SUCCESS Study Tests Stem Cells COVID-19 Treatment
An experimental stem cell treatment may signal a potential path to recovery for patients experiencing acute respiratory failure due to COVID-19 disease.
A California-based biotechnology company announced it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19.
RESTEM's stem cells are grown from umbilical cord tissue by a proprietary process which allows millions of doses to be replicated rapidly. Stem cells reduce inflammation, thereby allowing tissue regeneration and healing to occur.
This stem cell 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).
After receiving individual emergency approvals by the FDA, doctors at Baptist Health partnered with RESTEM to begin the stem cell treatment. Three critically-ill COVID-19 patients were successfully treated at Baptist Health South Florida.
The newly approved multicenter, phase I/IIa study, officially known as the SUCCESS trial, will be completed in collaboration with Baptist Health South Florida and Sanford Health in South Dakota, for COVID-19 patients who have developed ARDS.
The three patients had been intubated for at least a day before they were administered the stem cells intravenously. All of these patients responded positively within days of the treatment and two have been discharged from the hospital.
The Baptist Health South Florida doctors said the intravenous treatment could be a game-changer for critically ill COVID-19 patients. Dr. Javier Pérez-Fernández, critical care director at Baptist Health said, “I’m very excited about this treatment because I really think it is going to work."
“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.”
This randomized, placebo-controlled, and blinded 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. Click here for more information about RESTEM.
COVID-19 disease therapeutic news published by CoronavirusToday.