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Posts Tagged ‘stem cells in plastic surgery’

Stem Cells and Fat Injections in Plastic Surgery

Tuesday, January 20th, 2015

 

Just recently the Food and Drug Administration (FDA) has approved a private company’s (Antria) Phase 2 clinical trial study for the use of fat-derived stem cells in plastic surgery. These trials are set to begin within the next three months. Antria received approval for Phase 1 clinical trials just under two years ago in March 2013.

Stem Cells and fat Injections Dr Barry Eppley IndianapolisAntria is the first company in the world to obtain FDA approval for human studies for stem cell-assisted facial fat grafting study. Antria’s patent-pending process uses liposuction to extract the fat. Within one hour, stem cells can be prepared from that fat. Antria’s process uses its proprietary Adipolyx solution, a collagenase-based reagent, to isolate stem cells from adult fat cells.

While this FDA approval is significant in and of itself, the even greater relevance is what this indicates for the widespread marketing of so-called stem cell procedures in plastic surgery. The reality is that there are really no true stem cell procedures in plastic surgery despite what is claimed or promoted on the internet and otherwise. Procedures touted as ‘stem cell-enriched’, ‘stem cell injections’ or ‘stem cell procedures’ in plastic surgery are misleading.

While fat does contain numerous stem cells, these are inadvertent passengers in what is otherwise and simply put fat injections. Extracting fat by liposuction and concentrating it for injection for soft tissue augmentation does not make it a bone fide stem cell treatment. This is a marketing tactic, which although very appealing to patients, implies properties of the injection treatment that it does not have.

fat injections to forehead dr barry eppley indianapolisFat injections have many benefits from adding soft tissue volume to improving the vascularity of the injected tissues. But whatever role the percentage of stem cells in the fat has in these benefits is highly speculative. That should not he confused with a highly concentrated and pure source of stem cells which is what is currently being studied in human clinical trials

Dr. Barry Eppley

Indianapolis, Indiana

The Regulated Use of Stem Cells in Plastic Surgery

Saturday, April 6th, 2013

 

Stem cells has understandably caught the imagination of both plastic surgeons and patients alike with their regenerative potential. This has led over the past few years to surgeons promoting their benefits to patients by so-called stem cell-enhanced or derived procedures. From facelifts to fat grafts, the moniker of the words ‘stem cells’ confers an improved method which leads to better or more long-lasting results. Such promotions have been done even though the FDA has not approved any stem cell therapies for cosmetic use.

Manufacturers of devices that can create stem cell concentrates have also emerged. This is usually done by taking fat obtained by liposuction, processing it through an on-site machine, and then a near immediate stem cell preparation obtained for patient re-introduction, usually by injection, is available. Laboratories also began offering services that will also take a patient’s fat, extract the stem cells, and grow them in cell culture to be available for use weeks later. The patient’s stem cells could also be stored and used in the future if desired.

Despite the initial tremendous enthusiasm and unregulated behavior when it comes to stem cell use, that has come to an abrupt end in the past year. The American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgeons issued policy statements that their members should avoid offering and marketing stem cell procedures. This position is based on the scant human evidence in the medical literature to support the benefits of injecting stem cells into patients. While there may be real benefits to the use of stem cells, it is way too early to know what their actual benefits are, how they might work and what are the best indications for their use. Long-term controlled human studies need to be done for various plastic surgery indications to determine their efficacy…just like the approach used for drugs.

While plastic surgeons have been admonished by their own societies to cease stem cell therapies, the manufacturers and laboratories of stem cell-derived devices have received more stern edicts. Recent legal rulings have sided with the FDA that all companies processing stem cells or selling machines that extract and concentrate stem cells must do so through a formal FDA regulatory process involving controlled human clinical trials. There will no fast-tracking or short cutting to human use based on the comparative use of processing blood and blood-derived products. Basically the legal ruling is that fat is not blood and and large studies involving human participants is needed.

Adult stem cells are found in various locations throughout the body, but fat has the highest concentration of them. Obtaining stem cells from liposuction-derived fat has brought their potential use to quick fruition. But with this potential may come unknown risks that are more likely to be revealed (if indeed they do exist) in controlled human clinical trials than theoretical plastic surgery procedures that are highly marketed.

Dr. Barry Eppley

Indianapolis, Indiana

The Unapproved Use of Stem Cells in Cosmetic Surgery

Sunday, December 23rd, 2012

 

Stem cells are the rage in medicine and their potential application for cosmetic changes is no exception. Since fat has become discovered as a resplendid source of stem cells, it has become relatively easy to acquire one’s stem cells from liposuction harvests and grow them in great numbers. As a result, numerous private laboratories have emerged offering stem cell growth and storage. This has led to numerous doctors across the country offering so-called stem cell cosmetic procedures and injections.

The appeal of stem cells therapies to potentially improve aging, wrinkles and sagging tissues is understandably irresistable. But one of the stark realities of stem cells is that no one knows what they will actually do if implanted. While the understanding of the basic biology of stem cells is well known, how they interact with other cells and materials after being implanted is far from an exact science. There are presumed to have remarkable regenerative properties, but there is not one single scientific paper that has ever actually shown that to be true in human application. Quite frankly, stems cell for cosmetic applications in humans is really an experiment even if it is the patient’s own grown cells that being used.

This human experimentation of stem cells in cosmetic surgery is illustrated in a recent report that appeared in Scientific American. A California woman complained of a swollen eyelid, an inability to open it well and hearing a strange sound when she did months after having received a new cosmetic procedure months earlier. The procedure was a ‘stem cell facelift’ where stem cells obtained from her fat by liposuction and then isolated were injected in combination with an injectable filler around her eyes. In subsequent surgery on her eyelids, a different surgeon than the injector removed bone fragments around the eye which were the source of her swelling and eyelid motion restriction. The sounds the woman heard appeared to have been caused by bone fragments rubbing against bone fragments.

While the injectable filler used was not identified in this report it undoubtably was Radiesse, a particulated filler that contains calcium hydroxyapatite particles as part of its composition. The stem cell treatment appears to have been a concoction of Radiesse and stem cells with the theory presumably being that it would improve the longevity of the filler’s effects. What was not predicted was that some of the hydroxyapatite particles served as a nidus for stem cell conversion into bone. In hind sight, this potential reaction seems obvious. But the euphoria of using stem cells and the lack of any previous studies using this combination led to this one patient’s unprecedented iatrogenic affliction.

It is important for patients to understand that the FDA has not approved any cosmetic procedures which use stem cells…or at least so claims. The more common and widely popular use of fat injections undoubably contains stem cells but their incorporation into the injectable treatment is inadvertent and the stem cells are not altered. Extracting stem cells and isolating and manipulating them for re-injection for human cosmetic alteration is now unapproved and requires a controlled FDA-regulated study in which to do it.

Whether stem cells are the fountain of youth for humans, or at least offers some spot areas of physical improvement, will now await years of further study.

Dr. Barry Eppley

Indianapolis, Indiana

Stem Cell Applications in Cosmetic Plastic Surgery

Monday, November 21st, 2011

The field of stem cell research has spurned a lot of new potential medical applications. Enthusiasm is high as to what stem cells may do and many almost give them magical properties and disease curative capabilities. Much of this enthusiasm is at least partially warranted based on a large number of animal and cell culture studies which show some extraordinary results.

The allure of stem cells for plastic surgery applications has not gone unnoticed. Their use in plastic surgery is spurned by several driving factors. The first is their autologous nature and our familiarity of harvesting a fat donor source of stem cells through liposuction. Many problems in plastic surgery particularly of cosmetic concern is the aging of soft tissues, exactly what stem cells can theoretically help reverse. But the pivotal technology that brings stem cell use in plastic surgery a reality is that of commercial stem cell production. There are numerous companies that have emerged that offer to grow stem cells from patients in a timely manner and at a reasonable expense. Since these are cells that are being transplanted back into the patient from which they came, there is no objection yet to their use by the FDA.

Now that stem cells are available, the next question is exactly what in plastic surgery are they good for? Stem cells are different from that of injectable fat grafting in that volume is not being replaced. Fat injections add substantial volume which is why they have made facial volumetric enhancement and breast and buttock augmentation possible. While these fat grafts do have some stem cells in them, they are not really true stem cell injections. The stem cells are inadvertent passengers along with the much greater number of fat cells. The use of such monikers as ‘stem cell injections’ and stem cell-enhanced fat injections’ used by some surgeons are marketing terms and not indicative of scientific reality.

When thinking about how to use stem cells in cosmetic plastic surgery, one potential application is their use as an adjunct or supplement to an existing technique. This would be adding stem cells to enhance the effectiveness of an established treatment method. The obvious choice would be that of adding them to fat injections. While fat injections do naturally have some stem cells, their numbers are low and their viability in question. Adding a concentrate to fat injections would increase their numbers and one would be more certain that they were viable. The question is the ratio of stem cells to the fat injectate and what is a truly effective percent. No one knows but it would seem logical that fact injections into the face would be more appropriate given the lower amount of fat used and the higher ratio of stem cell volume that could be added. Stem cells could also be added to any of the available synthetic injectable fillers used for facial wrinkles, folds and volume enhancement as a theoretical alternative to fat injections. Or they could be added to grown autologous fibroblasts for injection creating the ultimate synthesis of cell culture technologies.

The other application concept is that of pure stem cell injections alone. It would be used by injecting the cell concentrate into the desired tissue target with the intent of creating a rejuvenative effect much like the way we use synthetic injectable fillers today. Whether they could serve as an alternative to injectable fillers creating a delayed volume effect through cell stimulation or conversion to adipocytes or fibroblasts is theoretically possible. Injecting directly into facial wrinkles and folds would be easy to do as stem concentrates would flow through very small needles. Could skin thickness and texture be improved by direct stem cell injections?

 

While stem cells are now available and their biologic appeal is obvious, the cosmetic applications for which they would be most beneficial is not yet known. This is sure to create a flurry of clinical activity in this area from many inventive and entrepreneurial cosmetic practitioners in the near future.

Dr. Barry Eppley

Indianapolis, Indiana


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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