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. 

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“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.

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