SIOUX FALLS, S.D. (AP) - A Sioux Falls medical facility will begin a first-of-its kind clinical trial to treat rotator cuff tears using stem cells.
Patients have already started to be screened for the trial, in which Sanford Health will treat 12 people using stem cells and measure improvement compared to six other people receiving a cortisone shot.
Pioneered by Dr. Eckhard Alt in a Sanford portal clinic in Germany, stem cells are extracted from a patient’s abdominal fat and treated with an enzyme mixture before being injected around the area being treated. The hope is that the stem cells will boost regeneration of surrounding tissue and cartilage, the Argus Leader (https://argusne.ws/2igKPD2) reported.
Sanford leaders said the trial is the first to use stem cells from abdominal fat, and is designed to prove the safety of the procedure.
“The vision I have is that Sanford will legitimize the use of stem cells,” Sanford Research president Dr. David Pearce said. “There’s so much out there in terms of questions. Is this the right thing? Are they safe? We’re going to be taking the lead.”
The facility chose to start with treating rotator cuffs because they are a common injury. Patients for the trial include professional athletes.
The clinical trial is designed to show that first and foremost the procedure is safe, although it has already been proven safe in European trials. Alt said in all of his trials he has not seen any adverse effects.
The withdrawn stem cells from the abdominal fat supposedly will not make any visible difference in the patients’ appearance. Pearce said the procedure should take about two to three hours.
After safety findings are provided to the FDA, Sanford will prove the treatment is effective and begin a larger trial to include more patients.
“Once we show the safety we’re hopeful we get the green light to move to the next level, and there’s no reasons to suspect we wouldn’t,” Pearce said. “We’re trail blazing in showing how you can do this.”
___
Information from: Argus Leader, https://www.argusleader.com
Please read our comment policy before commenting.