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?
“There are a huge number of clinical trials, but there has been next to no published information” about the use of stem cell injections to treat problems like Griffiths’, says scientist Pamela Robey, a Bethesda resident who serves as co-coordinator of the National Institutes of Health’s Bone Marrow Stromal Cell Transplantation Center. “The bottom line is there’s no real rigorous data showing it is actually repairing the joint.”
Friedlis answers questions about stem cell injection therapy during a January seminar for prospective patients.
Generally, scientists consider “rigorous data” to be information collected in randomized controlled trials—the gold standard of medical research. To test bone marrow stem cell injections, patients in this type of study would be randomly assigned to receive either shots of their own cells or of a placebo, an inactive substance such as saltwater. The patients and researchers usually don’t know who is in which group until the end of the study. This minimizes the chance that any benefits seen in the treatment group are connected to something other than the therapy itself, namely some characteristic of the patients or to the placebo effect, which can have a powerful impact on pain.
“The rigorous data that’s out there shows that the cells disappear very rapidly. They don’t really become a part of the tissue, don’t really repair damaged tissue,” Robey says. While the stem cell injections appear to be safe, she says, “We don’t know how many adverse events have happened that have not been reported.”
Doctors who inject patients’ joints with cells extracted from their bone marrow “are telling people who need help that they can help them, but what they have to offer them is, in general, unproven,” says scientist Larry Goldstein, director of the University of California, San Diego Stem Cell Program. “It’s telling a fairytale to make people happy.”
Goldstein serves on the Ethics and Public Policy Committee of the International Society for Stem Cell Research (ISSCR), a nonprofit based in suburban Chicago. ISSCR has created a website, www.closer lookatstemcells.org, that’s aimed at consumers. Among the website’s “Top 10 Things to Know About Stem Cell Treatments” is this: “Currently, there are very few widely accepted stem cell therapies.”
About five months after being injected with his own stem cells in July, Griffiths says he’s happy with the results. He has spent about $6,000 on treatments from Friedlis, which included a shot in early November of “platelet-rich plasma,” or PRP, promoted by Friedlis and other physicians who offer it as a way to speed the healing of injured tissues and used by professional athletes, including Tiger Woods. While the risks of PRP are minimal, according to the American Academy of Orthopaedic Surgeons, research studies to back up its effectiveness are lacking.
The range of motion in his hip is a little bit better, Griffiths says. “The pain’s improved, and I’m on less medicine.” He’s not limping anymore. “Is my joint ever going to go back to normal? Probably not. I’ve come to accept that.” He’s still a jock, but instead of playing basketball, he swims and bikes and plans to take up yoga, all activities that are easier on the hips.
Griffiths’ doctor has also been on the other side of the needle. Friedlis, who earned his medical degree from Wayne State University in Detroit, received stem cell treatments last summer at Regenexx headquarters for a rotator cuff injury.
“I believe in it,” he says. “I’m a very active person. I would not be without Regenexx treatments.” An avid climber—he says he has trekked the Himalayas in India and climbed to a base camp on Mount Everest—Friedlis says he still needs surgery for the removal of a bone spur in his shoulder.
He agrees that many questions remain about the stem cell injections. “It’s not proven,” he says. “It’s totally experimental. The state of the science right now is weak.” Friedlis says he makes that clear to prospective patients, telling them, “You may respond great, or you may not respond at all.” The majority do feel better by three months after treatment, he says.
Most of the published research, mainly case studies or “outcomes studies,” in which researchers report how patients are faring months or years after receiving stem cell injections, has appeared in specialty scientific journals that don’t have the impact of, say, The New England Journal of Medicine. One study, led by a researcher at Stanford University Medical Center, found that PRP injections led to “meaningful improvements” for people with tennis elbow.
“There’s been a lot of skepticism in major journals that have not wanted to publish this data,” says Dr. Victor Ibrahim, a physiatrist who treats patients with injections of their own stem cells at offices in Silver Spring and Rockville. “Mainstream publications don’t want to be perceived as too ideological or cutting edge.”
Born in Cairo, Egypt, Ibrahim, 35, spent his high school summers working in the lab of a Case Western Reserve University neuroscientist who was trying to regrow spinal cords in rats. “That’s where my interest in stem cells started,” he says. It wasn’t until he completed medical school at Case Western that he began focusing on the use of stem cells to treat orthopedic problems. Ibrahim, who is not affiliated with Regenexx, says his patients now include players from the Washington Redskins and D.C. United.
While Goldstein argues that it is unethical to provide treatment that is not supported by rigorous randomized trials, Friedlis believes it would be unethical not to. “We have tons and tons of people coming through our doors who are getting improvements in their quality of life,” he says.
Patients shouldn’t have to wait “until the scientists at Mayo Clinic and UCLA and blah, blah, blah actually prove that it works. In a perfect world, everybody likes to see more evidence. But we are where we are right now.”
Ibrahim says he has referred only about 5 percent of his patients to joint replacement surgery because their condition was too advanced for treatment with stem cell injections. “Our goal is joint preservation,” he says. “Our ultimate goal is functional improvement.”
Ina Blumberg, a patient of Ibrahim’s, uses words such as “saint” and “miracle worker” to describe him. Blumberg, a Potomac resident who will turn 80 in May, is more active than many people decades younger. A speech pathologist, she worked for Montgomery County Public Schools until her retirement last July. While her husband, who’s also pushing 80, continues to work full time as an architect at the National Institutes of Health, Blumberg says she retired so she could spend more time at the couple’s second home in Jackson, Wyoming.