Preliminary results from emergency authorization use have shown promise for patients
Sioux Falls, SD September 8, 2020 – 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.
About Sanford Health
Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health’s transformative work to improve the human condition at sanfordhealth.org or Sanford Health News.
RESTEM is a leading-edge biotechnology firm dedicated to the discovery and development of cell-based therapeutics and tools that aid in the treatment of human degenerative disorders. The company focuses on improving the quality of life for those who suffer from disabling diseases of the immune system and other severe infirmities. With over 12 years of research and development on umbilical cord lining stem cells (ULSCs), which have properties of mesenchymal stem cells, RESTEM has emerged as a major contributor to cell-based therapy treatments based on the unique properties of its patented cell technology.