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.
HCR040 is an investigational medicinal product whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2. The main purpose of this study is to evaluate the safety and tolerability of a single administration of HCR040 using: a) two sequential escalating doses administered 96 hours post-injury to participants with moderate to severe acute respiratory distress syndrome (ARDS); and b) the determined maximum tolerated dose administered 96 hours post-injury to participants with moderate to severe ARDS. The study also includes initial exploration of efficacy. Treatment is administered by intravenous injection. The study has been divided into two phases: Phase 1 (open label): 6 participants with moderate to severe ARDS will be included in 2 sequential cohorts. Phase 2 (randomized, controlled, double-blind): 20 participants with moderate to severe ARDS will be randomly divided into two groups (control and treated).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
(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)
(Phase 2) Intravenous administration of vehicle solution
(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Fundación Jiménez Díaz
Madrid, Spain
Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection
Time frame: One year
Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040
Time frame: Day 28
Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040
SOFA index from 0 to 4 where lower scores represent improvement
Time frame: Day 28
Mechanical ventilation-free days 28 days after the administration of HCR040
Time frame: Day 28
Percent mortality 28 days after the administration of HCR040
Time frame: Day 28
Daily pulmonary mechanics values (Ppl, DP, CRS)
Time frame: One year
Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040
Murray scale from 0 to 4 where lower scores represent improvement
Time frame: Day 28
Vasopressor-free days 28 days after the administration of HCR040
Time frame: Day 28
ICU-free days 28 days after the administration of HCR040
Time frame: Day 28
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