FDA Approves Umbilical Cord Stem Cell Trial for Severe COVID-19 Care


The first-of-its-kind, randomized, placebo-controlled, phase 1/2a trial will assess patients hospitalized at Florida and South Dakota institutions.


The US Food and Drug Administration (FDA) has approved the start of a phase 1/2a trial assessing the use of umbilical cord mesenchymal stem cells for treating patients with severe coronavirus 2019 (COVID-19).

The 60-patient study from cell-based therapeutics company RESTEM will be the first of its kind in the US.

The cells used in RESTEM therapy candidates are grown from umbilical cord tissue through a proprietary process that replicates millions of doses in rapid succession. The Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial will identify hospitalized patients with confirmed COVID-19 and acute respiratory distress syndrome (ARDS) who could be best benefit from the therapy.

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

Patient enrollment will take place at both the Miami Cancer Institute and Sanford Health, in Florida and South Dakota, respectively. Investigators, led by Guenther Koehne, MD, PhD, deputy director of the Miami Cancer Institute, previously found benefit with the emergency use-authorized therapy in patients on ventilators.

"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,” Koehne said in a statement. “We are grateful to the FDA to have this clinical trial reviewed and approved in a timely manner during this difficult time.”

David A. Pearce, PhD, president of Innovation and Research at Sanford Health, expressed excitement at the prospect of being involved in the assessment of the already hyped therapy candidate for severe COVID-19.

"We're excited to bring a potentially breakthrough treatment to our patients with the most severe cases of COVID-19," Pearce said. "It's a privilege to partner with RESTEM on this groundbreaking approach, which has already shown remarkable promise."

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