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Regenerative aesthetics: Expanding possibilities and creating controversy

Article-Regenerative aesthetics: Expanding possibilities and creating controversy

Regenerative aesthetics: Expanding possibilities and creating controversy

Few developments are as exciting and full of promise as the future of regenerative medicine. The ability to harness the body’s own natural processes to improve healing and restore injured or otherwise compromised functionality of body tissues seems like science fiction to many, but paradigms are shifting, and the practice of aesthetic medicine is being upended in the process.

The medical aesthetic industry has been uniquely positioned at the leading edge of the movement, according to Kate Goldie, MD, medical director at European Medical Aesthetics Ltd., in London, U.K., a training facility for aesthetic practitioners. “Historically, we’ve been performing treatments that show visible improvements to skin and as it turns out, what makes us look better is often a sign of improved tissue health. We’ve sort of reverse-engineered these to learn their mechanism of action and better address the signs of aging,” she explained.

“In a sense, what we do is regenerative by nature, so our interest in and adoption of regenerative medical therapies is an extension of this, especially in optimization of the microenvironment and generation of soft tissue at the cellular level,” Dr. Goldie continued. “Aesthetic medicine has, as a result, been a part of many of the light-bulb moments revealing how we can safely and effectively use these new tools. Through aesthetic medicine we see people who look better at 50 than they did at 40, and their skin is not only younger looking, but healthier.”

One benefit of these technologies is the more global aspect of improvement at the cellular level. “When we are applying regenerative treatments we are not stimulating just one type of collagen, for example, but many aspects and processes restoring the structure and function of tissue and the mechanisms that support them, the depth of which we don’t fully understand despite the breadth of research so far,” said Dr. Goldie.

Emily S. Rubenstein, DO, of the Swedish Skin Institute in Chicago, Ill., agreed. “In aesthetic medicine and dermatology, we have been treating the skin, in which you can see a visible difference with improvement. So, we know something works by how it looks, which is an honest reflection of its improved health. This, understandably, drives medical interest in these types of products.”

However, the role of aesthetic medicine has been a double-edged sword. Arguably, no other medical field has seen the kind of forward movement impact of regenerative medicine as the aesthetic industry. This is due to modalities such as platelet-rich plasma (PRP) and stem cell therapies, which have been touted as easily and inexpensively improving and speeding recovery, healing and the final result.

Conversely, some see this as snake oil; part of a money grab not sufficiently tested or proven through rigorous science. Given the financial stakes involved, this issue is a challenge that has regularly faced new developments in aesthetic medicine – the balance between hype and scientific substance in an effort to secure market share in a competitive and fertile field.

And this field is indeed fertile. Not only are the developments rife with potential, society as a whole is becoming more in tune with the concepts of wellness and holistic approaches to care. This is partially driven by the trend toward less invasive, less risky and more lifestyle-friendly therapeutic options, but there is more.

“There is a lot more public interest in wellness and this drives the market, everything from plant-based ‘meats’ to IV infusions of vitamins to regenerative aesthetics,” said Farhan Taghizadeh, MD, medical director of Arizona Facial Plastics (Scottsdale, Ariz.). “Consumers see wellness as a pathway to a longer and more productive life. This patient base is interested and more educated, so when they pursue aesthetic treatment, they seek parallel therapies including nutrition or IV therapies, lifestyle coaching and things like hormone balancing.”

People like the idea of using natural or autologous regenerative therapies and may be turned off by some of the established modalities and potential risks involved. “People are wanting to get away from things they perceive as toxins or foreign bodies, which may cause problems, some of which are only recently emerging,” said plastic surgeon Diane Duncan, MD, who practices in Fort Collins, Colo.

Regenerative medicine fits perfectly into the osteopathic philosophy of care, according to Dr. Rubenstein. “These products and their implications are especially intriguing to me,” she said. “The fact that different parts of the body affect and reflect the health of other parts, along with overall health, is part of how we look at the body, healing and wellness. Many physicians are using PRP and newer products, and I’m looking at how I can best incorporate these products into my practice.”

“What were once peripheral ideas in the wound care industry, such as fibroblast-derived exosomes, have become mainstream in the aesthetic industry over the last year,” Dr. Taghizadeh pointed out. “Exosomes derived from tissue cultures represent a huge area with growth potential, if properly managed, because there are a host of regulatory issues surrounding these and other aspects of regenerative medicine.”

As a result, many popular therapies in aesthetic medicine have added regenerative elements. “This makes these technologies accessible to thousands of people each day getting something such as a HydraFacial, microneedling or lasers,” Dr. Taghizadeh continued. “Major companies are integrating these into their repertoire of treatments in some way with proprietary adjunctive components, including modifying their devices to incorpo- rate the dispensation of regenerative medical products.”

Fat is a primary source of regenerative material such as stem cells, “because it is accessible, it comes from our own bodies and we all have plenty of it throughout our lifetimes,” Dr. Taghizadeh indicated. “Micronization of fat, where we process the fat further, exposes more of the regenerative constituents such as stem cells and growth factors, and exposes the tissue to more of the core regenerative components.”

As Dr. Duncan explained, “Macrofat is unprocessed fat, with particles larger than 2.4 mm. Millifat is smaller than that, and microfat smaller still. Nanofat is even smaller and is different than stromal vascular fraction (SVF), which requires collagenase and has been banned by the FDA because by adding the collagenase, even to autologous tissue, it becomes a ‘drug’ and falls under FDA regulation.

“Nanofat is mechanically processed so it does not fall under that designation,” Dr. Duncan continued. “Using the pro- cess proposed by Patrick Tonnard, MD (Belgium), this leaves no adipose, only stem cells. As studied and performed by companies using FDA approved methods, the stem cell counts are significant and can be used.”

Dr. Duncan uses macrofat for significant volume restoration in places like the jawline and cheek, and millifat in areas such as the lips or around the eye where you don’t want any lumpiness or chunkiness. “I don’t use microfat, but it can be injected and some people do that,” she shared. “Nanofat can be injected intradermally to improve skin quality and thickness. There isn’t much else that will do that, I see it as a game changer.”

Regenerative medicine was a hot topic at the Miami Cosmetic Surgery and Aesthetic Dermatology 2020 symposium (MCS). Dr. Rubenstein, who practices with plastic surgeon and MCS chairman, Steven Dayan, MD (Chicago, Ill.), said, “Regenerative medicine was highly discussed at MCS because not only is this technology exciting, but it was sort of the wild west as far as how these therapies were being used, and the FDA has stepped in to tighten regulations and prevent some of the cavalier use of products like exosomes,” she said, referring to the December 2019 public safety notification on exosome products by the FDA.

Exosomes are naturally-produced extracellular vesicles that are a key component of intercellular communication and management of the cellular microenvironment. They are gaining traction as a therapeutic vector, and for good reason, said Dr. Duncan who was among those discussing regenerative medicine at MCS.

“Exosomes, which are a form of secretome, had long been thought of as the trash can of the cell, but they play a major role in the form of local cell-to- cell communication called paracrine signaling,” Dr. Duncan expressed. “We have a growing body of science regarding exosomes. About 91% of the influence of stem cells occurs through exosome paracrine signaling, so you don’t necessarily need the stem cells themselves. They are derived through co-culture with whatever type of tissue you are looking to influence and have remarkable properties.”

“These can be used topically,” Dr. Duncan clarified, “but they cannot be injected. The strong statement made by the FDA in December 2019 makes this very clear. But there are several companies in the process of obtaining FDA I.N.D. (investigational new drug) designations to propel the proper research and development of exosomes.”

Among the available skincare solutions proven to harness the body’s regenerative power, probably the most talked about topical product right now is SoMETM Skincare from Aesthetics Biomedical, Inc. (Phoenix, Ariz.). This emerging PRP-based at- home skincare product is supported by rigorous science demonstrating its efficacy and mechanism of action. PRP is generated from the patient’s blood, then further concentrated and added to a proprietary formulation that stabilizes the PRP and provides a vehicle for easy application. Once created, the product lasts for 90 days.

On a different front, FDA-cleared Renuva adipose allograft matrix from MTF Biologics (Edison, N.J.) serves as a natural volumizer that can be used all over the body. Treatment consists of injecting the bio-compatible matrix and collection of growth factors, collagens and proteins into subcutaneous fat; these provide a framework which keeps the constituents in place and induces the body to replace it with fat cells and necessary support mechanisms naturally, a process which takes place over several months for a natural-looking outcome.

Joel Schlessinger, MD, director of Skin Specialists P.C., in Omaha, Neb., uses PRP, but is very careful about what he does and how he’s moving forward, due to growing controversy in the field. “I’ve been using PRP and I’m very interested in how stem cell and growth factor treatments are developing, there is definitely some potential there. But I’m wary of the way regenerative aesthetics is being put out there so fast, surrounded by hype, with doctors touting their own unique stem-cell or growth factor treatments and branding themselves when the science is still in its infancy in many ways,” he said.

“With any medical advancement, it is incredibly important to responsibly and appropriately develop information and represent products in an evidence-based manner,” Dr. Schlessinger expounded.

“In this situation, unfortunately, we have generally seen hype over substance on a regular and rampant basis. Sadly, the narrative has been developed by doctors who have completely, and sometimes falsely, promoted these regimens to the detriment of science, and sometimes patients.”

This, Dr. Schlessinger explained, has caused an altogether appropriate backlash and growing distrust of these technologies, as well as action from regulatory agencies. “The most unfortunate aspect of this is that some of these technologies have a lot of potential to be extremely beneficial. But, with the cacophony and false information surrounding these, and the hucksters promoting them, it is difficult for legitimate physicians to bring up the idea of these technologies to patients in a credible fashion.

“Make no mistake, this isn’t simply about overexcitement, but avarice,” Dr. Schlessinger continued. “There are a wealth of situations where people have gone off the deep end to trademark terms and inappropriately promote new technologies because of their financial interests, and hold back the science for their own short-term benefit. This impedes the advancement of the science, which is essential for the proper, successful development of truly useful treatments. We now have a situation where a potentially legitimate opportunity for dermatology and plastic surgery has been co-opted, and it is going to be incredibly difficult to bring this back around. It will require significant effort on the part of legitimate researchers in this area.”

PRP for hair loss is a great example, according to Dr. Schlessinger. “I was on the fence about this kind of procedure for about five years, until recently, mainly because of self-promoting physicians and non- physicians who were circling the information. I’ve since come around because I’ve seen a genuine benefit, but sadly, if you search anything with certain terms like ‘PRP’ and ‘stem cell’ in the title, Google will not allow the website to appear in the search because these terms have become so muddied. This makes it harder to promote yourself legitimately, and harder for patients to find proven treatments. It all stems from unethical behavior and claims that are not yet substantiated by the science. This turns a potential profound medical advancement into a hand grenade.”

Despite the controversy, Dr. Schlessinger remains hopeful. “My sincere wish is that these technologies will continue to be researched by legitimate medical professionals and the untruthfulness that has been associated with them can be further exposed, and then overcome, to some degree.”

“It is imperative that we continue to explore these technologies,” Dr. Goldie concluded. “They have the ability to completely change the way we do dermatologic and surgical procedures, improving healing and outcomes in very profound ways.”

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