drugset / Trial / NCT04447833

Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome

NCT04447833 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.

Timeline

Start
2020-06-17
Primary completion
2021-01-30
Completion
2026-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject KI-MSC-PL-205 Cell therapy 1e+06 cells/kg —
Subject KI-MSC-PL-205 Cell therapy 2e+06 cells/kg —