Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)

One of the hallmark features of the progression of COVID‐19 is lung injury from the viralinfection leading to potentially acute respiratory distress syndrome (ARDS) andrespiratory failure requiring ventilator support. In patients who survive ARDS,regardless of the pathology, there is evidence that their long‐term quality of life isadversely affected.The rationale for the dose and dosing regimen proposed in this study is based on the safeadministration and benefits of this treatment regimen reported to us last year byphysicians trying to treat moderate to severe COVID‐19 patients. In those reports, theintravenous route of administration was used. It has been reported that dosing every 2days amplified the benefit of the combination of exosomes and mesenchymal stem cells. Ithas been suggested based on clinical experience that the exosomes and MSCs arecomplementary to one another as well as enhancing the innate abilities of both.During the early days of the pandemic, intravenous infusion of a mixture of EV‐Pure™ andWJ‐Pure™ was reported to benefit hospitalized patients with moderate to severe COVID‐19related ARDS. This study is designed to systematically explore the risk and benefits ofintravenous infusion of EV‐Pure™ and WJ‐Pure™ in the treatment of hospitalized COVID‐19patients with moderate to severe ARDS.This is a proof of concept, double‐blind, placebo‐controlled trial to evaluate the safetyand efficacy of intravenous infusion of EV‐Pure™ and WJ‐Pure™, versus placebo, for use inthe treatment of moderate to severe ARDS related to COVID‐19. This is an add‐on treatmentstudy; subjects will be allowed to take standard of care treatments available.The study will have two arms (n=10 each): 1. Experimental/treatment arm: EV‐Pure™ and WJ‐Pure™ plus standard care 2. Placebo: Cryopreservation media plus standard careThe study duration would be 5 days of treatment plus 12 weeks follow up.