The Ohio State University Wexner Medical Center is conducting the first-ever prospective, randomized clinical trial comparing injection of a patient’s own fat-derived stem cells versus platelet-rich plasma (PRP) treatments for people with moderate knee osteoarthritis.
“Stem cell therapies hold immense promise. They’re the next frontier,” says principal investigator Michael Baria, MD, Ohio State Physical Medicine and Rehabilitation specialist.
“But there’s also been a tremendous amount of harm occurring,” he continues. “We’re standing with orthopedic organizations who say stem cell use should be confined to rigorous clinical trials at this point.”
Dr. Baria, who is board certified in sports medicine and co-leads Ohio State’s Orthobiologics program, says PRP treatments are currently the standard of care for biologic interventions for knees.
“We do a lot of PRP, with good data that it’s highly effective for knee arthritis and relatively inexpensive. Any newcomer needs to be measured against PRP. In our minds, they need to be able to outperform PRP.”
How the trial works
Funded by a national, independent entity, the single-site clinical trial will begin enrolling participants at Ohio State this fall. Dr. Baria, who is an assistant professor – clinical at the College of Medicine, and his team hope to study 120 participants, age 25 to 70, who have moderate knee osteoarthritis. They will be assigned randomly to receive either stem cell therapy or PRP treatment.
The trial will be run in strict compliance with Food and Drug Administration (FDA) standards and patients will be continuously monitored, so risk to participants will be minimal.
In both cases, the treatment will occur in one hourlong visit. Those receiving PRP will have blood drawn and processed to extract plasma with a higher-than-normal concentration of platelets. The plasma will then be injected into the knee joint.
Participants receiving stem cell therapy will have fat tissue extracted with a needle from their belly, buttock or thigh. Cells will be processed and stem cells removed from the fat and injected into the painful knee joint.
All participants will be followed for a year. Researchers will evaluate pain and function and use MRI to document whether deterioration has slowed or cartilage has regrown.
“The goal of the interventions is to preserve cartilage,” Dr. Baria says. “The older you get, the less effective these treatments become. They are ideal for the 45-year-old who has significant arthritis and needs to slow down the disease process. We’ll exclude people with bone on bone who need a knee replacement.”
He says doctors currently don’t think that cartilage regrows with PRP. Ohio State researchers are hoping to determine if the fat-derived stem cells can stimulate cartilage regrowth.
“We’re looking for longevity, duration, whether an intervention slows down degradation or regrows cartilage, and how much it costs.”