It’s been 18 years since Bernie Zeledon injured his knee while playing soccer with his kids. His doctor recommended surgery, but Zeledon didn’t want to risk infection or face a long recovery. So, he put up with the pain, took ibuprofen several times a week, and walked around “like a little old man.”
But in July, Zeledon, now 60, read about a new clinic in Charlotte, iOrthoBiologix. It offers non-surgical therapies for joint pain, including injections of platelet-rich plasma, derived from a person’s own blood to promote healing of tendon and muscle injuries and arthritis.
Zeledon knew the treatment was popular with professional athletes, such as Tiger Woods, Kobe Bryant and Peyton Manning. So, he called for a free consultation.
Two days later, Dr. Jason Tucker treated both his knees on the same day. And two weeks later, the swelling around Zeledon’s knees was down, he walked steadily with braces, and felt no pain.
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Platelet-rich plasma therapy, known as PRP, first gained widespread attention in 2009 when players for the Pittsburgh Steelers – Hines Ward with a sprained knee ligament and Troy Polamalu with a strained calf – had the injections, recovered quickly and went on to play in the Super Bowl.
That news led to demand from weekend warriors. And sports medicine doctors obliged, even though research to support the therapy was still thin.
In Charlotte, a few orthopedic practitioners, who offered PRP even before that Steelers moment, have been low-key about it, careful not to over-promise on results. But in the past year and a half, PRP – and a newer injection therapy using stem cells – have taken on a higher profile in Charlotte.
New providers are marketing “regenerative” or “bio-restorative” medicine as an alternative to joint replacement surgery.
▪ Flexogenix opened a SouthPark clinic, one of three clinics in North Carolina, in August 2015. Its full-page ad in the Observer says “regenerative therapy can stimulate new cell growth, regenerate new cartilage and accelerate the body’s natural process to rebuild tissue and heal itself.”
▪ iOrthoBiologix, which opened this summer in Ballantyne, was featured in a recent Men’s Health magazine about the benefits of stem cell therapy: “The idea is that you’re giving your own body more healing potential by using your own restorative stem cells and growth factors.”
▪ Atlas Integrated Healthcare, a chiropractic clinic in Matthews, touts owner Michael Schmitt’s “miraculous recovery” from knee pain after stem cell injections. Its full-page ad says the procedure “can literally repair and regenerate tissue in the body that has been damaged by age, disease or degeneration.”
As hopeful as this sounds, these therapies remain controversial in the medical community. They are also expensive – maybe several thousand dollars per injection – and insurance does not cover them.
Dr. Pat Connor, an OrthoCarolina surgeon and team physician for the Carolina Panthers, the Charlotte Knights and Joe Gibbs Racing, offers PRP to some patients. But he warns, “It’s important to balance hope versus hype.”
Research in the United States and Europe has produced contradictory results. Some show symptom improvement; others show the treatment is no better than placebo. Even doctors who believe PRP and stem cell injections relieve pain disagree whether it can regenerate tissue.
“The marketing gets ahead of the science,” said Dr. Scott Rodeo, an orthopedic surgeon at the Hospital for Special Surgery in New York City. “There is great potential there. But we need more data.…I’ve seen a number of disappointed patients who’ve spent a lot of money.…It may help, and it may not help.”
Dr. Sean Whalen, a Flexogenix cofounder who used to work in Gastonia, said there is “plenty of research that supports the effectiveness of PRP alone or in combination” with other therapies. Much of the skepticism comes from “old guard” orthopedic surgeons, he said, who are threatened by change that would reduce demand for surgery.
“Go back to (the introduction of) laparoscopic surgery,” Whalen said. “It was called the ‘snake oil of surgery’ at the time. Now, of course, it’s widely accepted, and it’s even the standard of care.”
Tucker, the founder of iOrthoBiologix, also disputes the doubters. He’s seen positive responses in patients, and cites a long list of studies, including his own, to support the benefits of PRP and stem cell injections.
“People that say there is no evidence for this,” Tucker said, “are categorically wrong.”
Alternative to surgery
Tucker’s interest in PRP stems from a high school football injury that led to three shoulder surgeries and derailed his dream of playing quarterback at Michigan State. Instead of an NFL career, he set his sights on becoming an orthopedic surgeon.
In 2010, he learned about the emerging field of “bio-restorative medicine,” which offered a less invasive, more natural alternative to surgery. Tucker switched his specialty to focus on PRP and, more recently, stem cell injection therapy.
In his new Ballantyne offices, Tucker proudly shows off his lab and its central feature, the centrifuge. He draws blood or bone marrow from a patient, spins it down in the centrifuge to produce stem cells or platelet-rich plasma, full of growth factors and anti-inflammatory substances, and then injects the concentrated substance into the patient’s joint and surrounding tissues.
With the centrifuge, he said, “We take out the bad and keep in the good.”
Tucker said he never offers a guarantee of improvement. And even if the therapy doesn’t work, he said, the option of knee replacement surgery is still available. “You haven’t burned any bridges,” he said.
At Flexogenix, Whalen said doctors offer an array of non-surgical alternatives, including traditional injections of cortisone or hyaluronic acid as well as the “more exotic” PRP and stem cell injections.
Whalen said he doesn’t advise using PRP alone for osteoarthritis, commonly known as “wear-and-tear arthritis.” But he said PRP could be used in conjunction with hyaluronic acid, a substance that occurs naturally in the body and helps lubricate the joint.
Combining PRP with stem cell injections is also beneficial for tendonopathy, such as tennis elbow, or partial tears of tendons, ligaments and cartilage, Whalen said. In this scenario, he likened stem cells to “grass seed” that won’t grow in the wrong environment. Adding PRP, he said, is like “adding fertilizer, sunlight and water” to help the grass grow.
Elsewhere in Charlotte, OrthoCarolina, one of the nation’s largest orthopedic groups, offers PRP injections as an option for patients with joint pain – but without the marketing push of the newer clinics in the city.
“I have had anecdotal success with it, but I’ve also had anecdotal failure,” said Connor, the Panthers team doctor. “I use it sparingly.…We don’t think it would hurt.”
Connor said many small studies have been done on PRP for various injuries, and results are contradictory. For example, he said, one study of patients with hamstring injuries found PRP was better than physical therapy alone. Another found “absolutely no difference.”
Earlier this year, researchers in the United Kingdom reviewed previous studies of patients with tennis elbow, a layman’s term for elbow pain caused by overuse of muscles. Connor said it showed “PRP had slightly better results than steroid injections, but was no better than placebo.”
PRP therapy is difficult to study, Connor said, because of so many variables, such as the location of the injury in the joint or muscle, whether the injury is acute or chronic and the quality of processing the blood and bone marrow.
On the plus side, he said, PRP is safe, and “intuitively it makes a lot of sense” to use healing factors from a person’s own blood. Connor said he offers it to patients as an option, but makes sure they understand it’s in “the investigational phase of its evolution.”
‘Need further data’
Rodeo, the New York surgeon, praises the potential for PRP and uses it “on occasion,” but said he’s careful about claims of success because research data is mixed.
Contrary to some claims, he said PRP injections don’t “regenerate cartilage and cure things.” He said there is little research about stem cell injections and “very little data that combining stem cells with PRP is more effective than one or the other.”
Dr. Brian Halpern, a family and sports medicine physician at the Hospital for Special Surgery, said he’s withholding judgment on stem cell injections until there is more data. But he’s enthusiastic about PRP. He cited several studies showing PRP alone is helpful for osteoarthritis pain.
Halpern said he got interested in PRP years ago, after becoming concerned about the long-term effects of cortisone injections. He read about veterinarians using PRP in horses and thought it made “physiologic sense.”
He offered it to several patients, explaining clearly that “I don’t know if this is going work.” The first five patients were “completely cured,” he said. “That convinced me that there was something to this.
“The beautiful part about this,” Halpern said, “is that your patient is healing themselves. You’re using their cells to heal them. You’re not putting a drug in there.”
‘It feels good’
At iOrthoBiologix in Charlotte, Zeledon returned to see Tucker two weeks after his knee injections.
His joints were no longer swollen. And he no longer complained of discomfort. That met Tucker’s primary goal – “relieving pain and improving function.…With that, we frequently get tissue regeneration.”
Zeledon had come to Tucker with several problems that caused his chronic pain – advanced osteoarthritis, a loose ACL and a torn meniscus. Instead of choosing between PRP and stem cell injections, Tucker did both, hoping for better results.
For two days, Zeledon wasn’t allowed to put weight on his joints. Gradually, he could do more, using first crutches and then braces. Like most patients, he was back to full activity in six weeks.
For the injections and two braces, Zeledon paid $6,400. None of it was covered by insurance. But he said: “It was just exactly what I was looking for.”
Three months after treatment, he’s back at work in his construction business. “I have no pain,” Zeledon said. “I coached my son’s soccer game (recently). I haven’t done that in years. I ran up and down the field. It feels good.”