A Phase 2/3 interventional study of MultiStem and Placebo in ARDS, sponsored by Healios K.K.. Terminated at 4 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Healios K.K. · Phase 2/3, Interventional, and Treatment
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection
Exclusion Criteria:
Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
Biological: MultiStem
Biological: Placebo
intravenous infusion
intravenous infusion
Ventilator-Free Days
Time frame: Day 0 through Day 28.
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Time frame: Day 28
All-cause mortality
Time frame: Day 60
Ranked hierarchical composite outcome of alive and ventilator-free
Time frame: Day 28
Ventilator-free days
Time frame: Day 0 through Day 60
Plan to share: No
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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Healios K.K.