson, K., Behfar, A., & Wyles, S. (2023). Exosomes: the latest in regenerative aesthetics.. Regenerative medicine. https://doi.org/10.2217/rme-2022-0134.
  9. Krylova, S., & Feng, D. (2023). The Machinery of Exosomes: Biogenesis, Release, and Uptake. International Journal of Molecular Sciences, 24. https://doi.org/10.3390/ijms24021337.
  10. Zhu, Y., Jiang, T., Yao, C., Zhang, J., Sun, C., Chen, S., & Chen, M. (2023). Effects of stem cell–derived exosome therapy on erectile dysfunction: a systematic review and meta-analysis of preclinical studies. Sexual Medicine, 11. https://doi.org/10.1093/sexmed/qfac019.
  11. Xi, O., Han, X., Chen, Z., Fang, J., Huang, X., & Wei, H. (2018). MSC-derived exosomes ameliorate erectile dysfunction by alleviation of corpus cavernosum smooth muscle apoptosis in a rat model of cavernous nerve injury. Stem Cell Research & Therapy, 9. https://doi.org/10.1186/s13287-018-1003-1.
  12. Yang, G., Waheed, S., Wang, C., Shekh, M., Li, Z., & Wu, J. (2023). Exosomes and Their Bioengineering Strategies in the Cutaneous Wound Healing and Related Complications: Current Knowledge and Future Perspectives. International Journal of Biological Sciences, 19, 1430 – 1454. https://doi.org/10.7150/ijbs.80430.
  13. Prasai, A., Jay, J., Jupiter, D., Wolf, S., & Ayadi, A. (2021). Role of Exosomes in Dermal Wound Healing: A Systematic Review.. The Journal of investigative dermatology. https://doi.org/10.1016/j.jid.2021.07.167.
  14. Bian, D., Wu, Y., Song, G., Azizi, R., & Zamani, A. (2022). The application of mesenchymal stromal cells (MSCs) and their derivative exosome in skin wound healing: a comprehensive review. Stem Cell Research & Therapy, 13. https://doi.org/10.1186/s13287-021-02697-9.
  15. Poddar, N., Aratikatla, A., & Gupta, A. (2025). Therapeutic potential of stem cell-derived exosomes in hair regeneration: A systematic review. World Journal of Stem Cells, 17. https://doi.org/10.4252/wjsc.v17.i7.108519.
  16. Ersan, M., Ozer, E., Akin, O., Taşlı, P., & Şahin, F. (2024). Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plastic Surgery, 48, 4262 – 4271. https://doi.org/10.1007/s00266-024-04332-3.
  17. Hamdan, Y., Mazini, L., & Malka, G. (2021). Exosomes and Micro-RNAs in Aging Process. Biomedicines, 9. https://doi.org/10.3390/biomedicines9080968.
  18. Hamdan, Y., Mazini, L., & Malka, G. (2021). Exosomes and Micro-RNAs in Aging Process. Biomedicines, 9. https://doi.org/10.3390/biomedicines9080968.