drugset / Trial / NCT04390152

Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19

NCT04390152

Phase 1/2 Terminated 6 enrolled BioXcellerator
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones, who pose a therapeutic challenge to healthcare professionals given the paucity of information we have regarding SARS-CoV-2 pathogenesis. Recently, reports mainly from China from patients treated with mesenchymal stem cells have shown promise in accelerating recovery, even in the critically ill and the therapy has sustained an increase in research because of it's powerful immunomodulatory effects, making it and interesting alternative in patients with lung and systemic inflammation. These effects could help treat a lot of patients and improve their outcomes, reason why phase I/II studies are needed to show their safety and experimental efficacy.

Timeline

Start
2020-01-13
Primary completion
2022-03-03
Completion
2022-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Wharton's jelly-derived mesenchymal stem cells Cell therapy 5e+07 cells Intravenous
Comparator Azithromycin Small molecule 500 mg
Comparator Hydroxychloroquine Small molecule 400 mg
Comparator Lopinavir Other / unclassified 400 mg
Comparator Ritonavir Other / unclassified 100 mg