HC016 cells modulate the inflammatory process by releasing specific enzymes and growth factors.
"In vivo" Poc study finished with promising results.
"In vivo" Safety regulatory study finished with good safety profile.
Phase I/II clinical trial for Acute Respiratory Distress Syndrome (ARDS) was approved by the Spanish Agency of Medicines and Medical Devices in December 2019.
Phase I: Dose escalating Phase I study in 6 patients with moderate to severe ARDS inluded in 2 sequential cohorts.
Phase II: Randomised, controlled, double-blind. 20 patients with moderate to severe ARDS divided into 2 groups (treated and control).
Recruiting starts: Q2 2020.