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Would You Get a Fat Transfer With Someone Else's Fat?

allure.com

Would You Get a Fat Transfer With Someone Else's Fat?

These days, it’s rare to write about plastic surgery without mentioning fat. We’re either losing it (courtesy of GLP-1s), removing it (via liposuction, the top-ranking surgical procedure last year), reusing it (to plump and contour), or, not uncommonly, doing all three in succession—a sort of carefully orchestrated fat shuffle.

Now, plastic surgeons are experimenting with a first-of-its-kind body filler derived from—guess what—fat. Donated human fat, to be exact, which has been procured from cadavers and meticulously processed into a thick injectable called Alloclae. Donor tissue—which includes everything from skin and cartilage to ligaments and heart valves—is frequently used in all fields of medicine, including aesthetics, but for some patients, the idea of receiving “fat from a dead person is still a little macabre,” says Troy Pittman, MD, a board-certified plastic surgeon with practices in Washington, DC, and New York City.

To secure the donor adipose tissue—aka fat—Tiger Aesthetics, the makers of Alloclae, partners with recovery agencies who “work closely with healthcare providers and family members of donors to review the scope of the deceased individual’s donation,” says a representative for Tiger. Some of you may be morally opposed to (or just totally turned by) the idea of using human parts for cosmetic purposes and will choose to avoid Alloclae just as you might forgo Botox (which contains albumin, a protein in human blood) or exosomes (which are commonly sourced from human cells). But this donated fat can also be considered “a natural alternative [to synthetic fillers and implants],” says Dr. Pittman, explaining that the donor tissues are really acting as a scaffolding for your own fat to grow into. “Once your body incorporates the graft, the fat is going to be more yours than the donor’s.”

This isn’t the first time Allure has reported on Alloclae. Back in January, before the product officially launched, I included it in a story about the fat-stimulating shot Renuva. Alloclae isn’t a Renuva knockoff, however. It falls into a separate category all its own. What makes it unique and “potentially groundbreaking,” says Darren Smith, MD, a board-certified plastic surgeon in New York City, is the inclusion of intact, nonliving donor fat cells (and their naturally occurring growth factors), which impart instant volume. Supporting the fat cells in the formula is a proprietary stew of extracellular matrix proteins. These collagens, elastins, and glycoproteins help the donor cells integrate into the body’s own tissue while encouraging innate fat cells and blood vessels to bloom in the area. Renuva, if you recall, is fat cell-free and composed solely of fat-adjacent proteins, which recruit the body’s own fat cells over time.

Designed specifically for the body (the consistency isn’t smooth and fluid enough for the face), Alloclae essentially provides a fat transfer—natural, long-lasting volume—without the hassle, anesthesia, expense, and downtime associated with liposuction. Lipo has forever been a prerequisite for fat grafting—surgeons have to harvest fat from the belly, love handles, thighs, or other areas of excess before processing it and reinjecting it into the body—but it unequivocally adds to the cost and recovery of the procedure and presents its own set of risks, namely contour irregularities (lumps, dents, ripples, and otherwise uneven results). Plus, the thinnest of patients—who are increasing in number with the popularity of GLP-1s—aren’t suitable candidates for liposuction (and therefore fat transfer), since they don’t have much fat to spare. Alloclae not only offers a workaround for these people, but also allows for a non-surgical—and potentially less expensive—fat grafting experience for everyone who might want one. Board-certified plastic surgeon Ashley Gordon, MD, tells me that in her Austin, Texas practice, patients currently pay between $5,000 and $7,000 for 25 ccs of Alloclae, which is enough to “feather in the cleavage” for a modest boost or to hide the edges of breast implants, which can show through the skin of slender patients. Fat grafting done for the same purpose would cost $10,000 or more, because of the time and anesthesia involved with the lipo.

“Is it FDA approved?” This is generally the first question we’d urge you to ask about any product you might put in your body. But human tissue-derived materials aren’t vetted in the same way as drugs (like botulinum toxins) and devices (fillers and breast implants). As with Renuva, the FDA regulates Alloclae as a human cell, tissue, and cellular and tissue-based product (HCT/P), which means that while it must meet certain requirements—related to minimizing the risk of disease transmission as well as contamination during manufacturing, for instance—it doesn’t technically have to be “approved” or “cleared” by the FDA, per the agency’s web site.

The Center for Biologics Evaluation and Research, a branch of the FDA, governs these materials, ensuring they meet stringent requirements for safety and sterility. Donors must be thoroughly screened and tested to protect against infectious diseases and microorganisms, for example. (Before gifting any tissues, Alloclae donors “go through an aggressive screening process after they’ve passed away,” explains Sachin M. Shridharani, MD, a board-certified plastic surgeon in New York City and clinical trial investigator for Alloclae.) Additionally, donated tissues must be cleaned and processed in accordance with specific protocols to remove possible contaminants and reduce DNA and other cell components that could provoke an immune reaction or all-out rejection of the fat. “We know that you need to have less than a certain amount of DNA per volume in order to be safe,” notes Dr. Smith, “Alloclae is well below that established standard.”

While FDA requirements for tissue-based products are stringent, the FDA doesn’t demand the same caliber of clinical data—meaning long-term studies on large numbers of real people—as it does when evaluating drugs. When Allure reached out to the FDA for comment on the regulation of Alloclae, a representative for the organization stated that, “The limited information provided on ‘Alloclae’ is not sufficient for us to determine how ‘Alloclae’ is appropriately regulated.”

The published data that currently exists on Alloclae is what’s known as basic science literature—studies involving human cells and mouse models—which essentially shows that the composition of the donor tissue resembles that of native human fat and confirms that any potentially triggering DNA materials have been minimized. The studies also demonstrate that the product does, indeed, integrate into surrounding tissue and promote the growth of new fat cells and blood vessels for a limited time after injection.

When performing a lower body lift on a woman who’d previously had Alloclae injected in the same area, Kamakshi R. Zeidler, MD, a board-certified plastic surgeon in Campbell, California, had the rare experience of seeing the product in the body, three months after it was placed. (Dr. Zeidler is a clinical study investigator for Alloclae.) The Alloclae appeared to be “very well accepted [by her tissues] and it was remarkably soft,” she says.

As for studies involving actual patients, the company says they are “presently supporting five clinical study sites in the U.S. that are treating approximately 50 patients” and that “the study is focused on the application of Alloclae in the hips, more specifically when Alloclae is used to improve the appearance of hip dips.” (These are slight indentations that some people have between their hips and thighs.) While the company does not have results to share at this time, they can say that “several hundred patients have received Alloclae so far this year in both the hip and breast areas and we have received a lot of positive feedback.”

Before (left) and after using Alloclae to correct a “hip dip.” Courtesy of Dr. Darren Smith.

Some doctors have reservations about injecting Alloclae into the breasts specifically, given its relatively short track record. Steven Teitelbaum, MD, a board-certified plastic surgeon in Santa Monica, doesn’t currently stock Alloclae, but says he would consider using it to camouflage divots on the body if he ever encountered patients with this problem. When it comes to the breasts, however, “I’m just very cautious,” he says. “Before trying it out on my patients, I’d want to know more about how it does in the breast: How long does it last? What happens when it dissolves? What are the chances of mammographic changes and palpable irregularities? Is there a way to remove it if it doesn’t look right? I don’t think we can definitely answer these basic questions yet.”

While the uncertainty and lack of human clinical trial data is a sticking point for some, a number of plastic surgeons have adopted the product over the past year, injecting it into patients’ breasts, butts, and hip dips to lend modest volume and round out curves in a conservative—I repeat: conservative—fashion. This is not a means to a massive rear end. “It’s intended for really elegant contouring,” says Dr. Shridharani. He’s also used Alloclae to remedy “devastating deformities” caused by aggressive energy-assisted liposuction. “I see this all the time—thin patients with contour irregularities from liposuction gone awry,” he says. Most “weren’t really lipo candidates, but their surgeons… took a shot at it, piecemealing together what they thought would be enough fat to give a good outcome.”

Before (left) and after correction of liposuction contour deformity (from another surgeon) using Alloclae. Courtesy of Dr. Darren Smith.

When discussing risks with Alloclae patients, plastic surgeons tend to follow a similar script to the one they use for other fat-grafting patients, says Dr. Gordon. In addition to expected side effects, like bruising, swelling, and soreness, possible complications include blee

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