The Vaccine as Fire Hose

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The vaccine news continues to seem very encouraging. Britain started its mass vaccination effort today, and the U.S. isn’t far behind.

But there is still one dark cloud hanging over the vaccines that many people don’t yet understand.

The vaccines will be much less effective at preventing death and illness in 2021 if they are introduced into a population where the coronavirus is raging — as is now the case in the U.S. That’s the central argument of a new paper in the journal Health Affairs. (One of the authors is Dr. Rochelle Walensky of Massachusetts General Hospital, whom President-elect Joe Biden has chosen to run the Centers for Disease Control and Prevention.)

An analogy may be helpful here. A vaccine is like a fire hose. A vaccine that’s 95 percent effective, as Moderna’s and Pfizer’s versions appear to be, is a powerful fire hose. But the size of a fire is still a bigger determinant of how much destruction occurs.

I asked the authors of the Health Affairs study to put their findings into terms that we nonscientists could understand, and they were kind enough to do so. The estimates are fairly stunning:

At the current level of infection in the U.S. (about 200,000 confirmed new infections per day), a vaccine that is 95 percent effective — distributed at the expected pace — would still leave a terrible toll in the six months after it was introduced. Almost 10 million or so Americans would contract the virus, and more than 160,000 would die.

This is far worse than the toll in an alternate universe in which the vaccine was only 50 percent effective but the U.S. had reduced the infection rate to its level in early September (about 35,000 new daily cases). In that scenario, the death toll in the next six months would be kept to about 60,000.

It’s worth pausing for a moment on this comparison, because it’s deeply counterintuitive. If the U.S. had maintained its infection rate from September and Moderna and Pfizer had announced this fall that their vaccines were only 50 percent effective, a lot of people would have freaked out.

Biden’s task force explores legal status for separated migrant families. It could get complicated.

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For the thousands of migrant families who were separated at the border by the Trump administration, the remedy that has eluded them thus far may soon be in sight: a pathway to legal status in the United States, with their loved ones at their sides.

That possibility is just beginning to be explored by a task force created last month by President Joe Biden, who has called the separations a “moral and national shame.”

The task force’s primary focus is to reunite the more than 1,000 families who remain apart, most of them separated by international borders. The new Department of Homeland Security secretary has promised to allow deported parents to reunite with their children in the United States — a concession that the Trump administration had refused.

“And if, in fact, they seek to reunite here in the United States,” Secretary Alejandro Mayorkas said Monday, “we will explore lawful pathways for them to remain in the United States and to address the family needs so we are acting as restoratively as possible.”

But what those pathways might look like — and how lasting they would be — remain entirely unclear.

The task force will likely examine a playbook of presidential powers that allows the executive branch to parole certain immigrants back into the country and provide sanctuary. But such relief, likely achieved through a mix-and-match approach, would be temporary and could be complicated by standing immigration court orders.

U.S. Border Patrol agents ask a group of Central American asylum seekers to remove hair bands and wedding rings before taking them into custody on June 12, 2018, near McAllen, Texas. The immigrant families were then sent to a U.S. Customs and Border Protection processing center for possible separation under the Trump administration’s “zero-tolerance” policy. (Getty Images)

Inserting families back into the overburdened and capricious immigration court system to restate their asylum claims is another option — one that immigrant advocates are adamantly discouraging.

“In the end they could be no better off. We are just kicking the can down the road,” said Jeremy McLean, policy advocacy manager for Justice in Motion, a New York-based nonprofit that has helped search for parents. “It’s also retraumatizing. If possible, we would like to have these families not go through that again.”

While the affected families have received a collective wave of publicity for the brutality they endured, their numbers are relatively small considering the roughly 1.3 million immigration cases pending as of January, according to the Transactional Records Access Clearinghouse.

The task force has also so far been silent on how wide a net it will be casting in its effort to make amends.

In all, some 5,400 children were separated by the Trump administration — many who were reunited with their parents under a San Diego court order and are now back in their home countries, as well as others who were barred from reuniting due to their parents’ criminal records. Will the task force afford these families the same opportunities for legal status?

“I really want this task force to not be centered on each individual case, whether or not they fit certain criteria,” said Carol Anne Donohoe, a managing attorney for Al Otro Lado, a nonprofit providing legal and humanitarian support to immigrants. “The only criteria they need to fit is ‘Were they or were they not separated from their child?’ and ‘Did we or did we not torture them?’”

Unraveling chaos

When the Trump administration decided to separate migrant families under a “zero-tolerance policy” in an attempt to clamp down on asylum-seekers at the border, it did so without any making any provision to reunite them.

Children were sent to government shelters while their parents were placed in federal criminal custody or civil immigration detention, or both. There was no central database tracking their movements. Parents often had no clue where their children, some just months old, had been taken, and visa versa.

Their immigration cases also branched, sending parent and child through different processes.

The zero-tolerance policy had been widely in effect across the southwestern border for about two months when U.S. District Judge Dana Sabraw, in a June 26, 2018, preliminary injunction, ordered families to be reunited within 30 days. His order, stemming from a lawsuit filed in San Diego federal court by the American Civil Liberties Union, focused on a known entity — a group of some 2,800 children who were in government shelters at the time.

Matching the children with their parents was an enormous undertaking, made somewhat simpler in that many of the adults were still in U.S. immigration detention. Some 2,000 families were reunited.

However, the effort revealed about 400 parents had already been deported. The Trump administration refused to allow the parents to reunite in the U.S. — a decision that the court upheld.

David Xol-Cholom of Guatemala hugs his son Byron at Los Angeles International Airport in January 2020, as they reunite after being separated during the Trump administration’s separation of immigrant families. (ASSOCIATED PRESS)

“The Trump administration gave families only two brutal choices: to remain separated from their child or bring their child back to the very danger from which they fled,” the ACLU’s lead attorney on the case, Lee Gelernt, told the Union-Tribune.

Most parents chose to leave their children safely in the U.S. with sponsors to pursue asylum.

Just as the reunification effort was wrapping up, another revelation dropped: Potentially hundreds if not thousands more families had been separated as part of an undisclosed pilot program in Texas a year earlier.

Sabraw ordered a full-throttle effort to identify and locate this new group, a tally that came to about 1,500 children. The endeavor was significantly more challenging due to the passage of time and lack of centralized records. By then, the children had been placed with sponsors, and the vast majority of parents had been deported.

Volunteers began the painstaking process of making contact, often equipped with nothing more than old addresses or phone numbers.

On-the-ground outreach by nonprofits in Central America resumed, with volunteers navigating difficult conditions and a deep-seated mistrust in government. Then it was sidelined by the unthinkable: a deadly pandemic.

As of Feb. 26, the parents of 499 children have yet to be located, while contact has been made with the parents of another 699 children. None have been officially reunited, although attorneys believe some parents have secretly rejoined their children in the U.S.

An additional 1,000 children have been separated since the June 2018 order. The Trump administration defended those cases, citing parental criminal records or doubts as to parentage.

Making amends

The entrance of Biden’s Interagency Task Force on the Reunification of Families into the situation at this point has re-energized the marathon effort to untangle the chaos of the previous administration. The task force is overseen by Michelle Brané, a noted immigration expert and longtime advocate for human rights, and includes DHS, the State Department, the Department of Health and Human Services and the Department of Justice.

Offering legal status in the U.S. would go a long way toward repairing the trauma of separation, said attorneys working with the families.

“For the most part, the reasons that families left their homes — none of that’s changed,” said McLean of Justice in Motion. “Given the opportunity to come to a safe place with their family, most would probably jump at that.”

Attorneys had tried to make it happen to some degree as part of the litigation. The effort ended in a limited settlement agreement for parents still in the U.S. to get a second shot at their asylum claims.

Only three parents and four children have been granted asylum under the settlement as of January, according to court records.

In a recent court hearing, Sabraw acknowledged the presidential powers that could transform the case.

“The executive branch is in the best position by far to rectify this situation,” he said.

But it is unclear how widely those powers may be flexed.

When asked for details on the scope of the task force’s efforts, the White House referred inquiries to DHS, which did not return a request for comment.

Bringing parents who were returned to their home countries back to the U.S. would probably be the easy part, with the government’s blessing and assistance, according to immigration experts.

The president has the authority to offer humanitarian parole to certain migrants for specific reasons, such as a child with a severe medical condition or a group of people fleeing specific harm. The Carter administration paroled Cubans into the U.S. in the early 1980s, for instance.

But parole merely gets the parent through the front door.

Attorneys have suggested the possibility that the executive branch then use its powers of deferred action to provide relief. While presidents have a duty to enforce immigration laws, they can also decide how to best enforce them, such as prioritizing the removals of migrants with serious criminal records while placing other categories lower on the list.

Garfield High students rally in Los Angeles in support of “dreamers,” young immigrants protected by DACA, in 2019. (Irfan Khan/Los Angeles Times)

It is under this authority that “dreamers” — or undocumented immigrants who came to the United States as children — have been allowed to remain in the country under the Obama-era Deferred Action for Childhood Arrivals program.

Temporary protected status has been used on groups facing natural disasters or conflicts in their home countries. That status has provided sanctuary to certain Haitians and Salvadorans starting in the 1990s.

“It allows them to stay here until the conditions are better,” said Tammy Lin, a San Diego immigration attorney.

But the status must constantly be renewed and could be scrapped by a new presidential administration.

Temporary protected status designations also traditionally apply to people already on U.S. soil, leaving some experts to question if it could be used on newly arriving — or more like re-arriving — families.

Another more far-fetched solution that has been floated is the possibility of granting the families U-visas, which are reserved for crime victims as long as they show they are cooperating with authorities on an investigation.

Using a U-visa in this circumstance would certainly be non-traditional — it would an acknowledgement that the government itself was the perpetrator of the crime, attorneys said. It is an unlikely avenue for another reason: U-visa applications are significantly backlogged, with waits averaging four to five years.

No matter what the solution, it will likely use some degree of creativity to address an unprecedented situation, attorneys said.

“If they want to make up something completely new, it needs to be pretty narrow and be able to sustain any lawsuits,” said Lin.

Up to Congress

The most permanent solution is legislation.

“Realistically, it’s the most obvious way to get these families some kind of permanent immigration relief,” McLean said. “The executive branch has limited power to grant permanent immigration status.”

A measure called the Families Belong Together Act was introduced in both the House and Senate at the beginning of 2019 by Sen. Richard Blumenthal, D-Conn., and Rep. Joaquin Castro, D-Texas.

It proposed permanent resident status to children and their parents or legal guardians who had been separated, whether they had remained in the U.S. or returned to their home countries.

But the measure did not get beyond committee referral.

The Cazun family of Guatemala after reuniting in 2018 at Cincinnati/Northern Kentucky International Airport following their separation after they crossed the Rio Grande into the United States. (ASSOCIATED PRESS)

A new version is currently in the works, said McLean. Whether such a measure would get enough bipartisan support is unclear, but immigrant advocates are hopeful. Many Republicans rebuked the separations and called for an end to the practice in June 2018 as the full force of the Trump administration’s actions gained publicity.

“Something about family separations touched a nerve with the public,” said Donohoe, managing attorney for Al Otro Lado’s Family Reunification Project, “and if there is one area we feel like we can agree on, that this was bad and we should do something for these people, then this it.”

Until then, families are placing their hope in the task force — and even that is shaky.

“The reunification is just the first step,” Donohoe said. “The feel-good picture of them hugging, while that is beautiful, there is a lot of healing that has to go on. A lot of trust has been broken, a lot of damage has been done.”

Al Otro Lado, with offices in San Diego and Los Angeles, is representing 36 parents in Central America. They are ready to go, Donohoe said.

That includes a mother who was separated from her son when he was 3. She is aching to be with him again.

“She’s lost three years of his life,” Donohoe said. “Every day they are separated is another day of torture.”

Hundreds of stem cell clinics offer unapproved, unregulated treatments in Arizona

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A device places liquid into test tubes under ultraviolet light. (Getty Images)

“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.

Older, wealthier communities targeted

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.

Questionable qualifications

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.

Copy text Copy this quote’s text The quote has been copied Tweet Facebook Email Email this story Share Share this story Emma Frow, ASU professor and researcher 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. Quote icon

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.

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.

‘Tapping into human suffering’

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. 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.

Copy text Copy this quote’s text The quote has been copied Tweet Facebook Email Email this story Share Share this story Salvatore LaCognata, orthopedic surgeon who performs stem cell procedures I have not done any studies and I don’t plan to do any studies. I don’t need a study to convince me. … What we have to do is use it responsibly. Quote icon

“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’s a lot of quackery’

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.