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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 10, 2019

Primary Completion Date

August 16, 2021

Study Completion Date

February 27, 2022

Conditions
Acute Respiratory Distress Syndrome
Interventions
DRUG

HCR040 (Phase 1)

(Phase 1) Intravenous administration. Open label dose escalation, 3 patients in cohort 1 (1 million cells/kg) and 3 patients in cohort 2 (2 million cells/kg)

DRUG

Placebo (Phase 2)

(Phase 2) Intravenous administration of vehicle solution

DRUG

HCR040 (Phase 2)

(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)

Trial Locations (2)

28040

Fundación Jiménez Díaz, Madrid

48903

Hospital Universitario de Cruces, Barakaldo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Histocell, S.L.

INDUSTRY