Meniscus and cartilage injuries, peripheral neuropathy, rotator cuff problems, sciatica, herniated discs, carpal tunnel, osteoarthritis.
The pain of these ailments can be eased by stem cell treatments, the man in the Holiday Inn hotel meeting room in Virginia Beach said at a free public seminar.
“We see lots of hips, we see lots of knees, of course shoulders and elbows,” said Jonathan Claar, with Virginia Advanced Medical clinic in Chesapeake.
For about an hour in late August, Claar talked about stem cells, peppering his pitch with stories of professional athletes and video testimonials from people saying the treatments made them feel better.
“We’re going to discuss regenerative medicine, more specifically, the stem cells. Where we get the stem cells from, some of the research behind them. We’re going to discuss the good, the bad, the ugly behind them, as well.”
He told the crowd of less than 50 older people about the other services his clinic offers, including a “vampire facelift” and erectile dysfunction treatments.
“But you guys are here to talk today, I think, to learn mostly about stem cells, because this isn’t a prostate seminar, correct?” he said to a few laughs.
The price advertised at the seminar? $6,497 per injection of a substance taken from umbilical cords that contains stem cells, or $9,997 for two. The injections aren’t covered by insurance, Claar noted at the seminar.
What he didn’t mention is that researchers say there’s no scientific proof that stem cell injections like the ones he was selling work the way he and other clinics across the country advertise. While doctors and regulators agree that stem cell science may eventually offer promising cures, only a few uses so far have been approved by the Food and Drug Administration.
Nonetheless, there’s been a surge in direct-to-consumer clinics offering stem cell treatments that aren’t connected to FDA-approved clinical trials and that exist outside the agency’s review. Some employers, through their insurance plans, have recently started to require workers visit a clinic before opting for expensive surgery. That growth has come despite recent regulatory threats including FDA injunctions placed on two companies and Google’s recent refusal to accept ads from stem cell providers.
The International Society for Stem Cell Research, a nonprofit group of stem cell scientists and doctors whose site is linked to by the National Institutes of Health, has said on its own website that nascent stem cell treatments, “while promising, are still at very early experimental stages.” As for the rapid growth of stem cell clinics selling treatments that haven’t undergone rigorous scientific testing, the organization has accused the industry of “preying upon suffering and desperate patients by falsely marketing their own stem cell ‘treatment’ as a silver bullet for any and all diseases, despite the absence of any scientific rationale supporting their approach and evidence of their safety or effectiveness.”
In his presentation, Claar said his treatments offer a better alternative to surgeries, which can involve painful recoveries and the potential for prescription drug addiction.
“We don’t want them to turn to opioids,” Claar reiterated to The Pilot recently, referring to prospective patients.
Critics say the stem cell treatments are scientifically unproven and pricey.
Leigh Turner, a professor with the Center for Bioethics at the University of Minnesota, and another researcher tracked the number of businesses and clinics in 2016 and counted 570 locations. Now, he estimates the number exceeds 1,000.
The companies operate in “regulatory gray zones,” he said.
There’s no proof the treatments work, Turner said of the direct-to-consumer clinics’ stem cell injections that haven’t been FDA approved or cleared for a clinical trial. “The evidence isn’t there,” he said, adding that there’s a large gap between “bold advertising campaigns and just the actual reality of the current state of stem cell research.”
“It’s placebo theater,” he said.
David Timm of Chesapeake was drawn to a Virginia Advanced Medical seminar in April by promises of a possible fix for the peripheral neuropathy that numbs his feet.
A salesman for years, he said he was won over by the seminar’s sales pitch. His feet go numb and cold, and he has nerve damage in his back, a bad right knee and inner-ear issues, he said. It’s hard for him to walk on uneven surfaces, and he said he worries about falls. The presentation, which was not led by Claar, gave Timm hope that he might find relief. Hope, he said, led him to agree to pay nearly $10,000, according to his records, to have each of his feet injected with a shot of Wharton’s Jelly, a substance from the cushiony material inside an umbilical cord that includes stem cells.
Claar noted in his August presentation that results typically take three to nine months, and the clinic’s website gives it a couple months. It was within that time, Timm said, that he read stories about other stem cell clinics that concerned him. His hope faded, he said. The injections hadn’t helped and he was on the hook for a hefty bill.
Deep in a consent form Timm signed, Virginia Advanced Medical asks the patient to affirm: “I understand that the Procedure is currently not traditional, conventional, accepted or proven, and that although peer-reviewed and published scientific research is available, little is known about long-term outcome and effectiveness.” Timm said that was never explained to him and he was encouraged to sign the paperwork quickly.
Timm said the financing for the treatment was pitched as having no interest. However, the loan to Timm, financed through GreenSky, a company that also covers home improvement loans, had a fixed annual interest rate of 26.99%, if he did not pay it off in full within 24 months, according to the loan documents.
“These are patients who are desperate,” said Kevin McCormack, director of patient outreach and public relations for the California Institute for Regenerative Medicine, a state-funded stem cell research agency. The promise of a “magical elixir” when conventional medicine doesn’t offer a cure can be irresistible, he said. His advice? Buyer beware.
He warned of three red flags to watch for when considering stem cell or regenerative therapy: the treatment isn’t covered by insurance, there’s no scientific evidence provided (just anecdotal testimonials), and the treatment is not part of an FDA-approved clinical trial.
Virginia Advanced Medical is among 34 clinics affiliated with Vitality Biologics, a company that distributes the products used in the treatments and assists with marketing.
In an email, Vitality’s co-founder, Kristofer Chaffin pointed to “many articles showing success in this field, as well as thousands of happy patients,” adding that he agreed that more scientific studies should, and were, being done.
“Does it work for everyone? No, nothing in medicine does,” he said of the treatments.
During his hotel conference room talk, Claar said the treatments offered by Virginia Advanced Medical were derived from donated umbilical cords from healthy Caesarian deliveries, “all natural stuff.”
In his presentation, Claar said he assumed the crowd was wondering: “Is this product that you’re using, is it FDA approved?”
“So the FDA has no jurisdiction over natural things,” he said. “That means it can’t regulate your blood, your hair, your urine, that’s your stuff.”
“So, this is a natural product for homologous use. It’s classified as a section 361,” he said, citing an FDA exception that allows some human cells, tissues, and cellular and tissue-based products to be sold without having to undergo clinical trials or FDA review. “If you were to take this product and we added a pharmaceutical agent to it, that changes the classification to section 351, that’s different, we’d have to go through FDA approval.”
The FDA has warned consumers about that characterization.
“You may be told that because these are your cells, the FDA does not need to review or approve the treatment,” the agency has announced. “That is not true.”
Claar said recently in a phone interview that he was alluding to the exemption in FDA regulations that allow for the development of stem cell and tissue products that are minimally manipulated and perform the same basic function in the recipient as in the donor (think skin transplants), without the need for the FDA’s review of the product before it is sold.
“The FDA does indeed regulate natural products but I was referring to our body fluids not having regulation based off the 21 CFR 1271,” he said in an email, referring to the regulatory code that governs human cells, tissues, and cellular and tissue-based products. “We are not utilizing the patients’ own cells anyways so it does not pertain to us. We offer placental human tissue allografts known for their structural properties.”
After The Pilot pointed out that his presentation never made mention of “placental human tissue allografts” and was almost entirely spent discussing stem cells, he said in another email, “We don’t necessarily say we treat with stem cells ‘exclusively or by themselves,’ as there are many other substances which are present in the allograft.”
In September, the FDA sent a warning letter to a California company, unrelated and unconnected to the Chesapeake clinic, saying that two of its products, including one derived from Wharton’s Jelly, that were being marketed as a solution for arthritis and to speed up the “healing process” were not being used to perform the same basic function in the recipient as in the donor. The umbilical cord material wasn’t being used as a conduit, as it had been for the donor, the agency said.
“We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true,” said Acting FDA Commissioner Ned Sharpless, M.D., in a statement announcing the warning letter. “Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”
The injection Timm received was a CoreCyte Wharton’s Jelly Allograft that came from Predictive Biotech Inc., according to his records.
That product, like all others that fall under the FDA’s exemption, aren’t required to conduct clinical trials but also cannot claim to have the FDA’s stamp of approval as far as safety and efficacy. Claar said his clinic has since switched from using Predictive Biotech’s products to using Signature Biologics’ products instead.
Claar said he was unaware of the circumstances surrounding the FDA’s warning to Stemell, the California company, and defended his clinic’s use of Signature’s Wharton’s Jelly product, saying it did perform the same function in patients as it did in the umbilical cord because it acts as the “supportive tissue.”
“It’s performing the function for cushioning,” he said.
Turner, with the Center for Bioethics, though, said the clinics are putting the cells in parts of the body where they don’t normally occur and asking them to behave differently. In the case of Virginia Advanced Medical, umbilical cord material is being injected into older, pained joints, he said.
The FDA advises consumers to ask a provider if the treatment has been reviewed by the agency and if there’s an “investigational new drug” application number. The director of sales for Signature Biologics said in an emailed response to The Pilot in late October that the company had no active filings under the FDA’s investigational new drug program, at that time. The company said it’s complying with regulations under the exemption.
Claar told The Pilot that “We’re doing everything we can as far as following guidelines,” and cited the “litany of research” backing up his use of the products on his clinic’s website. He said he understands the treatments are controversial, but “insurance will eventually come around to it.”
Claar cautioned his seminar audience with a disclaimer. “Folks, this is not a cure-all. We want happy patients.”
The people at the seminar were asked to yell out what they miss doing most. They called out things like golfing, walking and hiking. And sleeping.
“We want those things for you, too. We want you guys to live your life on your terms,” Claar said, before queuing up a short movie comparing an aging person living a happy life and one rapidly dying. The narrator asked: “Will you grow old with vitality, or (get) old with disease.”
Timm said he eventually sat down for a talk with Claar, whom Timm described as sincere. He had Timm’s debt expunged and his payments refunded, Timm said. Claar did not respond when asked about the refund.
After spending several months researching the often nebulous commercial stem cell industry, Timm had scrawled “DONE!” in all caps, underlined and with an exclamation point, across one of his latest bills for the treatment.
Timm said he worries about others seeking a fix to their ailments who may not be so lucky, so he’s continued to warn anyone who might listen about the stem cell industry in general. He still suffers from his foot numbness, and knows how tempting the sales pitch is to others like him.
“This is a last resort for them,” he said.
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Stem cell science
Most cells in the body can divide to create only a copy of themselves. Muscle cells create more muscle cells, for example. Stem cells, however, can divide to create more stem cells, but also can mature to become any type of tissue and organ in the body.
The two main types of stem cells are embryonic and adult stem cells. The embryonic stem cells used in research come from unused embryos from in vitro fertilizations that have been donated to science. Embryonic stem cells are called “pluripotent,” because they can turn into many other types of cells.
Adult stem cells generally come from developed tissues, such as bone marrow, and tend to generate either more stem cells or more cells of that tissue.
Scientists can create another type of adult stem cell, “induced pluripotent stem cells,” that have some of the characteristics of embryonic stem cells.
Scientists have found that stem cells from the placenta and umbilical cords of newborn babies have the properties of adult stem cells, according to California Institute for Regenerative Medicine.
The FDA has approved only a few stem cell treatments, and they use umbilical cord blood to treat blood cancers and immune diseases. Just three gene therapies have been approved, two for cancer and one for genetic blindness. Only 17 cellular and gene products have the FDA’s approval.
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Direct-to-consumer stem cell companies
With the commercial stem cell industry’s swift growth, it can be a challenge to determine who is behind what, with infighting even among the various companies, suppliers and clinics involved.
In Virginia Advanced Medical’s case, The Pilot connected the dots after watching Jonathan Claar’s presentation during which he introduced himself to the small crowd as a “host” and said he does patient evaluation and education “with the clinics that I work with.”
He said the clinic was part of the “Vitality” network. “We are a sister clinic, we are an associated, affiliated clinic with Vitality that has about 34 clinics nationwide.”
What is Vitality?
Vitality Biologics is a marketing consultant and product distributor, and the clinics are independently owned and operated, according to Kristofer T. Chaffin, who said he’s a co-founder. Many of the 34 clinics affiliated with Vitality Biologics share patient testimonial videos, talking points and research on their websites.
Chaffin said in an emailed response to The Pilot: “We strive to help clinics be compliant and market accordingly.” He said Vitality Biologics stays up to date on FDA guidelines. “We will happily adapt to any guideline changes in the future if deemed necessary by any regulatory agency. There are plenty of bad apples in this industry, we are committed to doing things the right way.”
According to an October 2016 article in The Sacramento Bee, Chaffin was selling stem cell treatments in hotel conference rooms on behalf of now-closed Nervana Stem Cell Center. Chaffin – a licensed chiropractor in Georgia who identifies himself on his personal website as a doctor, entrepreneur, family man, consultant and philanthropist – told The Pilot that he didn’t work for California-based Nervana, he just helped with advertising.
Claar told The Pilot that Virginia Advanced Medical has also been affiliated with Advanced Medical Integration, a separate and unrelated consulting firm that trains chiropractors to expand their practices with other staff and services such as stem cell therapies.
Who owns Virginia Advanced Medical?
Claar, a licensed chiropractor, lists himself on LinkedIn as manager of Virginia Advanced Medical and another clinic, Ohio Advanced Medical in Dublin, Ohio. He didn’t mention it in his presentation, but confirmed later that he owns both clinics.
The brochure distributed at the seminar by Virginia Advanced Medical prominently features the biography for Neil Riordan of the Panama-based Stem Cell Institute, somewhat of a celebrity in stem cell circles who has written books and appeared alongside actor Mel Gibson to talk about stem cells. His company, Signature Biologics, partnered with Vitality Biologics in June to supply its products to the clinics, according to a press release from the latter.
