Stem cell clinics in Arizona offer unapproved, unregulated treatments
I can’t tell you the exact truth that it makes it better. But in my mind, it’s not going to hurt.
“It’s trying to show how well this works, under what conditions. … So we can show that what we’re doing is is beneficial to the patients,” DeWald said. “And then the last thing is obviously to report any negative outcomes to avoid harm for the patients.”
The data can help doctors figure out what types of treatments to do and help standardize the field of regenerative medicine, DeWald said. Another hope is that the data could be used to help get such treatments approved and covered by insurance companies, he said.
The data is collected through a phone app and relies on self-reported information from patients. According to DataBiologic’s website, the company is collecting data from 43 different clinics and has data on more than 3,000 patients.
Though the field of regenerative medicine is relatively young, DeWald said he offers stem cell treatments to provide patients options beyond surgery.
“From the research and the data that I’ve seen and experienced myself, it’s not harming patients. Overwhelmingly, the evidence is that it’s helping patients,” he said.
Some of the diseases targeted by stem cell clinics don’t have any good existing cures or treatments, meaning that patients may be more willing to try an unproven, experimental approach, according to ASU’s Frow.
“They are sort of chronic conditions that people end up having to live with and manage as best as they can,” Frow said. “Oftentimes, these are conditions that creep up on you a little bit later on in life as well.”
The two most common types of conditions targeted by stem cell clinics are inflammatory and orthopedic conditions, according to the 2019 study Frow worked on with ASU researcher David Brafman.
Frow speculated that areas with older, richer communities may have emerged as stem cell clinic hot spots because these conditions often affect older people and because treatments are uninsured and expensive.
Out of 238 clinics found in a Republic investigation, nearly a quarter of them are in Scottsdale.
According to Census Reporter, a nonprofit research tool that compiles data from the Census Bureau’s American Community Survey, Scottsdale’s median age is 50.1, higher than the nationwide median age of 38.5. The median household income in Scottsdale is $86,097, higher than the median household income nationally of $65,712, according to Census Reporter.
The second largest number of clinics was found in Phoenix, followed by Gilbert and Mesa.
The Republic analysis also found that most of the clinics did not focus on stem cells as a main part of their practice. A majority, roughly 84%, offered stem cells as one of many treatments available.
In these cases, common focuses included orthopedics, chiropractics or holistic medicine.
In Brafman and Frow’s research, only 25% of stem cell businesses in the Southwest solely focused on stem cells. Such clinics were more likely to use stem cells for a wide range of condition types, which the researchers said is a possible warning sign that the business is not acting responsibly.
When a business claims to treat a wide variety of conditions, Brafman said their research showed it’s less likely that the health care provider at the business has been trained in the area they are practicing in.
Brafman said that raises concerns for him as a stem cell researcher because the way stem cells work to treat one disease may be different than another and may require different techniques.
“There should be no one-size-fits-all,” he said.
The Republic analysis found several clinics that list over 30 different health conditions to be treated with stem cells and found 11 clinics claiming to treat 20 or more different conditions across a wide range of specialties.
Among the conditions the clinics claimed they could treat: COVID-19, autism, arthritis, tendinitis, lung disease, diabetes, cancer, heart disease, Alzheimer’s disease and amyotrophic lateral sclerosis, or ALS.
Though Harris said he has seen incidents of treatments offered by nonmedical personnel, almost all stem cell providers found in The Republic’s investigation could claim some sort of health care qualification.
Even among clinics that only offer stem cells, Frow and Brafman’s research found that 60% of providers at such clinics held medical licenses. Only 7% of providers held either just a graduate degree with no medical qualifications or an unspecified qualification.
Medical qualifications can include a medical doctor license, doctor of chiropractic license, naturopathic doctor license, nurse practitioner license or physician’s assistant license.
Even with medical qualifications, some stem cell providers are operating outside their scope of knowledge or area of specialty, according to Brafman, Frow and Turner. Medical practices require specialized training to operate on the brain versus operating on the heart, and Brafman thinks stem cell treatments shouldn’t be any different. To do a stem cell procedure in the lungs for example, he said doctors should have specialized knowledge of pulmonary care.
Frow said their research showed that orthopedic specialists and sports medicine doctors were the most likely to treat conditions within their area of expertise, while plastic surgeons often treated a wide range of medical conditions that were not related to the field of plastic surgery.
This should be another red flag for consumers, she said.
“If you really think that stem cells are the right thing for you, then maybe you want to think about a clinic that … has some real expertise in that area,” she said.
In a 2019 study, Turner wrote that health care providers practicing beyond their scope of training could increase risks to patients.
Frow said doctors also need specialized knowledge of stem cells treatments. Stem cell science and its potential medical applications are taught in some medical schools, but there’s no standardized stem cell curriculum across the country, according to Zubin Master, who researches stem cell ethics and policy at the Mayo Clinic in Minnesota.
He said creating proper training protocols for stem cell treatments is now being discussed in the medical community.
One potential option could be requiring some sort of fellowship in stem cell and regenerative medicine.
Instead of receiving formal training, Harris said doctors or other health care providers usually sign up for unofficial stem cell training sessions, which often only last a few days.
“Most of these guys don’t have a clue because this is not their field of expertise,” Harris said. “They’ve attended a couple of weekend seminars … where they’re told that doing this will increase their practice income by 25% or more.”
These training sessions are limited, according to Harris, and only go over the basics of stem cells.
One stem cell training course is offered by R3 Stem Cell, an Arizona company founded by former doctor David Greene. The company is not a clinic or a stem cell product manufacturer, but it acts as a liaison between manufacturers and clinics to set up training and assist with product distribution, Greene said.
On the first day of R3’s training course, Greene said, students learn about stem cells, marketing, social media and how to use appropriate disclaimers. On the second day, Greene said attendees can learn how to perform stem cell procedures.
The 2020 two-day training sessions were available either in person or via livestream, according to R3’s website. It said the session could teach doctors musculoskeletal, neurologic, autoimmune, sexual and aesthetic stem cell procedure techniques.
But while it’s fairly easy to learn how to do stem cell injections, that doesn’t mean doctors are doing treatments correctly, Harris said. Getting stem cells to turn into the right type of cells needed is a complex process that scientists in Arizona are still researching .
Greene acknowledged that it can be difficult to understand what stem cells will turn into, but claimed the body naturally tells stem cells what it needs.
“It is not necessarily random where the biologics goes,” he said. “Your body is giving off inflammatory signals and other messages that say, ‘hey, I need some help here.'”
The danger of offering uncontrolled treatments is that stem cells could travel to the wrong area of the body and could potentially turn into cancer, Harris said.
Greene said he only works with products he feels are safe. He also claims the clinics affiliated with R3 Stem Cells have collectively treated over 15,000 people with an 85% patient satisfaction rate. He did not provide The Republic a detailed record or proof of this data upon request, citing federal health information privacy rules.
“Our patient data is proprietary per HIPPA,” Greene wrote in an email. “With regards to patient satisfaction … we keep that data confidential/blinded unless specific patients agree to let us use their testimonial.”
Greene does not directly administer treatments or work with patients in a medical setting. He lost his license to practice medicine in 2009, according to a state medical board order.
Greene deviated from the standard of care in at least 10 cases, including care for three patients who died, according to a medical board order.
One of his patients was Lola Ollerton, a 78-year-old woman Greene operated on in 2006.
After the surgery, one of Ollerton’s daughters, Peggy Archuleta, remembers that she, her four sisters and her father were pulled into a consultation room. Greene told them there was a serious problem, she recalled.
Archuleta said she kept waiting for doctors to tell her how they fixed the problem.
Instead, she learned that her mother had died.
“I remember watching my father and I saw his face go down in his hands and he just started to sob,” she recalled.
Later on, she found out about the other cases.
“That’s what bothers me,” Archuleta said. “If I had some sort of a specialty and I had frequent bad outcomes, I would do something about it. I wouldn’t just continue to make mistakes.”
Following reports of patient deaths, the Arizona Medical Board asked Greene to inform them of any other surgical complications, according to the board order. Greene only provided them information on some of the cases, which he attributed to a communications mix-up.
The board order also stated that Greene continued to insist he made no mistakes and that he scored in the lowest percentile on ethics and communication hen he participated in a physician assessment program.
Despite the fact that Greene lost his medical license, he still uses the title “Dr.” on his company marketing and in his emails.
Greene defended his use of the title doctor, asserting that he had completed years of education and that plenty of people on TV call themselves doctors without practicing medicine or having a medical license.
“I’m not going to sit here and argue about my honesty and trustworthiness,” he said.
If Archuleta had known ahead of time about the other complaints against Greene, she said her family may never have trusted him with her mother’s surgery.
Greene isn’t the only doctor in the stem cell industry to be disciplined. The Republic’s investigation found additional board actions against 27 other health care providers in the stem cell industry.
Allegations that resulted in board actions included operating while intoxicated, patient death, patient harm, substance abuse, prescribing drugs improperly, false advertising, inadequate medical record keeping and sexual harassment.
The FDA issued a warning letter in 2019 to R3 Stem Cell accusing it of marketing unapproved stem cell treatments.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients,” then-FDA Acting Commissioner Ned Sharpless said in a May 2019 statement about the action.
Greene said the FDA sent the letter in part because it thought that R3 Stem Cell was a lab manufacturing or processing tissue, which Greene said it is not, and in part because of the way the company was marketing the products.
“We had a lot of pages on our website of conditions and on those pages, we had a lot of research studies listed that were either animal or human or both, but we didn’t sit there and say that it could definitively help,” Greene said. “We weren’t actually making claims.”
Now, the company simply has a page under its “conditions” tab titled “disease awareness,” which lists various conditions and descriptions of those conditions. Since making this change, Greene said he has not heard from the FDA.
In its warning letter, the FDA stated that the products marketed by R3 Stem Cell appear to be products that are subject to regulation and that to lawfully market the products, the company needed an approved biologics license from the FDA.
A Republic analysis of 238 stem cell clinics in Arizona showed that multiple clinics advertised free informational sessions or educational sessions. Such seminars appear to be an effective way for clinics to recruit new customers, according to an analysis by Paul Knoepfler, a biologist and professor at UC Davis School of Medicine who studies stem cells.
He wrote in his analysis that the experience of personally attending one seminar “felt more like attending a persuasive entertainment show or something on a television shopping network than an educational seminar.”
He described the seminar as an opportunity to make a “hard sell,” to attendees and described some of the medical claims made at the seminar as questionable, while also noting that no disclaimers were made.
These types of seminars are often aggressive marketing spiels that target elderly people, according to Turner.
“The goal is to get their name, their email, their phone number, and then put some kind of offer on the table and get them to commit on the spot,” Turner said.
Glowing reviews and testimonials from patients are another powerful tool used to market stem cell treatments, according to Master, the Mayo researcher. He said stories from past patients can easily spread misinformation.
“Narratives are very effective at influencing people’s health behavior,” Master said. “A story may last longer than statistical information about evidence.”
Using patient testimonials can allow a provider to cherry pick the best outcomes, Master said.
In a 2019 study, Master analyzed 159 online patient testimonials of stem cell therapies and found that patients mentioned benefits in 95% of the videos but only mentioned risks in about 10%. In videos mentioning risk, Master wrote that in all but one, risks were “underemphasized.”
Master said he and others in the scientific community suspect these testimonials are likely filmed right after a treatment is administered, without following up on whether the treatment was successful in the long term.
Most businesses that market unapproved stem cell treatments don’t collect and publish data on how safe or effective treatments are, according to Turner, which he said makes it difficult to understand the risks of treatments.
In his research, he found that risks can include lesions, tumors, blindness and financial harm. He also found that stem cell businesses don’t always give consumers accurate information about their treatments, which he argues impedes consumers’ abilities to make informed decisions.
He found that certain marketing strategies used by stem cell companies exaggerated the likelihood of benefits while failing to adequately disclose risks.
“If you’re told that there really aren’t side effects or that there’s really no risk involved, that’s a bit of a red flag,” ASU’s Frow said.
To add an air of legitimacy to their treatments, Turner said clinics may also state that their products come from FDA regulated facilities or are somehow regulated. But that does not mean the treatment itself is FDA regulated or approved.
In many cases, Harris said, stem cell providers may obtain stem cells from third party sources, such as umbilical cord banks, but may not actually know what’s in them.
His lab ordered stem cell products from companies selling them and independently analyzed products to find that some stem cell products don’t actually contain stem cells, he said.
But doctors offering stem cell treatments may be unaware of this fact, Harris said, because they are not trained in the field of stem cell medicine.
“They do no testing so they can’t tell you what they bought,” Harris said. “And they really don’t know how to address any side effects that that might occur.”
Orthopedic surgeon Salvatore LaCognata performs stem cell procedures at Valley Bone & Joint Specialists in Maricopa County using third-party products that he said he checks thoroughly.
On its website, Valley Bone & Joint Specialist says its stem cell procedure involves a bone marrow extraction, but LaCognata said he uses products derived from birth tissue in his stem cell procedures.
LaCognata acknowledged that there are some “buyer beware” situations in his industry where patients don’t always know what they’re getting in stem cell treatments.
While anyone can obtain these products and use them, he said he believes that it’s important for stem cell doctors to learn to differentiate products from each other.
“To truly use it responsibly and know what you are delivering, both in product and potential to your patient, I think you need to be as educated as you can be in the material that you’re using,” LaCognata said. “And sometimes just looking at a research paper doesn’t always give you a full picture.”
When selecting which products he will use, LaCognata said he speaks to vendors and asks for detailed information from manufacturers. He said he visits the facilities where the tissues he buys are processed.
“I see what they do. I see how they handle the tissue,” LaCognata said. “I looked under the microscope and have them show me why their material is valuable or proliferative or whatever their claims may be.”
LaCognata said he tries to use the products responsibly, as an additive treatment to standard care rather than as a replacement for it. In his practice, he said he uses stem cell treatments to help patients recover after a knee or hip replacement as well as to help heal some wounds.
The lack of standardized procedures or established protocols makes it hard to know what to expect when administering it to patients, he said. He still believes stem cell products and treatments are worth doing.
“I have not done any studies and I don’t plan to do any studies,” he said. “I don’t need a study to convince me, and I don’t need to convince anybody else about the efficacy and the biologic potential that allografts have. I do believe in their potential. … What we have to do is use it responsibly.”
LaCognata said the manufacturers that make the products he uses have given him every indication they are working with the FDA requirements.
DeWald said he believes getting stem cells from an outside source could pose a risk to patients and said many of these products are not likely to have stem cells in them due to the way that the products are frozen and thawed.
With cord blood banking, DeWald said, the thawing process can take a few days. The instructions for thawing out stem cell products often say to warm up and thaw the product in your hands within minutes.
“That whole process basically kills all the cells,” he said.
He also cited a study by Lisa Fortier, a Cornell University regenerative medicine researcher, which analyzed nine birth tissue derived products and found no live cells in any of them.
Those using umbilical cord blood stem cell products tend to also be the ones marketing it as a treatment for a wide range of conditions, DeWald said, “which is kind of disconcerting.”
There are allegations that some stem cell products were contaminated in the past. In December 2018, the Centers for Disease Control and Prevention issued a report connecting 12 cases of E.coli infection in multiple states to stem cell treatments sold by a California-based company called Liveyon.
The company recalled the product after these infections, but the infections sparked numerous lawsuits, including one from an Arizona patient, which was settled with a payout to the patient.
There is also a huge gap between current stem cell research and the marketing claims made by unapproved stem cell treatment providers, according to Turner.
“They don’t have anything scientific to offer, but they are tapping into human suffering,” Turner said.
Despite discrepancies, he said many clinics link to stem cell studies and research papers, hoping to capitalize on the hype over stem cell research.