FDA Approves COVID-19 Trial Using of Umbilical Stem Cells

Two lab technicians suit up to begin the process of testing samples for COVID-19 on the campus of Miami Cancer Institute

RESTEM, a leading cell-based therapeutics company, announced it has received approval from the U.S. Food and Drug Administration for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. Patients will be able to participate in the SUCCESS clinical trial both at Miami Cancer Institute and at Sanford Health. The study will be the first of its kind in the U.S.

“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 & 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.”




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 (ARDS). These patients were previously treated at Miami Cancer Institute, part of Baptist Health South Florida, under the care of principal investigator Guenther Koehne, MD, PhD, deputy director of the Miami Cancer Institute. The patients, who were all on ventilators, were treated with umbilical cord mesenchymal stem cells under an emergency approval from 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.

The multicenter phase I/IIa study, officially known as the Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial, will be completed in collaboration with Baptist Health South Florida in Miami, Florida and Sanford Health in Sioux Falls, South Dakota, for COVID-19 patients who have developed ARDS.

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

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

“Based on the initially observed improvement of the patients treated, we are now looking forward to enrolling these severely ill patients onto the clinical trial. We are grateful to the FDA to have this clinical trial reviewed and approved in a timely manner during this difficult time,” said Dr. Guenther Koehne who is also the chairman of the Department of Translational Medicine at Herbert Wertheim College of Medicine (HWCoM) at Florida International University and the principal investigator of this clinical trial.

Sanford Health will also be a key strategic partner for this study. “We’re excited to bring a potentially breakthrough treatment to our patients with the most severe cases of COVID-19,” said David A. Pearce, PhD, 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 SUCCESS 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.

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