drugset / Trial / NCT04289194

Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

NCT04289194 ↗

Phase 1/2 Completed 26 enrolled Histocell, S.L.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.

Timeline

Start
2019-12-10
Primary completion
2021-08-16
Completion
2022-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject HCR040 Unknown 1 cells/kg Intravenous
Subject HCR040 Unknown 2 cells/kg Intravenous