MedTrace Logo

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

NCT04289194 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-28

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • Histocell, S.L.

    lead INDUSTRY

Principal Investigators

  • Fermin Labayen Beraza, MD · Hospital de Cruces

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289194 on ClinicalTrials.gov