The HC016 platform is a treatment of acute lung injury, based on mesenchymal stem cells derived from adipose tissue (ASC), improved with proprietary Histocell technology.
Innovation
HC016 cells modulate the inflammatory process by releasing specific enzymes and growth factors.
More information
Development stage
"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 finished in December 2020.
Phase II: Randomised, controlled, double-blind. 20 patients with moderate to severe ARDS divided into 2 groups (treated and control). Phase started in December 2021.