Too Good To Be True?

Too Good To Be True?

Some doctors are touting the benefits of using patients' own stem cells to heal injuries and relieve pain. But is the science there to back it up?

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Dr. Kevin Griffiths had just celebrated his 38th birthday in the fall of 2013 when an orthopedist told him he’d probably need hip replacement surgery by the time he turned 40.

Griffiths, a kidney specialist who lives in Rockville, has always been a jock, and by his mid-30s he had developed severe osteoarthritis in his right hip from years of playing football and basketball. He limped and was in constant pain.

But he balked at the prospect of exchanging the hip he’d been born with for an artificial joint. He didn’t want to go on short-term disability while recovering from hip replacement surgery. Plus, he says, he didn’t want to face the prospect of needing the same operation two or three more times down the road when the artificial joint wore out.

Periodic steroid injections temporarily reduced the inflammation in Griffiths’ hip and relieved the pain, but he knew that repeated injections could lead to adverse side effects such as weakened bones and muscles. “Being a physician, you don’t let someone inject you with steroids continually,” Griffiths says. And he didn’t want to take narcotic painkillers, which carry their own set of baggage.

A pain specialist suggested an alternative treatment: injections of Griffiths’ own stem cells into his bad hip. That physician referred him to Dr. Mayo Friedlis, who had just started seeing patients a few days a week in Chevy Chase.

Although scientific evidence supporting the use of stem cell injections was scant, Griffiths says, he concluded that the treatment was a viable option after discussing it with colleagues. Perhaps the treatment would at least tide him over until researchers developed better alternatives to hip replacement surgery.

“Medicine’s always evolving,” Griffiths says. “That was my thing—to buy more time if possible.”

Depending on your point of view, a nondescript white building on Friendship Boulevard in Chevy Chase, just up the street from Whole Foods Market and Bloomingdale’s, houses a doctor’s office that serves up cutting-edge, life-changing medical therapy—or a treatment that’s too good to be true.

One evening this past fall, a couple dozen people—prospective patients, family members and friends—gathered in Friedlis’ first-floor suite to nibble on crudités, sip bottled water and listen to him describe how he can help restore function to deteriorating joints and ease pain without surgery. Perhaps they’d learned about Friedlis because ads for his monthly “educational seminars” kept popping up in their Facebook news feeds.

More than 1 million knee and hip replacement operations are performed in the U.S. each year, making them two of the most common types of inpatient procedures, according to the Centers for Disease Control and Prevention. And it’s a sure bet that many other Americans would do anything to avoid surgery to replace their arthritic knees or hips with an artificial joint. Friedlis’ seminar attracted a sampling of them.

The trim 61-year-old Potomac resident is associated with one of about 25 independent medical practices in the “Regenexx Network,” created in 2012 by Regenexx, a suburban Denver company, to make its treatments available around the country. Friedlis, a physiatrist—a doctor who specializes in treating diseases and injuries of the nerves, muscles and bones that can affect mobility—says he has been administering stem cell injections for more than five years at his offices in Reston and Fairfax, Virginia, where he has two associates who are also Regenexx-trained physicians. They are the only ones in the Washington, D.C., area, although a few local doctors who aren’t affiliated with Regenexx also offer stem cell injections to treat musculoskeletal problems.

The night of the educational seminar, Friedlis wore a button-down shirt embroidered with National Spine and Pain Centers,” the 40-year-old pain management practice that owns StemCell Arts and where he serves as medical director. He used slides and a video to explain how he culls stem cells from bone marrow extracted from patients’ hips and then injects them into the site of their pain—typically shoulders, elbows, knees and hips.

He numbs the back of the hip and then inserts a needle to remove a small amount of bone marrow. Some blood is also taken from the patient’s arm. Stem cells are isolated from the samples and processed, and then, within a few hours, injected into the patient’s problem area along with what Friedlis says are growth factors found in blood platelets.

“It’s out of you, into you, with minimal processing,” Friedlis told his audience. No one seemed to blink when he noted that the treatment, which can cost as much as $7,500, was not covered by insurance.

“Everybody wants to know if it’s safe,” he told the crowd, which included people who appeared to be in their 30s up to one man who mentioned that he was 85. “It’s about as safe as a cortisone injection in your doctor’s office. We’re not growing eyeballs out of knees.”

The problem, some scientists say, is that research supporting the safety and effectiveness of stem cell injections is lacking, even though many patients swear by the procedure.

Adult stem cells—not to be confused with embryonic stem cells—are thought to maintain and repair the various tissues in which they reside. Bone marrow contains two types of stem cells, first identified more than 50 years ago. One type, called hematopoietic cells, can generate blood cells, while the other, called stromal cells, can generate bone, cartilage and fat.

Only a small number of stem cells exist in bone marrow and other tissues, and once they are removed from the body, they have a limited capacity to divide. While regenerating bone is one potential use of adult stem cells, scientists haven’t figured out how to sift them out of the bone marrow and grow them in the large quantities that would be needed to treat people. Regenexx says it has developed a way to culture, or grow, patients’ stem cells in a lab, but the company stopped doing that in 2010 after being sued by the Food and Drug Administration (FDA).

The FDA considers cultured stem cells to be a drug whose safety and effectiveness must be demonstrated in well-designed patient studies.

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