INJECTHEAL · MULTIFUNCTIONAL SELF-HEALING INJECTABLE HYDROGEL FOR CHRONIC WOUND HEALING AND TISSUE REGENERATION

Chronic wounds affect over 305 million people worldwide, significantly reducing quality of life, accounting for 2-4% of EU healthcare costs. Current treatments for deep cavity chronic wounds lack a comprehensive strategy to tackle issues including wound reachability, infection control, inflammation reduction, vascularization, tissue regeneration and scalability. INJECTHEAL introduces a ground-breaking multi-functional, green 4D injectable self-healing hydrogel, based on functionalized pectin and gelatin, serving both as a delivery vehicle for therapeutics and a matrix to promote healing through its biomimetic properties and controlled bioresorption. The hydrogel platform includes antibacterial (e.g., octenidine), anti-inflammatory and pro-angiogenic (e.g., Ac2-26 peptide and siRNAs) agents, to provide effective formulations viable for industrial exploitation. Hydrogel properties are tailored by biocompatible poly(epsilon-lysine) dendrons allowing (i) fine tuning of hydrogel crosslinking degree and (ii) versatile bulk functionalization with bioligands to support cell adhesion, migration and angiogenesis. Immune-stealth polymeric microcapsules, embedded in the hydrogel, protect cell-targeted dendrons, loaded with sensitive agents, from enzymatic degradation enabling their controlled, sustained and precise delivery. Preclinical safety and efficacy assessment according to GLP are set with progressive complexity to reproduce human-relevant pathophysiological features of chronic wounds, from ISO standard in-vitro 2D cell trials and antimicrobial assays to novel in-vitro tests in proprietary human-relevant 3D skin models, human wound exudates and in-vivo animal chronic wound models. Scale-up production, business planning, consultation with key notified regulatory agencies and early involvement of end-users (incl. patients) will provide a preclinically-validated industrial socio-economical sustainable hydrogel platform ready for post-project first-in-man clinical trials.