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Sanford Health Opens First-in-the-Nation Trial to Treat COVID-19 with Stem Cells

Sep 09, 2020 11:10AM ● By MED Magazine

Sanford Health, the largest provider of rural healthcare in the country, today announced it has opened a Phase 1/2a trial using umbilical cord lining stem cells (ULSCs) to treat patients with moderate to severe cases of COVID-19, both prior to being placed on a ventilator as well as after requiring ventilator support. The study is the first of its kind in the U.S.

“We’re committed to bringing the best treatments and discoveries to our patients first,” said David A. Pearce, PhD, president of innovation and research at Sanford Health. “We are thrilled to be the first health system in the country to open this trial and offer access to a novel treatment option to our patients with severe cases of COVID-19.”

The randomized, placebo-controlled and blinded study will look at whether infusing patients with ULSCs may be a safe and effective treatment for COVID-19. The trial also aims to identify the population that will benefit most optimally by enrolling patients with moderate to severe COVID-19.

“We are optimistic about the potential improvement with this treatment,” said Dr. W. Chad Spanos, MD, principal investigator of the clinical trial at Sanford Health. “We look forward to enrolling more patients onto this trial and bringing promising new treatment options to our patients’ bedside in the future.”

The trial has already enrolled five patients at Sanford USD Medical Center in Sioux Falls, South Dakota and may expand to Fargo, North Dakota.

“It’s a pleasure to work with Sanford Health and their team of professionals,” said Dr. Rafael Gonzalez, senior vice president of research & development for RESTEM. “We have spent many years researching the properties of ULSCs in order to assure we are delivering the best quality cells that may provide a robust response. We look forward to the results of the study.”

RESTEM’s cells are grown from umbilical cord tissue by a proprietary process that allows millions of doses to be replicated rapidly.