The PANACEA/EVs project

The aim of PANACEA/EVs (Potency Assay and Novel Avenues for Clinical Evaluation of AngioARC or derived EV-based Therapeutics) project is to advance the clinical development and commercialization potential of AngioARC, a patented autologous mesenchymal stem cell (MSC) therapy for Critical Limb Ischemia, by establishing robust potency assays based on the mechanism of action and by exploring AngioARC-derived extracellular vesicles (EVs) as a stable, off-the-shelf therapeutic alternative. The project is planned to generate a quantitative and regulatory-compliant quality control framework to support Phase I/II clinical trials, improve product stability and batch-to-batch consistency, as well as enable scalable manufacturing and technology transfer. By integrating AngioARC potency assessment with derived EV characterization and stabilization strategies, the project seeks to overcome key logistical, regulatory, and economic limitations of autologous cell therapy, while preserving therapeutic efficacy.

HansaBioMed Life Sciences is planned to take the lead in AngioARC-derived EV manufacturing, stabilization, characterization, and quality control. Furthermore, it investigate the development of cell-free assays to be used as surrogate potency assays, providing readouts directly correlating with the analytical outputs of the in vitro potency assay(s) that will be established by the project partner Cellin Technologies.

HansaBioMed Life Sciences, Cellin Technologies