For Americans suffering the aches and disability of aging and injury, chiropractors such as Trent Ryan say they have a cutting-edge solution: stem cells.
At a recent event billed as an "educational seminar" at the Chadds Ford Historical Society, Ryan told 25 people in their 60s to 90s that injections of their own bone-marrow stem cells could repair arthritic knees and creaky spines — without the pain and complications of conventional surgery, addictive painkillers, steroids, or physical therapy.
"This is like magic. It really is," said Ryan, a Wilmington chiropractor who is affiliated with a new company founded by chiropractors called Regen America: Centers for Regenerative Medicine.
"You can turn back the clock," Ryan asserted, showing knee scans that he said displayed cartilage regrowth. "Can you imagine this ability to regrow, rebuild, and regenerate what you need? This is real. I don't make this stuff up."
There's no way his listeners — most drawn by splashy ads in newspapers including the Inquirer — could verify the fantastic claims.
A vast stem-cell industry has exploded in the United States in recent years, promising to fix everything from autism to blindness. Orthopedic applications are the fastest-growing segment, according to a study published last year. None of these treatments has been proven safe or effective by rigorous studies, and none has been approved by the U.S. Food and Drug Administration, which is facing increasing pressure to crack down.
Ryan only vaguely explained how the procedures are done and, when asked, said insurance doesn't cover it. The price at his clinic, he said, is $4,500 for the first joint, $4,000 for the next one, and $12,500 for the spine.
Many in the audience signed up to be evaluated for treatment.
The commercial boom troubles but doesn't surprise Harvard Medical School dean George Daley, an internationally known stem-cell researcher.
"What we're seeing in this industry are practitioners who want to exploit an exciting period to market unproven interventions directly to patients, and that's helped by the internet," he said. "None of this is proven. It has only the veneer of scientific respectability."
Mainstream orthopedic researchers who are trying to go deeper and build a solid scientific basis for using stem cells say the hype that chiropractors rely on is disturbing and deceptive.
"We're at a place right now where stem cells are being used more and more in orthopedics, but it is not magic," said James P. Bradley, a sports medicine researcher who has been the Pittsburgh Steelers' orthopedic surgeon for decades.
He's particularly concerned that the marketing targets seniors, because they're the least likely to be helped.
"The older you get, the less stem cells you have," Bradley said. "If patients have bone-on-bone [knee] arthritis, telling them it's going to regrow their cartilage — that's a lie."
Brookhaven chiropractor Jason Weigner, who founded Regen America about a year ago with Philadelphia chiropractor William Pezzello, said there is no intent to mislead anyone.
"I can see why people would say that," said Weigner, whose 26 affiliates include physicians. "But there is no guarantee with any procedure with Regen America. The point is to help the public and educate the public."
Said Ryan, "I don't make statements that mislead people. I do get very passionate about it. It's amazing stuff and it's the wave of the future."
‘If it works, it’s worth it’
At 84, Milli Burke knows better than to expect miracles. But the Wilmington woman doesn't want to spend up to a year recovering from knee-replacement surgery, curbing her travel, gardening, and busy lifestyle.
So spending $9,000 to get her own stem cells sucked out of her pelvis and injected into her arthritic knees at Ryan's clinic sounded like a reasonable risk.
"It's a gamble," she said. "I realize that. If it works, it's worth it. If it doesn't work, I say: 'You're a stupid idiot.' "
Like most others at the Chadds Ford seminar, she saw a newspaper ad touting a "breakthrough in natural medicine." She didn't try to learn about stem cells by surfing the internet because she's not comfortable with computers. Nor did she initially inform her four children — not even the oldest, a dentist — of her gamble because she didn't want to be second-guessed.
"It's my choice," she said.
On Aug. 22, she went to Ryan's clinic in Wilmington, where they both allowed an Inquirer reporter to observe.
She stretched out on her stomach on an exam table. Physician assistant Richard Jaskewich draped sterile surgical fabric so only her lower back — already numbed with a local anesthetic — was exposed. He swabbed the area with an antiseptic solution, then inserted a hollow needlelike instrument to suck out, or aspirate, the marrow.
Researchers spin the marrow in a centrifuge to concentrate the stem cells because the knee doesn't have room for a big injection of fluid. They also use a special machine that counts the stem cells in the dose.
In contrast, Regen America uses an aspiration device, made by Ranfac Corp. of Avon, Mass., that is claimed to automatically increase the stem-cell concentration in a small sample without a centrifuge; the patient's actual cell count is not determined.
Burke's aspiration took less than 10 minutes. Then, under X-ray guidance, each knee was injected. She was issued bulky black knee braces — covered by Medicare — and told to take it easy.
"If it hurts, don't do it. Underdo it. No shopping. No long walks," Ryan told her.
During his seminar, he said that on a scale of 1 to 10, patients' pain goes from about 5 to 2 just a week after treatment, and by the fifth week, most are "out of pain."
A week after her treatment, Milli said her intermittent level 5 pain was slightly better, "but I can't say there's a ta-dah."
A month after treatment, she was not wearing the braces — they kept sliding down — but sat with her legs elevated at least two hours a day, something she didn't do before the procedure. Climbing stairs didn't hurt as much as before. She canceled the scheduled knee-replacement surgery.
By the eighth week, she said her pain was occasional and down to a 2 — too much improvement to be just placebo effect.
"I really do feel better," she said.
‘No credible data’
A decade ago, Americans who wanted experimental cell treatments had to travel overseas. Desperate "stem-cell tourists," seeking cures for incurable conditions such as Parkinson's or paralysis, spent staggering sums in hopes that clinics in developing countries had realized the dream of regenerative medicine.
Meanwhile, U.S. researchers in various specialties were reporting progress in using the body's own growth factors and proteins to aid healing. Regenerative therapies included platelets from the patient's own blood, amniotic membrane donated by women after cesarean-section births, as well as stem cells taken from the patients' bone marrow, fat, or other tissues.
Orthopedic use of stem cells began about a decade ago. One of the pioneers, Colorado physician Christopher Centeno, who is board certified in physical medicine, rehabilitation, and pain management, founded Regenexx in 2011 as a national physician network offering his stem-cell procedures to treat musculoskeletal problems. One of his group's research findings is that the optimal total stem-cell count for an arthritic knee is at least 400 million — and while most patients over 60 have enough to treat one knee, most don't have enough for both knees.
On his blog, Centeno has written blistering critiques of chiropractor-run stem-cell enterprises, particularly Stem Cell Institute of America, a Canton, Ga.-based firm that shows hundreds of "partner locations" on its online map.
The firm claims that its amniotic tissue-based treatment contains "regenerative cells," but companies that process the donated amniotic tissue dehydrate and irradiate it, which destroys cells. Centeno's lab verified the absence of cells.
"The amniotic fluid they're selling as a miracle stem-cell cure for arthritis … has no credible data showing it contains viable cells or that it can regrow a new knee," Centeno wrote on his blog.
Chiropractor Brent J. Detelich, who incorporated Stem Cell Institute of America in 2015, did not respond to repeated requests for comment.
The FDA position
The only stem-cell therapies that the FDA has approved use cells from bone marrow or umbilical cord blood to treat blood cancers and certain immune disorders. In general, biologic tissues that are processed and marketed as therapies are supposed to go through the FDA's drug-approval process, which requires years of costly testing in humans to show safety and effectiveness.
Recognizing the promise of stem cells, the FDA has issued draft guidance that exempts stem-cell treatments from the drug-approval process under certain scenarios. Among other criteria, the cells must be used in a "homologous" way, meaning for the same function they perform naturally in the body, and be "minimally manipulated."
Although there have not been many reports of serious injuries from unapproved stem-cell treatments, some shocking examples have made headlines — and waves. In August, the FDA announced a clampdown on deceptive and dangerous stem-cell clinics, starting with actions against a Florida company that ruined the eyesight of three women, and a California company accused of giving smallpox vaccine to cancer patients.
This month, California adopted a first-of-its-kind law requiring clinics to post a notice and give each patient a handout disclosing that their stem-cell therapies are not approved by the FDA.
‘I don’t know what to think’
Consumers are left to try to make sense of conflicting, confusing information.
Pat Baxter, 67, of Broomall, a retired occupational therapist, went to Ryan's seminar in Chadds Ford because she has arthritic knees.
"I don't know what to think of his presentation. It seemed rather grandiose," said Baxter, who left unconvinced. "I'd like to know more about the possible side effects and complications."
Complications from extracting and injecting marrow stem cells are uncommon, but potentially serious. The risks include infection, nerve injury, paralysis, perforation of the pelvic bone, allergic reaction, lung blood clots, delayed wound healing, and even death, according to Regen America's informed-consent form for patients.
The benefit side is unclear. Numerous studies have found circumstantial evidence of some effectiveness in orthopedics, such as positive changes on medical imaging, or patients' reports of less pain and better functioning. Patients' testimonials are a staple of the websites of stem-cell practitioners — physicians as well as chiropractors.
But without a comparison group that didn't get the therapy, it's impossible to be sure the improvements were due to stem cells. Rigorous studies with comparison groups, called randomized clinical trials, are still needed to figure out the role of regenerative approaches, especially with older patients, experts say.
"The bottom line is, we do not have this all figured out yet," said Glen Mills physician Brian Shiple, who was chief of sports medicine at Crozer-Keystone Health System before setting up an orthopedic practice specializing in stem-cell and regenerative therapies.
Centeno, the Colorado physician, believes that over the next 20 years, new biologic therapies such as stem cells will transform how orthopedic care is delivered, making it far less reliant on surgery.
But there is a caveat.
"There are patients that respond and patients that fail these therapies," he said. "This is not a panacea, not a miracle."