The headlines sound almost too good to be true: Researchers Stunned by Stem Cell Experiment That Helped Stroke Patient Walk; Wife Recovered From Cancer After Pioneering Stem Cell Treatment; Stem Cell Transplant Trial Has Miraculous Effect on Multiple Sclerosis Sufferers.
Indeed, even experts are excited about these miracle cells, which are abundant in the body and can repair and replace all kinds of tissue. Theres no doubt in my mind that stem cells are going to revolutionize the way medicine is practicedwith the same kind of impact that antibiotics and vaccinations hadgetting at the root causes of disease rather than dancing around the periphery, says Charles Murry, M.D., Ph.D., director of the Institute for Stem Cell and Regenerative Medicine at the University of Washington in Seattle.
But when it comes to medical research, Dr. Murry cautions, stem cells are barely at the starting gate. Despite their hitting the petri dish more than 20 years ago, many big questions remain: Which people, with which diseases, might benefit from their use? What types of stem cells should be used? How can the cells be manipulated and administered for lasting effect? And how does the treatment work? Exciting as the clinical trials are, most of those that have been completed so far are just at the phase one stage, in which researchers test a small number of people to see if an intervention is safe, not yet whether its effective.
What actually is too good to be true, then, are the claims being made by many of the for-profit stem cell clinics that have proliferated in the U.S. (more than 700 and counting). Using nothing more than very early study results and testimonials, these clinics promise thatfor thousands or tens of thousands of dollarsthey can use your own stem cells to treat everything from MS and rheumatoid arthritis to heart disease, diabetes, damaged joints, and cancer. Some offer cosmetic stem cell face-lifts or cellular breast and buttock jobs; others promise to boost athletic prowess.
Theres a striking gap between the claims these centers are making and the research thats been done for most of these diseases, says Leigh Turner, Ph.D., an associate professor in bioethics at the University of Minnesota who studies these clinics. People need to be very cautious about this treatment right now.
Most of the cells in our bodies are specific types of cellsheart, lung, muscle, nerve, blood, and more. But stem cells are undifferentiated, which means they have the potential to turn into more stem cells or other types of cells. Stem cells also can divide indefinitely and replace worn-out tissue, giving them the ability to become other cells and the potential to act as a ready repair system for the body.
What it's like to have stem cells injected into your face for younger-looking skin:
Stem cells generate so much buzz because they have the unique ability to turn into different types of cells. This means they have the potential to rebuild organs that are diseased, which in the medical field is known as regenerative medicine. Early on, scientists focused on stem cells taken from embryos because those cells naturally transform into the myriad ones that develop into the babys tissues and organs. But ethical issues and federal regulations related to these cells sent researchers scrambling to find alternatives.
Today, cutting-edge scientists are working to coax adult blood cells to become nascent cells akin to the embryonic kind by adding certain DNA molecules. These induced pluripotent stem cells, which have shown early promise, generally require months of careful manipulation in a lab and thus are mainly limited to top medical centers. Most of the for-profit clinics have settled on using cells taken from fully developed tissue, known as adult stem cells. By using cells from a persons own body, these clinics can complete a treatment in a day or a few weeks. Doctors typically liposuction a little fat or remove some bone marrow (which is an especially rich source of stem cells), put it through a few steps to remove other tissue, then inject the stem cells where they want them to proliferate. Someone whos coming in with arthritic hip pain, for example, might have cells removed from her belly and inserted into her hip.
Critics say the for-profit clinics that currently claim they can treat all manner of disease with adult stem cells are not being honest. Much more study is needed before any of these claims can be substantiated, says Kapil Bharti, Ph.D., a research scientist at the National Eye Institute of the National Institutes of Health who is at the leading edge of research on using pluripotent cells to treat macular degeneration. The problem with the cells is what we dont know. Those clinics inject the cells and hope they will secrete something beneficial, but every time they do the injections, theyre rolling the dice, he says.
The scientific consensus is that stem cells taken from fat or bone marrow are not as malleable as embryonic cells, meaning that rather than turn into completely different cells, they mostly create more of the same tissue. There is zero evidence, for example, that bone marrow tissue can make eye tissue, even though many of these clinics say it can. The cells dont integrate, so they die off, Bharti saysand the injections may cause significant damage in the process.
At the moment, stem cell treatments are medically recommended only for a small number of blood disorders. To treat leukemia, for example, patients typically have their bone marrow harvested before their bodies are blasted with high-dose chemotherapy. The stem cells from the marrow are then reinserted into the bloodstream to restore damaged cells there.
Early-stage research involving other conditions reveals why physicians are so excited about the methods future prospects. A very small industry-funded clinical trial in Australia found that in people who had the anterior cruciate ligament (ACL) in the knee reconstructed, those who subsequently had stem cells injected into their knees had less pain and better physical results on their MRIs than did a control group. An ongoing multiyear study of 110 patients with relapsing-remitting MS is finding that those treated with stem cells from their own bone marrow (along with some chemotherapy and/or radiation) are much less likely to have their disability worsen than those on standard disease-modifying drugsan incredible 6% versus 60%.
The potential to help her severe MS was what drove SammyJo Wilkinson of Edmonds, WA, to seek out stem cell treatment from a for-profit clinic in 2012. Wilkinson was desperate for something that might improve a disease that had forced her to shutter her thriving technology company and go on disability a decade earlier. After researching clinics, she settled on one in Texas (later relocated to Mexico). She liked that the clinic was up-front that the procedure was experimental and that her stem cells were banked for future rounds.
Six years and five treatments later, Wilkinson is happy with the results, even though major symptoms, including blindness in her right eye and the inability to walk without a wheelchair, remain. But of the 28 symptoms she said had decimated her life, 17 have disappeared, from fatigue and brain fog to numbness in her hands. My quality of life is so much better. No current medication can do what this treatment did, she says. Still, when other women with MS call her for advice, she lets them know that she is not curedand that the cost of her treatments ($90,000 plus travel expenses, none of it covered by insurance) was staggering.
While Wilkinson was lucky that she had positive results, this isnt true for many others. Thats one reason stem cell scientists are angry that the Food and Drug Administration hasnt come down harder on for-profit clinics. Between 2011 and 2017, the FDA issued some warning letters, and the Department of Justice filed for injunctions against only two clinics (one with multiple locations) this past May. In December 2018, the FDA issued yet another warning after 12 patients fell seriously ill after receiving stem cell injections. Litigation is ongoing, although the clinics can still see patients.
For-profit clinics point out that the FDA differentiates between drugs that need to go through the multiyear, multimillion-dollar approval process and those that use minimally manipulated substances taken from a persons own body, which dont. The clinics claim their treatments fall into the latter category, though critics say theyre manipulated much more heavily than the FDA intended for nondrug treatments. This has come to be a really important line, and many for-profit businesses claim theyre on the right side of it when realistically they arent, says Paul S. Knoepfler, Ph.D., a professor at the UC Davis School of Medicine who runs The Niche (ipscell.com), a blog that sheds light on the industry.
It might seem that theres no danger in receiving a treatment using your own cells, but that isnt the case. People have suffered very serious complications, Turner says. An article in Nature counts nine lawsuits in which people alleged that their treatmentsfor diabetes, lupus, lung disease, cosmetic surgery, and morecaused them harm. A report in the New England Journal of Medicine described three women with macular degeneration whose vision significantly worsened (two are now legally blind) when stem cells harvested from belly fat were injected into their eyes. Several stem cell clinic patients have died.
And those are just the people we know aboutside effects and serious complications dont have to be reported by the clinics, Turner says. Whats more, once-promising treatments have been shown to be potentially dangerous. Doctors were initially excited to think stem cells might repair diseased hearts, but a 2017 study on mice found that when the cells were injected, they turned inflammatory and worsened heart disease. (More research is being done.)
Another big issue is money. The fees Wilkinson paid are typical, and even cheaper therapies can feel like a rip-off. Although one injection of stem cells several years ago helped Olympic track and field hurdler LaVonne Idlette heal tendinitis in her knee, when she went back to treat a pulled hamstring muscle, another injection did nothing. At $1,200 a shot, it was ridiculously expensive, says the 32-year-old Miami resident, now an attorney.
If you want to look into stem cell treatment, experts say the best way is to ask your doctor whether any reputable medical centers are conducting clinical trials focused on your disease. You can find trials at the National Institutes of Healths website clinicaltrials.gov, but theres another caveat: Some clinics say theyre doing a patient-funded study, and theyll even list it on the government website, but when you look at the details, there are a lot of red flags, Turner says. One of those is being asked to pay thousands of dollars to participate (reputable studies typically ask only that you pay your own travel fees). Turner also doubts that data from these so-called trials are being tabulated; he and others say some clinics are simply trying to legitimize risky treatments.
Beyond entering a trial youre sure is being done properly, experts say that for now you should steer clear. Mayo Clinic has started a regenerative medicine consult service and tells patients this: The current standard of care for nearly all medical conditions is still the best. If you have arthritis in your knees, for example, physical therapy, medication, or even knee replacement surgery will give you much better odds than experimental stem cell treatments, says Shane Shapiro, M.D., program director at Mayo Center Regenerative Medicine Therapeutic Suites.
Of course, clinics point to success stories as reasons to try their stem cell therapies. Seven years ago, Amy Klein, a freelance writer in New York City, received a stem cell face-lift to get rid of a tired complexion and dark bags under her eyes. Stem cells were taken from her stomach fat and injected into her face. So many years later, my skin still looks really good. Not only are my bags gone, but the quality of my skin is back to the dewy tightness of my youth, she says.
But when small numbers of patients claim good results, scientists call it anecdotal medicine and stress that its not strong enough evidence to base treatment advice on. Before you can call something a success, you have to repeat your findings with a large number of patients over a long period of time, Dr. Shapiro says. Until those major studies are done and its proven that stem cells are safe and effective for the conditions for which theyre being advertised, patients are simply rolling the dice.
Despite warnings, some patients with serious degenerative diseases who have tried all the conventional treatments choose for-profit stem cell clinics. If someone thinks its better to take a low-percentage shot as opposed to waiting for a degenerative disease to progress, that may not be an entirely irrational way to view things, says Dr. Murry. The problem is, its nearly impossible for the average patient to evaluate whether an unproven treatment has evidence for safety or efficacy. This is why the clinics need regulatory oversight.
How to protect yourself if you do decide to proceed:
See what the evidence shows. The federal database pubmed.gov lists results of most published studies. If you read reputable journals to see what the evidence reveals, youll be less likely to fall prey to a clinics overselling. If theres zero research on the use of stem cells for your condition, be especially concerned.
Know that some treatments are riskier than others. Procedures that inject cells into vital organs, like the brain, nervous system, heart, or eyes, have the potential to do more serious damage if the treatment goes awry than those aiming to fix joints or appearance.
Choose a clinic with care. If they tell you a treatment theyre selling has no risks, thats a big red flag: Theyre either woefully lacking in knowledge or not being honest, and I would walk away, says Paul S. Knoepfler, Ph.D. Keep your doctor informed. Youll want to let your physician know youre planning to do this, then see him or her soon after your treatment, Dr. Murry advises.
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Stem Cell Injections: What Are They & Does Stem Cell Therapy Work
