Are exosome treatments FDA-approved?

No. The FDA states there are currently no approved exosome products for any therapeutic use, and it has warned patients about unapproved stem cell and exosome products for years. If a product is being marketed as an FDA-approved exosome therapy, that claim does not match the regulatory record.

At Aloha Stem Cell, the treatments we discuss are autologous, which means the material comes from your own body: cells from bone marrow or fat tissue, and platelets from your own blood, processed in the clinic for same-day use. There is no donor-derived or manufactured exosome product in the picture, and we are transparent about what we do and do not offer.

Regulatory honesty is part of clinical honesty. When a field is crowded with unapproved products and exaggerated claims, the safest question a patient can ask is simple: what exactly would be injected, where did it come from, and what does the evidence actually show for my condition? Our team answers all three directly.