FDA approves clinical trial exploring the use of umbilical cord stem cells to treat severe cases of COVID-19
In the wake of the pandemic, the FDA approves multiple clinical trials exploring stem cells as a treatment option for COVID-19. The SUCCESS trial aims to explore the safety and efficacy of umbilical cord stem cells.
COVID-19 has infected more than 3 million people in the U.S. alone. Due to the impact this pandemic continues to have on social and economic well-being, finding ways to treat and prevent the spread of COVID-19 effectively is imperative.
In May 2020, the U.S. Food and Drug Administration (FDA) approved a clinical trial examining the use of umbilical cord stem cells to treat COVID-19. The approval was backed by preliminary findings where three critically ill COVID-19 patients, who had developed acute respiratory distress syndrome (ARDS), were successfully treated with umbilical cord stem cells under an emergency approval from the FDA.
The goal of the newly announced SUCCESS clinical trial (Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19) is to determine whether ARDS patients will benefit from umbilical cord stem cells.
This phase 1/2a clinical trial is the first of its kind to be conducted in the U.S. It will be a collaboration between Baptist Health South Florida in Miami, Florida, and Sanford Health in Sioux Falls, South Dakota.
Acute respiratory distress syndrome (ARDS) and COVID-19
In most cases, symptoms of a coronavirus infection would be similar to those of the common cold. But in some instances, it can lead to severe respiratory symptoms. ARDS is one such instance where fluid buildup in the air sacs of the lungs deprives the body of oxygen.
Patients who show COVID-19-associated ARDS symptoms often require ventilator support and are at higher risk of severe consequences, including mortality. According to one study, approximately 50% of patients diagnosed with COVID-19-associated ARDS perish from the disease. Given this high fatality rate finding new treatment options is key to saving lives.
A phase 1/2a clinical trial looking at umbilical cord mesenchymal stem cell treatment in patients with COVID-19-associated ARDS
The preliminary study was conducted by Dr. Koehne, the principal investigator involved in the SUCCESS trial. Three COVID-19 patients on ventilators were infused with umbilical cord lining-derived stem cells intravenously. The patients showed significant improvements in symptoms within days of infusion and have since been discharged from the hospital.
Based on these observations, the FDA has now approved a larger clinical trial, which will involve 60 patients.
This randomized, placebo-controlled, and blinded study will identify whether umbilical cord stem cell infusions are a safe and effective treatment option for patients with COVID-19-associated ARDS.
If successful, this trial will identify a much-needed treatment option for a subgroup of severely affected patients who are at higher risk of mortality from COVID-19.
Umbilical Cord Mesenchymal Stem Cells Used to Successfully Treat 3 Critically Ill COVID-19 Patients. StemCellPortal. April 2020.
Breakthrough Regenerative Therapy Approved by FDA for COVID-19 Study Focuses on Patients with ARDS. TrialSiteNews. MAY 16, 2020.
Fan, E, Beitler, JR, Brochard L, et al. (2020) COVID-19-associated acute respiratory distress syndrome: is a different approach to management warranted? Lancet Respire Med. doi:https://doi.org/10.1016/ S2213-2600(20)30304-0.
Wu, C, Chen, X, Cai, Y et al. (2020) Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020;180(7):934-943. doi:10.1001/jamainternmed.2020.0994.