Critics of PRP and stem cell therapies often point to the fact that treatments offered in regenerative medicine clinics have not undergone the FDA approval process. Setting aside the reality that said treatments do not require FDA approval for just one minute, there are a number of FDA sanctioned trials currently ongoing in the U.S. Those trials are advancing the cause of both stem cell research and current regenerative medicine therapies.
The FDA seal of approval doesn’t necessarily indicate a particular drug or treatment will work for every patient. Likewise, a lack of FDA approval for certain regenerative medicine therapies does not indicate that said therapies don’t work. It does not indicate they are dangerous either. Yet that is the implication many critics of regenerative medicine make in their arguments.
It is with that in mind that the industry looks at productive FDA trials as good for regenerative medicine. Two such trials are currently being conducted by Sanford Health based in Sioux Falls, South Dakota.
Rotator Cuffs and Ulcers
Sanford Health is currently in the midst of two stem cell trials approved by the FDA. The first is a trial that utilizes stem cells from body fat to treat tears in the rotator cuff. The second trial, and arguably the more complicated of the two, involves using stem cells to address ulcers. So far, things look good.
Sanford enrolled 18 patients in their orthopedic trial addressing rotator cuff problems. At the six-month mark, doctors report that none have experienced any adverse effects. And although researchers predict positive results in terms of efficacy, they will not say for sure how their patients have responded until the one-year trial is complete.
They have hinted at efficacy by stating that the 18 patients would have been relying on regular steroid injections in the absence of the stem cell treatment. Some of those patients would have gone on to need a surgical procedure to repair the damage.
As for the ulcer study, it is just getting started now. Doctors hope that by extracting fat cells from patients and concentrating material in a centrifuge, the resulting material injected into the site of the ulcer will promote faster and more complete healing. As it stands now, ulcers are extremely difficult to heal.
How the Process Works
Advanced Regenerative Medicine Institute (ARMI) is a Utah company that trains doctors in how use stem cell therapy and its PRP cousin to treat a variety of conditions, including orthopedic issues. The treatments are outpatient procedures that can be completed with minimal discomfort.
To treat an orthopedic injury, a doctor extracts fat tissue from the patient using a minimally invasive procedure. The fat tissue is then processed in a centrifuge to isolate and concentrate the stem cells. After processing, the stem cells are injected into the treatment site. They then signal the body to begin the healing process that, in many cases, involves regenerating new tissue to replace that which was lost or damaged.
Stanford researchers chose rotator cuff injuries for their trial because they are extremely common and very easy to monitor. Researchers are quick to point out that there is very little difference between rotator cuff tears and other joint injuries, suggesting that the results from their trial could be extrapolated and applied to similar treatments on other joints.
The industry now waits to see the results of the Sanford Health trials. Should the results be positive, and there’s no reason to suspect they won’t be, they could lead to formal FDA approval of a number of procedures already being offered in clinics around the country.