Hundreds of U.S. Clinics Offering Illegitimate Stem Cell “Therapies”

A new study reveals hundreds of clinics throughout the United States are promoting unsanctioned stem cell treatments for conditions such as aging skin and spinal cord injuries.

In an online search, researchers were able to pinpoint approximately 570 clinics providing unauthorized stem cell “therapies.” They tend to be concentrated in a handful of states — including Arizona, California, Colorado, Florida, New York and Texas — but are scattered across many other states as well.

“The clinics usually market stem cell procedures for orthopedic conditions, such as Arthritis and injured ligaments and tendons. This does exhibit medical applications, but is still considered experimental,” medical experts said.

In other instances, with little or no substantial proof, clinics hawked Stem Cell “Facelifts” and therapies for serious conditions such as Chronic Lung Disease, Parkinson’s Disease and Multiple Sclerosis.

If these pricey stem cell treatments are unproven and unapproved by federal regulators, how can these clinics exist?

“I ask myself that question all the time,” said Leigh Turner, a Bioethicist who worked on the study.

Turner, an associate professor at the University of Minnesota’s Center for Bioethics, said attention used to focus on “Stem Cell Tourism” — where people travel to countries such as China, India and Mexico to get unproven treatments.

“I think there’s a misperception that everything here [in the U.S.] is regulated,” Turner remarked. “But these clinics are operating here, and on a relatively large scale.”

Stem cells are basic cells with the potential to mature into various types of body tissue. Medical researchers have been studying the possibility of using stem cells to repair damaged tissue in a range of chronic ills — with minimal success to date.

But the general public has heard about the ‘promise’ of stem cells for years, and it can be easy to be taken in by clinics’ marketing tactics,” Turner stated.

Websites can, for instance, link to published medical studies that make their therapies appear genuine, Turner said. “These businesses can be quite savvy,” he said. “I think it’s asking too much to just tell consumers to be wary. We need to be asking, why should these clinics be allowed to do this?”

Arthur Caplan, a Bioethicist who did not participate in the study, mentioned some explanations for the growth of stem cell clinics.

“The businesses are usually not engaging in interstate commerce, which helps them ‘fly under the radar’,” noted Caplan, who directs the division of medical ethics at NYU Langone Medical Center in New York City.

“Plus,” he said, “there’s a regulatory gray area when it comes to so-called ‘autologous’ stem cell therapy, which refers to treatments that use a person’s own stem cells.”

“If you have cells from your own body reinjected, it isn’t clear that you’re getting a ‘new biologic’,” Caplan explained.

Out of the businesses Turner’s team found, most marketed autologous therapies, usually using stem cells from people’s body fat or bone marrow. But about one-fifth of the businesses claimed to use stem cells from umbilical cord blood or amniotic or placental tissue.

“The issue goes beyond people wasting their money or having their ‘hopes dashed’,” Turner said. “It’s known some have been seriously harmed.”

He mentioned two elderly patients in Florida who died following an unapproved stem cell procedure.

The U.S. Food and Drug Administration has taken steps against specific businesses. Last year, it sent a warning letter to a network of clinics that operate in California, Florida and New York. According to the FDA, the clinics illegally use stem cells from people’s fat tissue to treat conditions such as Parkinson’s, MS, Amyotrophic Lateral Sclerosis (ALS) and Autism.

“Many of these claims are outrageous,” Caplan said. “These clinics are preying on vulnerable people.”

His advice to consumers: “Be wary of any procedure that comes with celebrity endorsements or patient testimonials.”

The FDA has published draft guidelines for stem cell use. A public hearing is scheduled for later this year.

Second Skin

If somebody says they can remove all your wrinkles in seconds and give you young and radiant skin just with the help of an invisible film, which will be painted to the skin, would you do it?  It might sound like a miracle or a dream come true, but Scientists at both M.I.T and Harvard really discovered a treatment that can make that a reality.

Second Skin Anti-aging treatment

In the journal Nature Materials, the researchers revealed the details about the composition of “Second Skin”, which contains commonly used chemicals. These chemicals are safe and meet the guidelines of the Food & Drug Administration. No allergies or irritation were reported after treatment with the “Second Skin”.

The transparent film can be soaked in sunscreen and consequently is used to protect the skin from the sun. It’s also shown to help treat diseases like Eczema, Psoriasis, dark circles, and more, as it soothes and moistens the skin. It’s known to address skin laxity that develops with aging.

The chemicals used in the film are siloxanes; one atom of oxygen combined with two atoms of silicon, which together form polymers and making a chain of repeating units. This treatment has two steps; during the first step, the polymers create a transparent liquid, which is applied on the skin. Then in the second step, the product film is applied, which will link the transparent liquid with the film. Depending on the skin, some sections may require more than others. For instance, skin texture is different under the eyes than it is on the cheeks.

This research was performed by the team at Living Proof, a privately owned small biotechnology company in Cambridge, Ma. They have converted this brilliant science into a beauty product developed by Olivo Laboratories, another privately owned small company in Cambridge. 170 volunteers participated the study with with great results and the most dramatic being the restoration of skin elasticity.

On Monday, May, 9th  2016, this report was given by the Research team and it is the first test of this product. They are working to get more data to submit to the Food and Drug Administration, so that they will receive approval to market it in the coming months.

The Professor in Biomedical Engineering at Columbia, who is not in the research team told Professor Gordana Vunjak-Novakovic, “I think it is brilliant; what they have done is design a clever biomaterial that recapitulates the properties of young and healthy skin. They can use it as sort of a Band-Aid over old and aging skin and get very significant results.”

What are your thoughts on the second miracle skin? Would you do it?

Young Women Developing Melanoma: Is Indoor Tanning to Blame?

A large retrospective case-control study revealed that women with a Melanoma diagnosis prior to age 30 presented with an almost 100% history of indoor suntanning facility use.

Amongst the 63 youngest women who presented with Melanoma diagnoses, 61 had a history of indoor tanning. Younger women reported earlier and more frequent use of indoor tanning facilities as compared with patients whose Melanoma diagnoses occurred later in life. A history of indoor tanning increased the likelihood of a Melanoma diagnosis by two to six times among women 30 to 49. Men were about 50% less likely than women to participate in indoor tanning, and data related to the association with Melanoma risk proved inconclusive.

The findings added to evidence linking indoor tanning to recent increases in Melanoma frequency among young women. The study also offered support for legislative and regulatory efforts to restrict access to and use of indoor tanning facilities, wrote DeAnn Lazovich, PhD, of the University of Minnesota in Minneapolis, and colleagues in JAMA Dermatology.

“Our results indicate that these efforts need to be accelerated and expanded beyond bans on minor access to indoor tanning to curb the Melanoma epidemic, which seems likely to continue unabated, especially among young women, unless exposure to indoor tanning is further restricted and reduced,” the authors stated, alluding to the FDA’s proposed ban on use of indoor tanning equipment by people younger than 18.

The study presents the strongest evidence to date regarding the association between indoor tanning and Melanoma, said Skin Cancer Specialist Mary Maloney, MD, of the University of Massachusetts Medical Center in Worcester.

“This study definitively links suntanning in salons with the development of Melanoma,” Maloney told MedPage Today. “I just don’t think you can argue with the epidemiologic results here, showing that women with more sessions of tanning and earlier tanning have a significant increase in Melanoma over those people who didn’t engage in that behavior or started later.”

The authors of an accompanying editorial praised Lazovich’s group for providing “important additional support for this hypothesis” that indoor tanning is the cause of the increased Melanoma occurrence in young women; however, the editorialists argued that the FDA proposal focusing on age restrictions doesn’t go far enough, citing loopholes in other attempts to restrict minors’ access to tanning facilities.

The focus on age also overlooks a simple fact: “most indoor tanners are adults, with about 85% estimated to be 18 years or older and therefore unaffected by age restrictions among minors,” Gery Guy Jr., PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote. Possible means of deterring indoor tanning include school policies, restrictions on sales of tanning equipment to the public, and counter-advertising to address “deceptive advertising by the indoor tanning industry.”

Until recently, a well-recognized increase in Melanoma incidence in the U.S. included higher rates in women until approximately age 50, followed by increases in both sexes. About 20 years ago, a sex-related divergence emerged, as a female predominance became apparent. Over the past decade, Melanoma occurrence not only has remainder higher in women but has increased at a more rapid rate in younger women compared with men.

The latest epidemiologic trends have been associated with anatomical changes in Melanoma lesion location, as truncal predominance among women has shifted to localization to other sites, whereas localization on the head and extremities among women has shifted toward more truncal lesions in younger women but not older women, the authors noted. The change in disease localization relates, in part, to increased use of indoor tanning equipment.

Lazovich and colleagues previously reported a drastic increase in Melanoma risk amongst users of indoor tanning equipment as compared with people who did not use tanning facilities. The study also exhibited a strong dose-response relationship, as Melanoma risk increased with frequency of indoor tanning.

To update and inform previous observations, the authors analyzed data from the Skin Health Study to explore the relationship between Melanoma to use of indoor tanning, age at initiation of indoor tanning, and frequency of indoor tanning. They performed separate analyses for men and women.

The analysis featured 681 patients with Melanoma diagnoses in Minnesota during 2004 and 2007. Women accounted for 68.2% (465) of the total patient population. The patients were matched by age and sex with a control group of 654 Melanoma-free individuals.

The authors concluded that women younger than 40 began indoor tanning at a younger age compared with women 40 to 49 (16 versus 25, P<0.001) and reported a significantly higher median number of tanning sessions (100 versus 40, P<0.001). Women younger than 30 had a 6-fold greater possibility of being among the Melanoma cases than in the control group (OR 6.0, 95% CI 1.3-28.5). Women 30 to 39 were 3.5 times more likely to be cases than controls, and 40 to 49 were 2.3 times more likely. A dose-response relationship between frequency of indoor tanning and Melanoma risk was seen across all age groups of women.

The data on men were not as revealing, as the relationship between indoor tanning and Melanoma was inconsistent. In the cases and control group combined, substantially fewer men reported indoor tanning (44.3% versus 78.2%), which could explain much of the inconsistency, the authors noted.

Study limitations included a small sample size and wide confidence intervals, the authors stated. Additionally, the case-control study design and low response rates could elicit concerns about selection and recall bias.

Dr. Oleh Slupchynskyj treats patients suffering from Melanoma. Contact us today to schedule your consultation.

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