4 Reasons Why You Should Avoid Exosomes For Hair Loss
As promising as exosomes looked for hair regrowth, the FDA has not approved this therapy for hair loss and issued physicians a warning advisory to not promote or advertise the therapies.. In part, there is still a lot to learn about stem-cell therapy and quality control is significantly lacking. For this reason, Davis Hair Restoration has abided with the guidance of the FDA and does NOT offer exosome therapy for hair loss at this time.
Below, we summarize the reasons to avoid exosomes for hair loss therapy.
Exosomes For Hair Loss Is Expensive
Despite a lack of rigorous evidence to prove benefit, exosome therapy is quite expensive due to its novelty and production costs.
The estimates range from anywhere between $3,000 and $10,000 — which is nearly the costs of more effective and permanent treatments like FUE hair transplant.
Exosomes For Hair Loss Requires Maintenance
There is no data on the long term efficacy of exosomes, however it is likely similar to PRP therapy for hair loss requiring maintenance treatment. However, without clear data on efficacy, the cost of such treatment is astronomical and unjustified.
Exosomes For Hair Loss Have Potential Side Effects
Overall, exosomes appear safe, but not entirely risk free! The lack of quality control on available products appears to be the greatest risk.
At this time, more information is needed, however anecdotal reports on adverse events include:
- No exercising for 24-48 hours following the treatment due to risks
- Mild pain and swelling at the site of injection that usually subsides within 24-48 hours
- Heightened sensitivity in the scalp for up to 1 week after treatment
- Risk of infection/bleeding/scarring at the site of injection
- Long-term effects are unknown
Exosomes Are Still An Experimental Treatment For Hair Loss
This is the bottom-line, we just don’t have any data on the safety or efficacy of exosome treatment. Additionally, due to poor quality control, there is significant variability on the market that is being utilized for purported stem-cell therapy. That is a considerable cost to pay for that level of uncertainty.
As a result, the Food and Drug Administration (FDA) has put out two warnings regarding the use of exosome therapy for hair loss and other health conditions.
The first one was released in December 2019 amid concerns of patients experiencing unwanted negative outcomes:
“The Food and Drug Administration (FDA) is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes”
“The clinics currently offering these products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events”
The second warning was a consumer alert issued in July 2020 to warn people who were using exosome therapy to treat problems far more debilitating than hair loss:
“FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk”
“Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood”
Davis Hair Restoration recommends potential patients to avoid the use of exosome therapy for hair loss until further FDA guidance. The early anecdotal experience is promising and merits further study to confirm its efficacy and safety in humans in a clinical trial setting. Clinical trials are also needed to determine the best way to manufacture and apply exosome therapy, and whether different tissue sources of exosomes affect the therapeutic potential. If established, exosome therapy may one day become a leading therapeutic modality in hair restoration.