EUCTR2019-002688-89-ES
Active, Not Recruiting
Phase 1
Phase 1/2 clinical study to assess the feasibility, safety, tolerability and preliminary efficacy 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. (included patients COVID-19)
Histocell S.L.0 sites26 target enrollmentJuly 26, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acute respiratory distress syndrome
- Sponsor
- Histocell S.L.
- Enrollment
- 26
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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