A small clinical trial has shown that autologous stem cells derived from a patient’s own body fat can significantly reduce osteoarthritis knee pain for up to a year with no serious side effects, according to findings published in the American Journal of Sports Medicine.
A total of 39 patients participated in the Phase 2 placebo-controlled trial at Tulane University School of Medicine, where researchers injected SVF stem cells – stromal and vascular cells derived from adipose fat tissue -- into the knees of osteoarthritis patients. Some participants received placebo injections.
"Our randomized, controlled clinical trial is the first cellular therapy study for osteoarthritis to meet study endpoints using autologous adipose stromal cells for a point-of-care therapy. Eighty-eight percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function," said William Cimino, PhD, CEO of GID BIO, which funded the study. GID BIO develops cellular therapies for degenerative musculoskeletal, dermal and other chronic diseases.
SVF therapy is controversial because it is not yet FDA-approved. Some clinics currently using SVF cells are in the crosshairs of the FDA, with ongoing federal litigation in Florida and California. That’s what makes the new study findings significant.
"Publishing this data signifies real science and a breakthrough in regenerative medicine. We've completed a prior safety trial, an FDA-approved Phase 2b trial, and are now beginning a Phase 3 pivotal trial. Physicians will be able to use the SVF-2 technology to provide a cellular therapy option for patients," said principal investigator Jaime Garza, MD, Professor of Orthopedic Surgery at Tulane University School of Medicine.
Interestingly, Garza is a former star football player at Tulane whose fledgling NFL career was cut short by nagging knee injuries. As PNN has reported,regenerative cell therapies are increasing in popularity among NFL players and other professional athletes, who often have chronic pain from lingering injuries.
Knee osteoarthritis (OA) is the most prevalent joint disease in the United States, affecting nearly 1 in 5 Americans aged 45 years and older. Since the mid-20th century, knee OA has doubled in prevalence, due primarily to age and obesity. Women are more likely than men to have knee OA and have more severe pain.
Total knee arthroplasty – a procedure that attempts to restore function by resurfacing the knee joint – is the only surgical intervention for knee OA. Other treatments include anti-inflammatory medications, physical therapy and steroid injections. The FDA is also considering a new drug application for tanezumab, a biologic drug that blocks pain signals from reaching the brain.
“While current nonoperative modalities can offer symptomatic relief, these treatment modalities often fail, ultimately leading to knee arthroplasty. There is a need for more effective nonoperative knee OA treatment modalities, especially ones that may arrest or even reverse disease progression,” wrote Garza.