Periodic Reporting for period 1 - FORCE REPAIR (smart and multiFunctional 3D printable prO-Regenerative biologiCal matrix modulating mEchanotRansduction as advancEd theraPy to treAt skIn chRonic wounds)
Reporting period: 2023-01-01 to 2024-06-30
Due to population lifestyle changes, i.e. obesity, diabetes and aging population, chronic wounds (CW) which fail to follow the typical healing process is a major medical socioeconomic challenge. Current wound management is clearly insufficient and advanced therapies failed in keeping their promise of reliable skin regeneration. The aim of FORCE REPAIR is to develop a smart and multifunctional wound dressing providing pro-regenerative environment and mechanical stability to treat CW. Thus, FORCE REPAIR will combine state-of-the-art technologies in a biological scaffold tailored to patient’s needs: (1) Antibacterial and bioadhesive bioink with antibiotics and anti-inflammatory loaded nanocapsules, (2) Elastin like polypeptides promoting innervation and vascularization (3) Wharton Gel Complex preventing oxidative stress and boosting key extracellular matrix proteins. Also, the dressing activated by UV light will induce contractile force to help wound closure and activate skin regeneration. A customized 3D bioprinter with a userfriendly 3D trajectory software will help to strategically placed the biological compounds to timely address and mitigate the degenerative process occurring in CW, i.e. infection, inflammation, tension forces to promote skin regeneration. The 3D printed dressing will be tested in relevant in vitro model with a human exudate library and testing relevant key healing steps (i.e. re-epithelization, angiogenesis, cell proliferation…). Selected candidates will be tested in vivo on pig CW models and mice with bacterial infection. To ensure translation to clinical practice and reach patients, regulatory framework, HTA and a business model will be defined for a viable exploitation strategy that will decrease economic burden of wound care management and improve patients’ QoL. Finally, to ensure market acceptance health professional will guide the development of FORCE REPAIR to offer a dressing that treat efficiently CW and can be used by medical staff.
In the framework of the FORCE REPAIR project, the Elastin-like polypeptide have been now functionalized to offer methacrylate group. Meanwhile, Ibuprofen, diclofenac and mupirocin have been encapsulated in the hyaluronic acid-based capsules, showing good stability over a month. On the other hand, cross-linking of the capsules is currently under progress to adjust the release kinetics. Both compounds have been incorporated into 3D printable biomaterial.
Taking into account the regulatory framework, important work has been carried out on the production process and especially the sterilization process that will be required fort he final product. Similarly, the specification of the 3D bioprinter have been established while the first approximation on the software have been presented.
Regrading the biological evaluation of the biomaterials, the antibacterial capsules have shown a very high efficacy, even on resistant bacterial strain. Meanwhile, the best concentration of anti-inflammatory capsules is under progress.
As mentioned above, the whole development is carefully monitored by the regulatory framework. After initial analysis and comparing the different product on the market, the final product will be considered as a medical device Type III. Finally, the search in terms of economic viability of the product for the HTA studies have been uploaded to the PROSPERO database.
Taking into account the regulatory framework, important work has been carried out on the production process and especially the sterilization process that will be required fort he final product. Similarly, the specification of the 3D bioprinter have been established while the first approximation on the software have been presented.
Regrading the biological evaluation of the biomaterials, the antibacterial capsules have shown a very high efficacy, even on resistant bacterial strain. Meanwhile, the best concentration of anti-inflammatory capsules is under progress.
As mentioned above, the whole development is carefully monitored by the regulatory framework. After initial analysis and comparing the different product on the market, the final product will be considered as a medical device Type III. Finally, the search in terms of economic viability of the product for the HTA studies have been uploaded to the PROSPERO database.
At this project phase, no results obtained yet.