Stem Cell Therapy: Hope for Arthritis or Just Hype?
Experts say this treatment might not be ready for prime time and advisecaution.
Could cells harvested from your own body repair damaged joint cartilage and give you a reprieve from arthritis pain and stiffness? That’s the promise claimed by advocates of so-called “stem cell therapy”—a technique touted by clinics across the country as a “miracle treatment” for arthritis and other degenerative diseases.
The claims are so enticing that people have been willing to pay thousands of dollars per injection for cellular therapies for knee osteoarthritis. Yet there’s scant evidence to back up most of the promises, or to prove patients are getting their money’s worth from these therapies.
Marketing Stem Cell Therapies
“There’s a tremendous amount of hype that has built up around the idea of stem cell therapies,” says Cleveland Clinic orthopaedic surgeon George Muschler, MD, who has been studying stem cell treatments for more than two decades. “Patients have been fed the idea that stem cells are magic, and if you just put them in the body someplace they’ll know what to do. But the proof isn’t there.”
Hundreds of stem cell clinics have popped up across the country, many of them hoping to cash in on the enthusiasm surrounding this treatment. “The field, particularly in the past five years, has been overrun with a large number of people who have co-opted the word ‘stem’ and have been using it as a marketing tool to offer therapies to patients that are as yet unproven,” says Dr. Muschler. “That practice is a misuse of the term ‘stem cell’ and amounts to selling false hope.”
Dr. Muschler and his colleagues recently investigated centers marketing stem cell therapies for musculoskeletal conditions like knee osteoarthritis. Presenting the case of a 57-year-old man with knee osteoarthritis, they contacted 273 U.S.-based centers and asked them about their pricing and efficacy. On average, the centers claimed 80 percent of their patients had good results or symptom improvement—results that are not yet supported by high-quality research.
“Most of the claims these clinics make are based on patient satisfaction, which is a very broad term,” says Nicolas Piuzzi, MD, a Cleveland Clinic research fellow and co-author of the study with Dr. Muschler. “We don’t know how the researchers ask and record satisfaction. Very few centers making these claims have actively tracked their results or published the data in peer-reviewed literature to support their claims.”
In a previous study published in The Journal of Bone and Joint Surgery (September 2016), Drs. Muschler and Piuzzi looked at the state of cellular therapy research. They found only six well-designed studies on cell-based therapies for knee osteoarthritis and cartilage damage. Though the studies did note some improvements in pain and function after the treatment, most had too few patients or insufficient controls to confirm the therapy works.
As unproven treatments, stem cell therapies come with a steep price tag. Dr. Piuzzi says the average price quoted by the centers that were contacted was over $5,000 per injection, which is not covered by insurance.
Promise of Stem Cells
The promise of using stem cells to treat disease lies in their versatility. Stem cells exist in our bodies. Some have the potential to divide and transform into many different cell types, including muscle, blood and cartilage. These cells are a necessary part of life and health, serving as the body’s built-in repair system, constantly regenerating and renewing tissues damaged by disease andinjury.
Most of the cells used in cellular therapy are removed from the patient’s own bone marrow or blood. Cells can also be harvested from fat removed via liposuction.
Current methods for cell collection provide a diverse mixture of the cells present in these tissues. The methods do very little to select true stem cells and eliminate cells that are not stem cells.
“True stem cells are the least common cell of all in these preparations,” says Dr. Muschler. “Only one out of every 20,000 cells in bone marrow can contribute to new tissue formation, and only a few percent of those are a true stem cell.” Most stem cell clinics do not measure how many cells they inject and do not measure the number of stem and progenitor cells that are present in what they inject into patients.
“The legitimate question is, can we harvest, process and transplant that critical but small and rare fraction of progenitor stem cells to enhance tissue formation?” says Dr. Muschler. “This is an exciting and important question. We will figure this out, but the truth is that we are not there yet, and patients need to be honestly informed.”
Still in its infancy, cellular therapy is a little like the Wild West. While some legitimate clinics do exist, shady purveyors also abound. Many push unproven treatments, and some push therapies that are unlikely to work and could be harmful.
“Cells that aren’t properly prepared could potentially cause an infection or immune system reaction,” says Dr. Muschler. There have been published reports of direct-to-consumer marketed stem cell treatments causing blindness, paralysis and evendeath.
Currently, there’s very little government oversight to protect consumers from paying for empty promises. The only FDA-approved stem cell therapies are for blood-forming (hematopoietic) stem cells used to treat people with certain blood disorders.
The FDA doesn’t regulate treatments in which human cell and tissue products, such as blood, are taken from a person, minimally manipulated and then reinjected into the same person. In 2017, responding to growing concerns about disreputable behavior in the industry, the FDA vowed to increase regulations and crack down on unscrupulous clinics.
If you’re considering a cell-based treatment for arthritis, Dr. Muschler suggests sticking with credible institutions. “In large institutions, such as Cleveland Clinic and other academic centers, there are systems of checks and balances that look over the doctors’ shoulder while they provide these therapies to ensure patent safety,” he says. “That’s different from freestanding clinics that provide only so-called stem celltherapy.”
High-quality facilities will evaluate your arthritis and joint function before and after the treatment to see if a given therapy has any effect on your disease. They will also measure and know the number and attributes of the cells that you are receiving.