Objectives

GreenNanoBone’s main objective is to develop and validate the use of sustainable, biocompatible, bioactive and antimicrobial 4D materials which can be printed or injected to prevent and treat Medication-Related Osteonecrosis of the Jaw (MRONJ), with several sub-objectives:

• Develop a sustainable 4D hydrogel from plant-derived nanoparticles manufactured from food waste streams that can be injected for easy delivery or printed as a personalised scaffold for implantation, shaped and sized according to the specific patient.

• Manufacture the delivery system for injection and printing of scaffold and to scale up the production in a sustainable and efficient manner following Good Manufacturing Practice (GMP) standards.

• Determine the appropriate pharmacological doses of 4D injectable and printed GreenNanoBone hydrogels. Evaluate their effects on the immune system, angiogenesis, bone and gum tissue regeneration in both healthy and oncology-compromised conditions, using in vitro and in vivo models. Investigate antibacterial properties of the hydrogels.

• Contribute to advancing the fundamental understanding of the underlying mechanisms of Medication-related Osteonecrosis of the Jaw (MRONJ) in oncology patients and develop 3D in vitro MRONJ models.

• Build social and economic foundations for introducing GreenNanoBone into clinical practice by developing communication materials to ensure societal acceptability and informed decision-making in relation to GreenNanoBone and conducting a cost of illness study to estimate the financial impact of GreenNanoBone on health systems.

• Define the regulatory pathway of the GreenNanoBone product following EU relevant regulations such as Medicinal Product Directive (2001/83/CE) and ATMP or combined ATMP regulation (EC 1394/2007) with the intention to reach Clinical Phase I (TRL6) by the end of the project.