FDA Approves laViv Cell Therapy For Nasolabial Folds

Wednesday, June 22, 2011 5:33 PM

Based on a sample of the patient's own fibroblast cells which is then multiplied, laViv is an injectable that has been FDA approved to treat the smile lines around the mouth

It seems the first step to proving the worth of cell therapy has just been made. Late last night, the FDA approved the cell therapy treatment laViv, which uses the patient's own skin cells to improve the appearance of moderate to severe nasolabial fold wrinkles. 

 Model Photo

The treatment laViv, created by Fibrocell Science, uses the patients' own cells to create an injectable that can be placed into the nasolabial folds or smile lines. Treatment begins with the extraction of a small amount of fibroblasts, a specific skin cell which in normal skin, is responsible for producing collagen. This fibroblast-rich sample is then multiplied at the company's lab to create laViv, which is then shipped back to the physician to be injected into the wrinkles. The process of creating laViv may take up to 22 weeks from extraction.

The concept of banking tissue is not new, with patients now banking their fat from liposuction with hopes that stem cells are indeed capable of all the wonderful things being promised. These patients are banking on future scientific proof and the fat may be banked indefinitely. However, cell banking for laViv is only for a short period of time while fibroblast cells are being multiplied before they are shipped back to the physician and patient for use.

Similar to the dermal filler Sculptra, an injectable that works by stimulating collagen growth, laViv addresses wrinkles by promoting collagen - one the key components to supple youthful skin. Unlike Sculptra which is synthetic, laViv is created from the patient's own fibroblast cells, which may make it a more natural option, particularly for patients who are allergic or unable to use synthetic facial fillers.

Common side effects, which occurred in two-thirds of the 421 FDA case studies, were mild to moderate redness, swelling, bruising, pain and hemorrhage in the injection site. While it is uncertain how much laViv will cost, a Fibrocell spokeswoman did say it would cost approximately $1,000-$2,000 to create the personalized dermal filler and then between $300-$500 for each of the treatments. The FDA study featured 3 separate treatment sessions per patient to determine the efficacy of laViv. At the time of FDA approval, laViv has proven effective for up to 6 months after the final third treatment.

New Research: Post-Exercise Recovery Advantages of Lowfat Chocolate Milk

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3 new studies reinforce benefits of drinking 'nature's recovery drink' after a tough workout

WASHINGTON (June 2, 2011) – New research suggests an effective recovery drink may already be in your refrigerator: lowfat chocolate milk. Grabbing lowfat chocolate milk after a tough workout helped give both trained and amateur athletes a post-exercise training advantage, according to three new studies presented at the American College of Sports Medicine and published in the Journal of Strength and Conditioning Research this month. Athletes in the studies who had a post-exercise lowfat chocolate milk– with the right mix of carbs and high-quality protein – had improved training times, better body composition (more muscle, less fat) and were in better shape than their peers who drank typical sports beverages with carbohydrates only. 

In three related studies, researchers at the University of Texas at Austin compared the recovery benefits of drinking lowfat chocolate milk after exercise to a carbohydrate beverage with the same calories (similar to a typical sports drink) and calorie-free beverages. The new research linked drinking lowfat chocolate milk after strenuous exercise to:

• Improved Performance: Following an exhausting ride, trained cyclists had significantly more power and rode faster, shaving about six minutes, on average, from their ride time when they recovered with lowfat chocolate milk compared to a carbohydrate sports drink and calorie-free beverage. The 10 cyclists rode for 90 minutes at a moderate intensity followed by 10 minutes of high intensity intervals. During a four-hour recovery period, they drank one of the three recovery beverages immediately and two hours later before heading on a second 40 kilometer ride. (1) 
• Quicker Exercise Adaptation: Compared to the other recovery drinks, chocolate milk drinkers had twice the improvement in V02max – a measure of aerobic fitness and adaptation – after a 4.5 week cycling regimen that included intense exercise five days a week, followed by one of the three recovery beverages. The study included 32 healthy but untrained male and female cyclists.(2)
• Better Body Composition (More Muscle, Less Fat): Chocolate milk drinkers gained more muscle and lost more fat during training, with a 3 pound lean muscle advantage at the end of the 4.5 weeks compared to athletes who grabbed a carbohydrate drink. The 32 healthy but untrained male and female cyclists rode for one hour, five days a week and drank one of the three recovery beverages immediately following and one hour post-exercise. (3)

"Collectively, our research suggests that lowfat chocolate milk – easily accessible for most athletes – can improve performance and aid training for trained and amateur athletes faced with tough routines," said John L. Ivy, Ph.D, lead researcher on the University of Texas at Austin studies. "We may need more research to understand the exact mechanisms, but there's something that chocolate milk naturally has that likely gives it the post-exercise advantage."

Experts agree the two-hour window after exercise is an important, yet often neglected, part of fitness routine. After strenuous exercise, this post-workout recovery period is critical for active people at all fitness levels to help make the most of a workout and stay in top shape for the next workout. 

Chocolate Milk – Nature's Recovery Drink

Lowfat chocolate milk naturally has many of the nutrients most commercial recovery drinks have to add in the lab – including high-quality protein and key electrolytes like calcium, potassium, sodium and magnesium. Plus, it has B vitamins for energy to get you going, and the combo of five bone-building nutrients – calcium, vitamin D, phosphorus, protein and potassium –to help athletes build and maintain strong bones and reduce risk for stress fractures.

Lowfat chocolate milk also contains high-quality protein to help repair and rebuild muscles after strenuous exercise. This new research adds to a growing body of evidence suggesting milk is an effective way to help athletes refuel and recover. 

Sources:

1. Ferguson-Stegall L, McCleave EL, Ding Z, Doerner PG, Wang B, Liao YH, Kammer L, Liu Y, Hwang J, Dessard BM, Ivy JL. Postexercise carbohydrate-protein supplementation improves subsequent exercise performance and intracellular signaling for protein synthesis. Journal of Strength and Conditioning Research. 2011;25:1210-1224.

2. Ferguson-Stegall L, McCleave EL, Ding Z, Doerner PG, Liu Y, Wang B, Dessard B, Kleinart M, Healy M, Lassiter G, Ivy JL. Aerobic exercise training adaptations are increased by post-exercise carbohydrate-protein supplementation [Abstract]. In: American College of Sports Medicine 58th Annual Meeting; 2011 May 31-Jun 4; Denver, CO. Poster nr D-29.

3. McCleave EL, Ferguson-Stegall L, Ding Z, Doerner PG, Liu Y, Kammer L, Wang B, Wang W, Hwang J, Ivy JL. Effects of aerobic training and nutritional supplementation on body composition, immune cells and inflammatory markers [Abstract]. IN: American College of Sports Medicine 58th Annual Meeting; 2011 May 31-Jun 4; Denver, CO. Poster nr C-24.

Fewer Botox Treatments Still Effective

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Portland, Ore. — New research suggests that patients getting Botox (onabotulinumtoxinA, Allergan) treatments can reduce wrinkles with half as many sessions after 20 months, Medical News Today reports.

The research, conducted at Oregon Health & Science University’s Casey Eye Institute, sought to determine whether less frequent Botox treatments could provide longer-lasting reduction of glabellar rhytids. The study included 50 women ages 30 to 50 who received regular Botox injections for two years. 

Medical News Today quotes Roger Dailey, M.D., who led the study, as saying, “We found that after a patient receives Botox Cosmetic injections every four months for two years, the frequency of treatments can be changed to six months with comparable wrinkle-reducing results and high patient satisfaction. Patients who are unwilling to undergo Botox treatments every three months indefinitely because of cost, convenience or other concerns may reconsider if they could achieve similar results with two to three treatments per year.” 

While a treatment schedule of every three months is likely to achieve the best results in the least amount of time, the study concluded that other schedules offer similar results at less cost. 

The study also shows the injections have a prophylactic effect. Dr. Dailey, head of the Casey Aesthetic Facial Surgery Center, says patients who begin getting Botox treatments between their 30s and 50s are able to prevent dynamic wrinkles from forming and eliminate existing wrinkles. “Observations during our subjects’ final visits also suggest that further wrinkle prevention could be achieved with continued treatment beyond two years,” Dr. Dailey tells Medical News Today. 

The results were published in the June 11 issue of Dermatologic Surgery.

Jun 23, 2011
By: Bill Gillette
Cosmetic Surgery Times E-News

FDA Issues New Sunscreen Regs

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Washington — The Food and Drug Administration has released new sunscreen regulations requiring products to pass effectiveness tests and carry labels designed to make choosing the proper sunscreen easier for consumers, the online Wall Street Journal reports. 

The new regulations will, for example, require products that are labeled “broad spectrum” — as are many currently marketed ones — to pass tests for protection against both UVB and UVA rays. The sun protection factor (SPF) numbers currently on sunscreen labels are based on how well and how long the product protects against UVB rays — which primarily cause sunburn — but not against UVA rays. Both types contribute to wrinkles and skin cancer. 

The new regulations further state that sunscreens offering insufficient protection against UVB and UVA rays will be required to carry a warning label noting that the product has not been shown to help prevent skin cancer. Sunscreens that pass the new broad spectrum tests and receive an SPF rating of at least 15 will be allowed to carry labels stating that they reduce the risks of skin cancer and signs of early skin aging if used as directed and in combination with other sun-protection measures. 

Companies with annual sales of less than $25,000 will have two years to comply with the new regulations, while larger companies will have a year.

Jun 23, 2011
By: Bill Gillette
Cosmetic Surgery Times E-News

Avita rolls out ReCell

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Cambridge, England — Regenerative medicine firm Avita Medical, based here, introduced its ReCell Spray-On-Skin at a symposium held at the recent Cosmedica 2011 Congress for Aesthetic & Surgical Medicine held in Bochum, Germany, Medical News Today reports. 

The symposium included presentations demonstrating the use of ReCell from its initial introduction for the treatment of severe burns to diverse indications including scar remodeling and treatment of hypo- and hyperpigmentation conditions such as vitiligo. 

More than 3,500 patients have been treated with ReCell for treatment of burns, hypo- and hyperpigmentation, scar revisions and aesthetic skin rejuvenation procedures, such as wrinkle removal. Use of ReCell has been clinically demonstrated to improve outcomes, reduce morbidity and reduce length of hospital stay and patient-care costs, Medical News Today reports.

Jun 23, 2011
By: Bill Gillette
Cosmetic Surgery Times E-News

FDA Okays First Autologous Filler for Smile Lines

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FDA Okays First Autologous Filler for Smile Lines

June 22, 2011 — The US Food and Drug Administration (FDA) late yesterday approved the first autologous aesthetic cell therapy to improve the appearance of moderate to severe nasolabial fold wrinkles in adults.

The product, azficel-T (laVív), is from Fibrocell Science, Inc, a company focused on developing personalized cell therapies for aesthetic, medical, and scientific applications.

According to the company, creating azficel-T involves a patented technology whereby fibroblasts are extracted from behind the patient's ear and sent to the Fibrocell Science laboratory, where they are multiplied for about 3 months and then frozen until needed.

Azficel-T (laVív). Fibrocell Science Inc

Over a series of 3 treatment sessions, typically 3 to 6 weeks apart, they are injected into nasolabial folds to reduce the appearance of smile lines.

The company says the therapy will become available gradually through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians trained, the number of cities served will expand as well.

The product will be mostly administered by dermatologists and plastic surgeons; only physicians who complete a Fibrocell-approved training program will be able to administer it.

The training program teaches proper biopsy collection and shipment procedures, treatment preparation and injection technique, and logistics tracking to ensure that the cells received by each patient are derived from that same patient.

"Revolutionary" Approach

"The concept of using a patient's own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance," Robert A. Weiss, MD, clinical associate professor, Johns Hopkins School of Medicine, Baltimore, and director of the Maryland Laser Skin and Vein Institute, Hunt Valley, noted in a company-issued statement.

"Since this is a biological process that works over time, [azficel-T] is able to provide gradual and natural-looking results," noted Dr. Weiss, who participated in clinical trials of azficel-T.

A patient's nasolabial fold wrinkles before (left) and after (right) azficel-T treatment. Fibrocell Science Inc:

This approach is "likely appeal to patients who want to take a very new approach to treating wrinkles," Stacy Smith, MD, associate clinical professor in the Division of Dermatology at the University of California–San Diego, who also worked on azficel-T clinical trials, said in a statement.

"By injecting tens of millions of the person's own fibroblasts, patients now have the option to help smooth smile lines by adding cells to replace those that may have been lost through the aging process," he added.

Babak Azizzadeh, MD, FACS, director of the Center for Advanced Facial Plastic Surgery and assistant clinical professor of facial plastic surgery at University of California–Los Angeles, commented, "It's an interesting and novel approach that will generate some excitement among physicians and some patients.

"But at the end of the day," he told Medscape Medical News, "it's going to depend on whether the results are better than with off-the-shelf injectables, such as Juvederm (Allergan), Restylane (HA North American Sales AB), and Sculptra (Sanofi-Aventis), which are the main competition."

Dr. Azizzadeh was not involved in the studies of azficel-T and has not treated any patients with it.

He added that "a limiting factor is that the patients have to have a biopsy and then wait 3 months before they get their injections, and then they have to go through a series of treatments. It's a long process. Physician acceptability, with the length of time involved, may also be an issue."

2 Pivotal Clinical Trials

The FDA approval was based largely on 2 identical phase 3 multicenter, randomized, double-blind, placebo-controlled studies involving 421 patients who underwent 3 treatment sessions approximately 5 weeks apart.

On the basis of investigators' and patients' assessments, a significantly greater proportion of patients demonstrated a positive response to treatment with azficel-T than with placebo, the company notes. The treatment improved the appearance of nasolabial fold wrinkles for the 6 months of patient follow-up after the last treatment. The company said studies are ongoing, looking at how long beyond 6 months after the last treatment the effect may last.

In clinical trials, azficel-T was well tolerated, according to the company. The most common adverse events were mild to moderate injection-site reactions that usually resolved within 1 week. As part of a postmarketing requirement, Fibrocell will set up a registry of approximately 2700 patients to further evaluate the safety of this autologous cell therapy.

By: Megan Brooks

Medscape Medical News © 2011 WebMD, LLC

Send comments and news tips to news@medscape.net.

S.C. Woman Jailed in Implant Case

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Mauldin, S.C. — A South Carolina woman was arrested and jailed in connection with a buttocks implant procedure allegedly performed without a license at her boutique here, msnbc.com reports. 

The New Jersey woman on whom the procedure was performed nearly died afterward, but has since recovered, according to the report. She had come to 35-year-old Michelle Roca’s boutique specifically to get buttocks implants. Investigators allege that Ms. Roca flies in doctors from outside the country to perform procedures at her boutique. Ms. Roca’s family denies the allegations. 

Msnbc.com quotes local police as saying that Ms. Roca did not perform the procedures, but was a facilitator. She allegedly contacted a doctor, arranged the procedures and ensured that the doctor arrived in the country and then left the country afterward.

By: Bill Gillette
Cosmetic Surgery Times E-News

PRESS RELEASE

Press Release:

Dr. Edward Zimmerman, local cosmetic surgeon, was one of 5 physicians who served on an Expert Panel, presentation to spa industry executives on "High-Tech Body Sculpting" at the International Esthetics, Cosmetics & Spa Conference in Las Vegas, June 18-20. Other physicians on the panel were Dr. Mark Berman, immediate past president of the American Academy of Cosmetic Surgery; Dr. Greg Keller who spoke about external body sculpting devices; Dr. Todd Malan, who spoke on Stem Cell augmented fat grafting and Dr. Andre Berger, Medical Director of the RejuvaLife Spa in Beverly Hills.

Dr. Zimmerman did a multi-media presentation comparing and contrasting "LipoSculpting Technologies" currently available in the USA .

Lipofilling Safe in Reconstruction

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Milan — A new study suggests that lipofilling is a safe technique for breast reconstruction following cancer surgery, Medical News Today reports. 

Researchers at Milan’s European Institute of Oncology (IEO) analyzed data on 321 women who had had surgery for primary breast cancer there between 1997 and 2008, and who had received lipofilling as part of their breast reconstruction. These women were matched with 642 women who also had had surgery for primary breast cancer but did not undergo lipofilling. 

After follow-up for an average of 56 months after the primary surgery and 26 months after the lipofilling, investigators found that eight women in the lipofillling group and 19 women in the control group had a local recurrence of their cancer — a statistically insignificant difference. 

In women with noninvasive cancer, there were three cases of recurrence in the lipofilling group and none in the control group. While this was statistically significant, the authors wrote, it may have been affected by the very small numbers involved, the short follow-up and the fact that there were no recurrences in the control group despite previous research suggesting there should be an average recurrence rate of more than 2 percent over this period of time. 

Medical News Today quotes author Jean Yves Petit, M.D., chairman of breast reconstructive surgery at IEO, as saying, “To date, only a few studies have focused on cancer recurrences after lipofilling, and this is the first case-control study to investigate the question and the first publication to show the safety of the procedure. Our overall results do not find any difference in recurrences between the women in the lipofilling and control groups.” 

However, he noted, it is still too early in the follow-up to be able to draw definitive conclusions.

“We urge other teams working in the same field to gather their own results concerning local recurrences after lipofilling in breast conservation treatment,” he says. 

The study was published in Annals of Oncology.

Jun 2, 2011
By: Bill Gillette
Cosmetic Surgery Times E-News