Clinical study to assess the safety and preliminary efficacy of HCR040, a drug based on mesenchymal stem cells, in patients with acute respiratory distress syndrome. (included patients COVID-19)

Phase 1

• Conditions: acute respiratory distress syndrome; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002688-89-ES
• Lead Sponsor: Histocell S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-26
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

–Men and women = 18 years
–Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
–Patients with invasive mechanical ventilation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

–Participation in a previous clinical study within 28 days prior to the ARDS situation.
–Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation.
–Inability to obtain Informed Consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified