Stem cell clinics in Arizona offer unapproved, unregulated treatments

Stem cell clinics in Arizona offer unapproved, unregulated treatments


Orthopedic surgeon Eric Eifler, who does stem cell 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.

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

A health care provider in Scottsdale injects a patient during a stem cell treatment.

A health care provider in Scottsdale injects a patient during a stem cell treatment.
Amanda Morris/The Republic

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.

Stem cells are the cells that develop into organs, blood, brain and bones.

Stem cells are the cells that develop into organs, blood, brain and bones.
Getty Images

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.

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.

Leigh Turner, University of Minnesota researcher
They don’t have anything scientific to offer, but they are tapping into human suffering.

Often, Arizona scientists said, these research papers don’t match up to the treatment being offered, meaning they don’t actually offer any scientific support for what providers are doing.

“There’s a lot of quackery,” Harris said.

Out of about 380 studies mentioned by various stem cell businesses, Frow said a student on her research team found that only six actually provided direct, clinical evidence for the treatments being offered by the businesses.

Another practice, according to Harris, is telling patients that the treatments are part of a study or clinical trial, which he said is often a false claim. Or, he said, clinics may ask clients to pay thousands of dollars to participate in a trial, which is a red flag.

“Experimental trials don’t require you to experiment with your bank account at the same time,” he said.

He argued patients participating in unofficial studies are less like guinea pigs and more like sacrificial lambs, because even in guinea pig experiments, data is usually collected in order to advance scientific knowledge. 

In these studies, he said little to no data gets published.

Some clinics register studies on, an online database of clinical trials run by the National Institutes of Health, which may give the appearance that these clinics are regulated by the FDA and are conducting scientific research, but Master said that’s not always the case.

“There’s very little monitoring,” Master said. “It’s a repository of information that’s not being overseen and pretty much anybody can (register a study).”

In this way, could serve as another marketing platform to make it seem as though a clinic has been legitimately checked and approved by a government agency, Turner said.

In his research on unregulated stem cell clinics, he has found studies listed on that charge participants $7,500 to $20,000 or more.

Of 152 stem cell businesses in Arizona, only three had listed studies on

Of 152 known stem cell businesses in Arizona, only three have listed stem cell studies on

Of 152 known stem cell businesses in Arizona, only three have listed stem cell studies on
Amanda Morris

The challenge that regulators face is figuring out how to get the industry under control, Turner said. Tales of botched stem cell treatments or warnings from the FDA and stem cell scientists seem to be doing little to curtail the industry’s growth.

“I could get up on my soapbox and tell people not to go to these places, but scientists have been doing that for decades and these clinics are still here,” Brafman said.

Brafman and Frow hope to use their research to help better inform patients who may be considering treatment. 

There are ongoing efforts by organizations such as Mayo Clinic and the International Society for Stem Cell Research to increase consumer awareness and education around stem cells. The society has published a list of questions that patients should ask before considering stem cell therapy.

For more specific advice, Mayo Clinic offers a regenerative medicine consult service that tries to match patients with existing research studies or clinical trials and counter any misinformation a patient may have heard.

“They may have not wanted to hear the type of information they were getting, but they were very happy that they got it straight,” Master said.

While he said many efforts to combat stem cell clinics have focused on regulations, laws and enforcement against the clinics themselves, he believes not enough work has been done to educate consumers about stem cells.

Master also said that individual lawsuits or class-action lawsuits with multiple plaintiffs are good tools to raise awareness about the dangers of unproven stem cell treatments.

But his research has shown that most individual lawsuits end in settlements, which aren’t as effective for raising consumer awareness.

While paying for settlements might hurt one business financially, some settlements require patients to sign non-disclosure agreements to get the money, so victims aren’t able to speak out publicly about their experiences, he explained. He believes this secrecy limits the ability for lawsuits to raise consumer awareness.

Another approach is to more aggressively punish actors in the industry.

The FDA has been issuing warning letters to stem cell businesses for years, and has taken actions to shut some businesses down, but Turner said this response has been largely reactive, with the FDA taking the most action after damage is already done.

In Turner’s opinion, the agency’s actions have come too late.

“I think there was a moment a decade ago … where the FDA could have dedicated limited resources and quite effectively curtailed the ambitions of this marketplace, and that didn’t happen,” he said. “Now it’s going to be very difficult to alter the existing landscape.”

He added that a few warning letters and court injunctions wouldn’t be effective and thinks the agency needs to have a more effective regulatory response.

FDA spokesperson Stephanie Caccomo, told The Republic that the agency wanted to encourage businesses in the industry to work with them to get under compliance and would like to help “facilitate innovation.”

Caccomo acknowledged that some of the treatments had risks and said the FDA will “continue efforts to take appropriate enforcement action against those who market products with unproven claims of therapeutic benefit which are misleading and deceptive.” 

She did not respond directly to questions about whether the FDA lacked resources necessary to clamp down on the industry. 

But, Turner added, it’s not just up to the FDA. He said he would like to see a more robust response. For example, the Federal Trade Commission could take more action against misleading advertising claims and state medical boards could revoke licenses for doctors who are offering unregulated, unapproved treatments.

Arizona Medical Board Executive Director Patricia McSorley told The Republic that the board is complaint-driven and that any complaints will be investigated by the board.

“If the care or treatment provided is determined by the medical reviewer to be outside the standard of care, the matter will be reviewed by the Board,” McSorley wrote in answer to questions.

Independent coverage of bioscience in Arizona is supported by a grant from the Flinn Foundation.




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