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Unproven stem cell products are being peddled as COVID-19 ‘therapies,’ U of M researcher reports

U of M ethicist Leigh Leigh describes the latest twist in a cynical saga: how some stem cell businesses are “seizing the  pandemic as an opportunity to profit from hope and desperation.”

Mesenchymal stem cell
Human bone marrow-derived Mesenchymal stem cell showing fibroblast-like morphology seen under phase contrast microscope at 63 x magnification.

Coronavirus health scams are rampant, with businesses taking advantage of people’s fears to sell all sorts of unproven products for the prevention and treatment of COVID-19. Some of these snake oil cures are innocuous, such as elderberry juice, but others can be harmful, such as colloidal silver.

Among the products with considerable potential for harm are unproven stem cell “therapies.” Unfortunately, the emergence of this particular line of sham COVID-19 treatments isn’t all that surprising. For more than a decade, businesses have been aggressively pitching unsubstantiated — and unlicensed — stem cell products to vulnerable and often desperate individuals with illnesses or injuries for which no known treatment exists, such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD) and spinal cord injuries. The results have sometimes been deadly.

There are some medical conditions for which stem cell therapies have been shown to be safe and effective, but they are few in number — mostly cancer and several blood and immune disorders.

Leigh Turner, a bioethicist at the University of Minnesota, has been investigating the direct-to-consumer marketing of spurious stem cell “therapies” and related exosome products in the United States for nearly a decade. In an article published recently in the journal Cell Stem Cell, Leigh describes the latest twist in this cynical saga: how some stem cell businesses are “seizing the [COVID-19] pandemic as an opportunity to profit from hope and desperation.”

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MinnPost spoke with Turner late last week about what he found when researching that paper. The following is an edited transcript of the interview.

MinnPost: Companies seem to be using the same kind of marketing strategies to sell unproven stem cell therapies for COVID-19 as they have for other medical conditions.

Leigh Turner: Yes. These are opportunistic businesses. They look for marketplace opportunities, ways to generate e-revenue streams. And the COVID-19 pandemic is another business opportunity. It’s not like they’ve pivoted away from what they did in the past. If they were marketing stem cell treatments for Parkinson’s disease, or ALS or spinal injuries, they haven’t stopped doing that. They’ve just added that they’ve now got a stem cell treatment or an exosome therapy to treat or prevent COVID-19.

MP: They seem to be marketing their products primary as immune system boosters.

Leigh Turner
Leigh Turner
LT: Yes. That’s the core marketing pitch — that these stem cell therapies are preventive treatments that will boost the immune system. They’re not targeting people in hospital ICUs with COVID-19 who are in dire straits with acute respiratory distress syndrome.  They’re targeting the “worried well” — people who are anxious and fearful of the pandemic, which is a pretty large part of the population. These are people who are well enough to come to the clinic or to order something online.

MP: At least one company is telling people that they should bank their stem cells to use as a treament if they get infected with the coronavirus.

LT: There are several business models at play right now. One is, come on in and get your stem cell immune booster to reduce your chances of getting COVID-19. They may also claim it will reduce your symptoms should you get it. Another marketing pitch is a bit more cautious. It says that if you come in now when you’re in good health, they will bank your cells. You’ll pay for the initial extraction of cells and also monthly or yearly for banking. The company then claims that should you fall ill with COVID-19 down the road, you’ll have those healthy cells available for you to use. Of course, they don’t offer a lot of detail about how the cells would actually help you. You just supposed to take it for granted that they will.

MP: There’s no evidence of that.

LT: No. It’s all just pseudoscience. But there is a meaningful hypothesis behind it. That’s how these businesses operate — by fusing science with pseudoscience, credible research with junk claims.

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MP: What is that hypothesis?

LT: There are companies and academic institutions right now that are interested in testing stem cell products, but not as immune boosters, not to prevent COVID-19 and not to eliminate the virus if someone gets infected. The studies right now are focusing on a very particular population of people with COVID-19 — those who are typically in ICUs, suffering from acute respiratory distress syndrome. The hypothesis is that if certain types of stem cell products are administered to those people, we may be able to reduce inflammation in the lungs and help shorten the illness. But it’s a hypothesis.

MP:  A good one?

LT: It’s not an outrageous hypothesis. If you look at the existing literature, there have been studies done in the past that used stem cells for lung and respiratory disease. So far, those studies suggest that if you use clinical-grade stem cells — and if you do it in a very rigorous way — the safety profile is pretty good. But none of those studies has established extensive evidence of efficacy yet. Ideally, what you want is carefully designed, carefully conducted clinical trials testing that hypothesis and generating that evidence. These businesses  — the ones marketing stem cell therapies directly to individuals — are not part of that scientific world.

MP: How do those businesses pull their customers in? How do they find them? 

LT: They are typically big on social media. I’m talking generally here, but they have Twitter accounts. They have YouTube channels.  They have a Facebook page. They’re not just putting up a website and hoping that somebody walks in the door. They hire social media marketing companies. They use marketing firms. They have pretty sophisticated marketing strategies that are tailored to particular demographics. It may be that they are targeting an elderly population, for example, because if you’re interested in reaching people with COPD, you’re not going to be trying to find 18-year-olds. Some businesses here in Minneapolis and elsewhere will have what they describe as educational seminars, which are basically infomercials. They are marketing events. They will try to get people to come to a convention center, a hotel [conference] room or a restaurant. Everything is free, but what they’ll do is use hard-sell sales tactics to get people to commit, to write a check. Often they’ll tell people that if they sign on today, they’ll knock $2,000 or so off the price. But, of course, they’re not holding these events right now. They can’t have these public gatherings.

MP: So, how are they selling people these products now, during the pandemic?

LT: More of it is happening online. One company, for example, uses a graduated pricing model. If it’s one person, it’s one price point. If it’s you and a family member, you both get a break on the procedure. And if it’s you and two additional family members, the price goes down even more. They use these things to try to get people to come in the door. One company in California has adapted to the pandemic in a different way. They have a do-it-yourself model. You don’t have to even come into the clinic. You can buy their kit, and they ship it to your home. You then do the procedure at your dining room table.

MP: These stem cell products and treatments are quite expensive.

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LT: Yes, some of the businesses I’ve look at charge tens of thousands of dollars, although that’s not necessarily for treating COVID-19. For COVID-19, it appears to be in the thousands-of-dollars category. In some cases, we don’t know. The businesses can be pretty cagey. In some cases, they try to size up the customer and figure out how much they can extract from that person.

MP: Government agencies are cracking down on some of these stem cell businesses.

LT: The FDA (Food and Drug Administration), FTC (Federal Trade Commission) and Department of Justice have said that they’re going to be aggressive with dealing with these scams. And they have. Some businesses have already received letters from the regulators. That may be having a deterrent effect during the pandemic. Some businesses may want to jump in, but are afraid to do so. They may be waiting to see what happens before they take the chance.

MP: But the regulatory agencies are obviously not finding all of the businesses marketing unproven COVID-19 therapies.

LT: There is a lot of marketing fraud. And sometimes it’s quite challenging to figure out what’s going on. Some of the clinics that I looked at didn’t say, “We’re offering an immune booster for COVID-19.” It was more just chatter. Clinics would put up a seven-minute video from one of their doctors about COVID-19 and emerging stem-cell research coming out of China, saying it was really encouraging. Then they would say, “If you have any questions about stem cells and COVID-19, give us a call.” So, what’s the takeaway when a business does that? Does that mean they are selling stem cell treatments for COVID-19? Or are they just trying to get people to call? It’s hard to know what’s happening. If I had to guess, I say it’s a workaround. The businesses don’t want to put it on their website, because that’s too easy for someone from the FTC or the FDA to find. If they just put up a video, they can say they’re not marketing anything, that it was just meant to be educational.

MP: These businesses seem to rely on anecdotal cases or really small studies from China to support their claims.

LT: They use China in a couple of different ways. There was a case report, for example, that was published as a preprint. It wasn’t published by a journal. It hasn’t gone through peer review. It was just a preprint that someone put online. It’s the case of a single individual with COVID-19 who received stem cells. That’s been written up in a very hyperbolic way, when really, it’s just a case report. It’s one person. Some people get COVID-19 and recover anyway. You can’t draw any conclusions from it about stem cells being efficacious, but it’s been written up that way.  There was another study, very preliminary research, in which mesenchymal stem cells were administered to seven individuals with COVID-19 with various degrees of severity. A placebo was given to three individuals. The article doesn’t provide the source of the stem cells. Nor does it provide much insight about the individuals who were given placebos, although they appear to be about 10 years older than [those receiving the stem cells]. It raises some interesting questions. It provides a basis for further research. But, unfortunately, some of the news media reports have been hyperbolic. Stem cell businesses use both these papers when marketing directly to consumers. They refer to these studies, and they also attach themselves to the bubbly media coverage.

MP: Consumers need to know that these products can be dangerous.

LT: Yes. The danger comes in several forms. Part of it is that these are financial scams — lifting money off people who are worried and anxious. But, also, giving someone a product that hasn’t been carefully tested in well-designed clinical trials raises a lot of concerns. Some businesses have released contaminated stem cell products into the marketplace. People end up getting infections and having to be hospitalized. It can be a very serious thing. There’s also the possibility that the wrong type of cell goes to the wrong part of the body and causes harm. When a company claims, for example, that a stem cell product will regenerate lung tissue and be an immune booster, one thing I would worry about is pulmonary embolisms. If someone is being given something that hasn’t been thoroughly tested, it’s hard to know what would go wrong, but it’s easy to know something could go wrong.

FMI: You’ll find the article on Cell Stem Cell’s website.