OPINION REGENERATIVE MEDICINE PRP is a growing autologous and point-of-care treatment everything is done in the doctor s office at the same time. 60 ] October 2012 prime-journal.com
REGENERATIVE MEDICINE OPINION BUSINESS BOOMING IN REGENERATIVE MEDICINE Emmanuelle Bassmann discusses the recent advances in state-of-the-art natural regenerative medicine, from fat grafting and injectables, to topical skincare treatments. REGENERATIVE MEDICINE has been called the next evolution of medical treatments by the US Department of Health and Human Services. With its potential to heal, this new field of science is expected to revolutionise health care. A simple way to define the vast array of techniques falling under the category of regenerative medicine is that they all aim to replace or regenerate human cells, tissues or organs, in order to restore or establish normal function. In figures, the market was estimated at (US) $7.2 billion last year, and is poised for rapid development in the forthcoming years. Orthopaedics dominates the field at 49% or $1.7 billion in revenue shared among 19 companies. Wound healing is the second largest specialty area by sales at 21%, with 15 companies and $738 million in revenue. Stem cell banking is the third most profitable specialty area, with sales at $312 million. According to Dr Gail Naughton, a renowned regenerative medicine specialist in the US, regenerative medicine intersects the aesthetic medicine market in two ways. First, autologous treatments with the use of one s own cells have been entering the market with treatments such as PRP (platelet rich plasma), fat grafting enriched with adipose-derived stem cells, and reinjection of boosted fibroblasts to rejuvenate the face and erase wrinkles. The second emerging trend is to use growth factors produced by healthy young cells from a safe donor bank in topical formulations applied at the doctor s office, or even at home. Platelet rich plasma PRP treatment sometimes referred to as the Vampire Facelift is a growing autologous and point-of-care treatment everything is done in the doctor s office at the same time. PRP has recently been featured all over the press and promoted on well-watched US TV shows such as The Rachael Ray Show and The Doctors. It is a simple, non-surgical, in-office procedure that entails having blood drawn from your arm, then spun in a centrifuge to separate the platelets. The platelets are then injected into your face, in the hope of stimulating new collagen production. The treatment competes directly with dermal fillers and is made to appeal to patients who prefer the idea of using their own blood rather than a neurotoxin or synthetic filler to erase wrinkles and recover their youthful contours. The procedure takes less than 30 minutes and costs an average of $800. Two or three treatments every 4 6 weeks are usually required. Even though the prices are similar to dermal fillers, which rival it in the EMMANUELLE BASSMANN xxxxxxxxx email: eb@in-trend-ltd.com prime-journal.com October 2012 61
REGENERATIVE MEDICINE OPINION in natural alternatives to synthetic fillers, the fat grafting market has grown considerably in recent years. According to the American Society of Plastic Surgery (ASPS) Procedural Statistics, fat grafting procedures in the US have increased by 19% in 2011 from 2010, with more than 68 000 procedures performed annually. Fat grafting isn t new, but more doctors are using advanced techniques for harvesting, processing and delivering fat grafts to achieve better survival and longevity of the grafted fat. One leading According to the American Society of Plastic Surgery (ASPS) Procedural Statistics, fat grafting procedures in the US have increased by 19%, with more than 68 000 procedures performed annually. actor on the market is Cytori with PureGraft. Once the adipose tissue is removed, it only takes 15 minutes for PureGraft to boost the fat by selectively draining the tumescent fluid, free lipids, blood cells, and excessive fluid from the graft. It iss ready for reinjection. One of the main advantages of Viafill and PureGraft is that they are FDA cleared and give physicians an effective, convenient, and cost-effective method to process the adipose tissue intended for immediate re-implantation. marketplace, the results do not show overnight, taking a few months for the full effects to emerge. This can cause problems, as most patients want immediate results. Furthermore, PRP is not an FDA-approved treatment for cosmetics. The treatment came to the market in orthopaedics and sport medicine in 2002 and was FDA-cleared in 2006 for orthopaedics only; it doesn t have an aesthetic indication in the US. However, the treatment is CE-approved. One of the key actors in the PRP market is Selphyl. Aesthetic Factors, which manufactures the Selphyl system, especially in the US, Japan, Middle East and the UK, has around 300 customers in the US alone since its introduction in 2010. Sanjay Batra, the Chief Executive of Aesthetic Factors, says that Selphyl is growing and will do well, especially with younger patients who need a more subtle rejuvenation; it s a great treatment to correct the early signs of ageing. In the skincare industry, the natural market is growing quickly, so it is easy to imagine that lighter, less synthetic and more natural approaches could bring to the cosmetic market newcomers who would never consider having a botulinum toxin injection, but could be seduced by the regenerative medicine approach. Batra says that the impact of regenerative medicine within the cosmetic market can also be seen in another field that is rapidly gaining ground: fat grafting. Fat grafting In July 2012 Batra s company acquired Viafill from the Lipose Corporation a rapidly growing autologous adipose fat transfer treatment. Driven by an interest A challenge to dermal fillers LAVIV (azficel-t) from Fibrocell is the latest launch also completely based on rejuvenat medicine to challenge synthetic dermal fillers to reverse the clock. LAVIV is a treatment made especially for you from your own skin cells. It works by isolating, purifying and multiplying a patient s own collagen-producing fibroblast cells to smooth out wrinkles. It involves taking a sample of skin cells called fibroblasts, which make collagen, from behind the client s ear. The sample is sent to the company s laboratory, where the fibroblasts are multiplied in cell culture; a process that takes 11 22 weeks. The cells are then sent back to the doctor, who injects them into the nasolabial folds. A series of three treatments spaced every 3 4 weeks are recommended. The treatment costs around $2500. According to Fibrocell Science prime-journal.com October 2012 ] 63
OPINION REGENERATIVE MEDICINE Chairman and CEO David Pernock, LAVIV is the first and only personalised cell treatment approved by the FDA for aesthetic use, and one of only two personalised cell treatments approved in the last decade. LAVIV has been FDA-approved for improvement in the appearance of moderate to severe nasolabial lines. Pernock anticipates supplemental indications for LAVIV for the treatment of acne scars, fine lines and wrinkles around the eyes, lips, and décolletage, and the treatment of restrictive burn scars and vocal cord scarring. Since FDA approval in 2011, over 750 board-certified dermatologists and plastic surgeons have participated in the Fibrocell-approved training programme and can now offer LAVIV to their patients. As reported in a press release distributed by Fibrocell Science on 16 July 2012, more than 700 LAVIV biopsies have been 64 October 2012 prime-journal.com scheduled by physicians for their patients since the US launch in October 2011. Furthermore, they anticipate there will be over 1000 physicians trained by the end of this year. As with PRP, the body takes its time to respond to the treatment full results can take up to 6 months but the effects can last a number of years (though Selphyl needs regular top-ups). With LAVIV, there is a little more science behind it and the treatment is FDA-approved for cosmetics. At-home treatments Regenerative treatments are not only being offered at the doctor s office, but treatments for the home are now also coming to market. ReGenica Skincare was started by Dr Gail Naughton, the inventor of the patent behind SkinMedica s key ingredient, TNS Complex, in SkinMedica s still best-selling serum (launched in 2001). The physician-dispensed three-product anti-ageing rejuvenation system (day, night and post-procedure products) was commercialised by Suneva Medical in June 2012. Naturally-secreted growth factors from reliable cell banks have been used in professional-strength skincare for some years; the big difference with ReGenica is that it is being cultured under conditions that mimic those found in embryonic development, producing a multi-potent cell-conditioned media rich in growth factors that are associated with stem cell stimulation and rapid tissue generation. ReGenica Advanced Rejuvenation Day Repair SPF15 and Overnight Repair have been shown to reduce the appearance of fine lines and wrinkles, improve skin tone, and generate smoother skin over a 10-week period. In two published studies, ReGenica Facial Rejuvenation Complex Post Procedure has been found to improve healing and contributes to more A little fat is taken from the stomach and cultivated to produce a blend of cytokines, growth factors and other proteins, which then become the main ingredients for day/night and eye creams. rapid re-epithelialisation as early as 3 days post-procedure. The pricing is $175 for both day and night cream, and $150 for the post-procedure treatment. Dr Naughton s next ambitious move will be to use a very similar technology to develop topicals against skin cancer; she hopes to prevent the spread of skin cancer cells and even kill damaged cancer cells. Harnessing stem cells Personal Cell Sciences from New Jersey put U Autologous on the market in July 2012, a skincare line only sold by plastic surgeons, which uses our own adipose stem cells. A little fat is taken from the stomach and sent to a laboratory. The stem cells are extracted and most are stored for future use. The rest are cultivated to produce a blend of cytokines, growth factors and other proteins, which then become the main ingredients for day/ night and eye creams. The company charges $3000 for the first month, inclusive of all the costs of making the products plastic surgeon s fees for the extraction, the storage and culturing of fat cells, and the creation and delivery of the end-result skincare products directly to the client. Then it costs $1500 per month to keep receiving the day/night and eye creams, which are based on that initial work. Conclusions In the doctor s office, the use of human-derived tissue and autologous tissue from you to you will keep growing to offer a more permanent and natural way to reverse the clock. With regard to at-home treatments, more scientific data are needed to prove that human-derived stem cell topicals are performing better than plant-derived stem cells, which constitute the top ingredient in skincare today. On the question of applying your own cells from a jar every morning, it is too early to tell whether the market will respond positively. One thing that companies will be expected to provide is information about their delivery systems and prove that these state-of-the-art ingredients will actually penetrate the skin, reaching the right destination to be effective.