The Food and Drug Administration (FDA) has approved a phase 1/2a study evaluating the use of umbilical cord mesenchymal stem cells for the treatment of patients with severe cases of coronavirus disease 2019 (COVID-19).
The multicenter, randomized, blinded, placebo-controlled SUCCESS (Systemic Umbilical Cord Cells to Ease Severe Syndrome) study will assess the efficacy and safety of umbilical cord mesenchymal stem cells provided by RESTEM, a cell-based therapeutics company, in hospitalized patients with severe COVID-19 (N=60). RESTEM’s cells are grown from umbilical cord tissue through a proprietary process that rapidly replicates millions of doses.
The SUCCESS study will identify COVID-19 patients with acute respiratory distress syndrome (ARDS) who would best benefit from the therapy. Patient enrollment is expected to begin this week from Baptist Health South Florida and Sanford Health.
“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.”
Use of the novel therapy for COVID-19 was based on promising results in patients previously treated at the Miami Cancer Institute under the FDA’s Emergency Use Authorization. Treatment with umbilical cord mesenchymal stem cells was associated with a reduction in both oxygen requirements and circulating inflammatory markers in 3 critically ill COVID-19 patients.