May 14, 2020

Sanford Health is one of two places in the country that will begin treating some COVID-19 patients with umbilical cord stem cells as part of a first-of-its-kind clinical trial.

The U.S. Food and Drug Administration approved the 60-patient phase one and two study for RESTEM, a cell-based therapeutics company, using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19.

The study will be a collaborative effort among multiple institutions, including Sanford Health, Florida International University Herbert Wertheim College of Medicine, Baptist Health South Florida and RESTEM.

“We are excited to launch this study and demonstrate the potential of our patented umbilical cord lining stem cell (ULSC) technology,” said Dr. Rafael Gonzalez, senior vice president of research and development for RESTEM. “Based on the properties of our cells and targeted treatments, our breakthrough technology has shown promise to help those suffering from COVID-19 complications.”

The study is expected to start enrolling patients from Sanford Health and Baptist Health South Florida this week.

This treatment has already shown promising results in patients in the U.S. hospitalized with COVID-19 who also had developed acute respiratory distress syndrome, or ARDS, according to RESTEM. These patients were previously treated at Miami Cancer Institute, part of Baptist Health South Florida. The patients, who were all on ventilators, were treated with umbilical cord mesenchymal stem cells under an emergency approval from the FDA, and two have now been discharged from the hospital.

The randomized, placebo-controlled and blinded study will look at whether this may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19.

“We’re excited to bring a potentially breakthrough treatment to our patients with the most severe cases of COVID-19,” said Dave Pearce, president of innovation and research at Sanford Health. “It’s a privilege to partner with RESTEM on this groundbreaking approach, which has already shown remarkable promise.”

RESTEM’s cells are grown from umbilical cord tissue by a proprietary process that allows millions of doses to be replicated rapidly. The trial will identify COVID-19 ARDS patients who could best benefit from ULSC and will develop randomized placebo-controlled evidence about the ability of these cells to heal patients with this disease.

Patients will be able to participate in the clinical trial both at Sanford Health and the Miami Cancer Institute.