Stem cell treatment for rotator cuff injuries gets safety approval from FDA: Researchers in North Dakota, South Dakota lead project
FARGO — After a year-long study, the Food and Drug Administration has approved the safety of an ongoing stem cell treatment project that Sanford Health in Fargo and Sioux Falls are leading.
It's a medical advance that could eventually change the lives of millions living with partial rotator cuff tear issues, a condition affecting muscles and tendons surrounding the shoulder joint. The treatment's developers say it's one of the most common orthopedic impairments in the United States and other developed countries.
After passing the safety trial phase in December 2018, more patients from the Dakotas will be added to the next phase of the study, which if passed will grant FDA approval to market the treatment.
The treatment uses liposuction to remove fat tissue from the belly, treats it with a special enzyme and then isolates stem cells from the fat. These stem cells are called adipose-derived regenerative cells.
The cells are then injected to help repair partially torn rotator cuff injuries that impact more than a million people nationwide every year.
After one year of study, the results appear promising, but a surgeon who treats rotator cuff injuries said the treatment won't be a complete fix for all injuries.
"I have not seen any evidence anywhere that stem cells can overcome bad mechanics," said Dr. Mark Lundeen, an orthopedic surgeon at Sanford Health in Fargo. "What I tell my colleagues is that I am excited to have another tool in the toolbox — it is not the magic wand to fix everything."
One of the patients enrolled in the study said the stem cell injections led to the regrowth of a damaged tendon. Other patients reported the stem cell treatment meant more range of motion and less pain.
Dr. Lundeen said one of the biggest benefits researchers identified during the study was a reduction in inflammation.
Eighteen patients from Fargo and Sioux Falls took part in the study, in partnership with InGeneron, a Houston-based private biotechnology firm that focuses on regenerative medicine.
The next phase of the FDA approval process is a pivotal study, a trial that determines whether or nor a treatment can be marketed.
Starting soon, it will include 200 patients, and results from that could lead to more people turning to stem cell treatment instead of surgery.
Sanford Health is also working with researchers on a nationwide study that will focus on stem cell treatment and knees.
Sanford's rotator cuff stem cell treatment study is expected to be completed by late 2020, according to U.S. Library of Medicine clinical trial records.