$TSOI Moving on 👍
Securing FDA Phase 3 Clearance & Expanding to All-Causation ARDS
Once the FDA received a fully defined DMF and validated cell line, TSOI moved to reformulate the clinical strategy under IND
#19757:
Shifting from COVID-19 to All-Causation ARDS: Early emergency protocols specifically targeted COVID-19 lung injury.
TSOI demonstrated that the underlying mechanism—suppression of the hyper-inflammatory "cytokine storm" and lung tissue regeneration—applied universally across all-cause ARDS (bacterial pneumonia, viral infections, physical trauma, and sepsis).
IND Refinements & Phase 3 Protocol: The FDA cleared the trial protocol under IND
#19757 (and spun off execution into Breathe Biologics) for a Phase 2b/3 multi-center trial evaluating intravenously administered UC-MSCs in adult patients with moderate-to-severe ARDS.