drugset / Trial / NCT05387278

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)

NCT05387278 ↗

Phase 1 Suspended 20 enrolled Vitti Labs, LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients. The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .

Timeline

Start
2025-03-20
Primary completion
2025-10
Completion
2025-12

Outcome

Outcome not reported

Stopped: “Sponsor request”

Drugs

EvaluationDrugModalityDoseRoute
Subject EV-Pure™ Unknown — Intravenous
Subject WJ-Pure™ Unknown — Intravenous