Without experimentation, there would be no progress, and that’s especially the case when it comes to science. The FDA first allowed the study of botulinum toxin’s effect on health conditions more than 50 years ago. Decades later, it was studied, then approved, as a treatment for wrinkles; today, Botox is possibly the most popular aesthetic procedure worldwide. It takes significant time to understand what innovative treatments are capable of and even longer to get them regulated and approved as an actual therapy. So when the FDA issued a warning letter against exosome treatment—one of today’s buzziest procedures—many aesthetic providers took it with a grain of salt. Here, with the help of exosome experts, we’re breaking down exactly why this treatment is being referred to as “the wave of the future.”
What are exosomes?
To get an understanding of exosomes, let’s break down platelet-rich plasma (PRP) therapy, which some providers are swapping out in favor of exosome treatment. PRP is performed by drawing a patient’s blood, then placing it in a centrifuge to separate the red and white blood cells from the nutrient-packed plasma. In addition to featuring things like proteins and sugars, plasma contains platelet cells, which are rich in growth factors and help heal wounds.
However, they’re not necessarily as potent as exosomes. “Exosomes are vesicles that cells use for communication,” explains Dr. Marina Peredo, a board-certified dermatologist in New York City. “They’re not cells but tiny little bags with all the ‘goodies.’” Platelet cells are actually a common source for the exosomes used in aesthetics treatments, as are placenta and stem cells, but all cells have exosomes—they’re essential messengers that tell cells what to do. “Until about 15 years ago, people thought that exosomes were kind of like the sewer system of the cell, a way to get rid of waste material,” explains scientist Dr. Sanjay Batra, founder of WeThrivv and a former adjunct professor at the Wake Forest Institute for Regenerative Medicine. “No one had any idea that these exosomes are chockfull of pixie dust and magical materials, including growth factors, mRNA, RNA, and things that could influence cell-to-cell communication.”
How do exosomes work in cosmetic treatments?
You may find providers using exosomes as a replacement for—or in conjunction with—PRP. “They have more regenerative potential than PRP, which contains 8 to 10 growth factors. Exosomes contain over 100 different growth factors,” says Dr. Jessie Cheung, a board-certified dermatologist in Chicago who specializes in regenerative medicine. Because they aren’t tied to any specific type of cell, they will send signals to cells in the treatment area to kick things into high gear. “They will wake up cells, keratinocytes and melanocytes and promote new collagen production,” to name a few, explains Dr. Peredo.
Though exosomes are very small, they cannot penetrate and will not be effective when administered to intact skin. They must be applied to skin that has been injured in some way. Dr. Peredo often uses it after Clear + Brilliant or RF microneedling. “[After treatment], the skin is normally red and burning,” she says. She then applies the exosomes, which must be refrigerated (more on this shortly); this instantly cools the skin down and causes redness to subside, expediting the healing process.
Brittany Blancato, a medical aesthetician working for New York City-based board-certified facial plastic surgeon Dr. Yael Halaas, has performed exosome treatments on many clients’ skin, including a scar on someone’s chin. “I did microneedling twice, with exosomes topically afterward, and the results were amazing,” she says. “The discoloration is pretty much gone.” Dr. Jennifer Levine, a board-certified facial plastic surgeon in New York City, recounts one patient who had a travel-related injury that wouldn’t heal after six weeks. “I gave her the exosomes, and when I saw her again four days later, it was almost healed,” she says. “They really work.”
It’s the combination of three different factors that seems to be behind the efficacy of exosomes. Though more research is needed, a study from 2021 shows that they stimulate collagen synthesis, reduce inflammation, and promote angiogenesis, the formation of new blood vessels. These characteristics make exosomes an exciting option for treating not just skin health but hair loss too. “I see more hair growth with a single session of exosome therapy than with PRP,” says Dr. Cheung. Similarly, Dr. Halaas’s patients have impressive results, with one showing significant regrowth three months after just one injectable treatment with exosomes.
It’s worth noting that exosomes are also being used intravenously for pain management. Considering that the FDA has not approved any use of exosomes, let alone this therapeutic or drug-like use, this is especially controversial.
What are the differences between all the exosome products available?
There are a lot of exosome brands on the market, including Kimeravive, Benev, Exocel Bio, and Rion. Hydrafacial even also recently announced that the company plans on releasing an exosome booster sometime this year. The primary differences between these manufacturers’ exosomes are the concentration (or number) of exosomes in the end product and the source of the exosomes themselves.
When used intravenously, there can be several hundred billion exosomes in a single milliliter of product. Injected forms of the treatment use fewer, and topically applied formulas require even fewer to be effective. This is a good thing, as the higher the concentration, the more expensive the treatment. “For topical use, the concentration would be anywhere from 5–25 billion exosomes per mL,” says Dr. Peredo. “If you’re just treating the face, you use one to two mLs; if you do face, neck, and chest, then you probably use five.”
Perhaps obviously, all exosomes are derived from human sources. One common source is mesenchymal stem cells, cells that are capable of self-renewal. “Mesenchymal stem cells are [often] derived from the umbilical cords or amniotic fluid from healthy donor pregnancies,” says Dr. Cheung. They’re also taken from placenta. “Normally, the placenta is discarded,” points out Dr. Peredo. “When you take PRP from someone in their 60s and 70s, the growth factors and platelets are old. When you use exosomes, you inject something that’s very young, like placental cells from a 20-year-old.” However, Dr. Batra notes that the benefits of PRP aren’t often related to age. “Younger patients with younger platelets didn’t always have the best result,” he says. “Remember, a platelet only lives for about seven days, so your body is constantly making new platelets.”
Platelets are another common source of exosomes; platelet-derived exosomes are used by Rion, which in addition to distributing exosomes for clinical use also offers an at-home skin-care collection, ( plated ) Skin Science. These products are formulated with what the brand refers to as platelet extract. This differs from true exosomes—that’s because exosomes are from live cells. “Exosomes are very difficult to keep viable at room temperature, so the products we have either require storage in a special deep freezer and need to be defrosted before use or need to be kept refrigerated and then reconstituted before use,” explains Dr. Cheung.
Anything with true exosomes will not be very shelf stable and will have a short lifespan. Dr. Levine actually whips up exosome-infused Aquaphor for her patients, especially those who have received ablative laser treatment. “We’ve given it to people to heal after procedures, and it works really, really well,” she says. “We tell them to keep it in the refrigerator, keeping it for no more than two weeks.”
Dr. Batra explains that ( plated ) Skin Science formulas are platelet-derived exosomal products for topical use. “It’s what the exosomes release, the payload of what is in the exosomes—proteins and growth factors,” he says. “These proteins are dead. I hate to say it that way, but they still may have a biological effect or improve the appearance of fine lines and wrinkles.” (If you’re familiar with SkinMedica TNS Advanced+ Serum, which use growth factors, it’s a similar concept.)
Are exosomes safe?
The short answer is yes, with the longer answer being that the scientific community isn’t so sure yet, due to limited information. “The real workhorse in regenerative medicine is exosomes,” says Dr. Batra. “They can affect intercellular communication in a really special way. I think it’s very promising. There’s tremendous excitement in the hair world and dermatology.”
It’s worth considering some of the common potential fears of being treated with exosomes. One such concern is that your body could reject them. That’s why, when you get PRP, it has to be sourced from your own body—if a foreign cell is incompatible with your body, your immune system will attack it. Remember though: exosomes are not cells, which is why these little messengers can be extracted from various sources and used by anyone to treat a broad range of concerns.
Another concern is the health or safety of the sourced material—what if the exosomes are pulled from someone with a serious medical condition? That shouldn’t be a worry either. “The manufacturing process essentially purifies the product,” says Dr. Batra. “I don’t worry about taking someone’s blood product—it’s sort of like vodka. When you start distilling vodka, it ends up being very pure. Ketel One tastes like Ketel One every time—because the manufacturing process makes it so consistent.” That does mean, however, that it is important to be treated with exosomes from a trustworthy manufacturer. Just like you wouldn’t get black market butt injections, you need to get reliable exosomes. “You want products with detectable RNA and clinical studies, and you need to consider the tissue source,” says Dr. Cheung.
The real question with exosome safety has to do with your own health. “Exosomes are ways that the cells communicate with each other—if information is telling them to make the body do good things, that’s great,” says Dr. Levine. “But what if there’s a bad cell in your body? In someone who might be predisposed to having a disease, can this magnify it? That’s the flip side of the coin.” While there’s no data to show that exosomes do this, the FDA is saying that the knowledge just isn’t there yet—hence the aforementioned warning letter.
But plenty of experimental and well-regarded aesthetic treatments are not cleared by the FDA—including PRP. “The FDA doesn’t govern the practice of medicine, so a physician can give treatments that are considered off label,” says Dr. Batra. Currently, the FDA has approved the use of PRP only in wound care; using it for facials or hair growth is off label. It takes hundreds of millions of dollars, in-depth studies, and often, decades to achieve FDA approval. In the meantime though, providers are going to continue to treat their patients with cutting-edge exosomes—whether you’re excited to join the experiment is up to you.
