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Functionalized Bioink Delivering Biomolecules for the Treatment of Craniofacial Diseases

NCT06533150 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-03-14

No results posted yet for this study

Summary

The study aims to address the challenges of craniofacial bone reconstruction in pediatric and adult patients affected by congenital craniofacial malformations (i.e. craniosynostosis), trauma or tumors, by developing an innovative biohybrid material with tunable rheological properties, serving as a sealing agent and defect filler. Craniectomy/craniotomy procedures often leave bone defects that require cranioplasty to protect the underlying dura mater and the brain from physical insults. Reconstruction of the viscerocranial skeleton poses additional challanges, due to the complex anatomy of the facial skull and significant esthetic and functional demands on its reconstruction.

The study plans to develop a mouldable biosynthetic gelatin-methacrylamide (GelMA)-based hydrogel complexed with functionalized Poly (lactic-co-glycolic acid) (PLGA) nanoparticles for drug delivery. Osteoprogenitors cells (including mesenchymal stromal cells/osteoblasts and monocytes/osteoclasts) will be isolated from bone tissue fragments of enrolled patients and peripheral blood sample, respectively, to obtain 2D and 3D cultures mimicking the in vivo bone environment. High-throughput profiling of patients' samples will identify druggable targets for the bioactive compounds to be released by the bioink. In vitro validation will involve osteoprogenitor co-cultures derived from patients to assess uptake, release dynamics, biocompatibility, immunogenicity, and therapeutic effects of the developed complex. The final goal will be to develop a pre-prototype tissue engineering biocomposite for craniofacial bone reconstruction.

Conditions

  • Craniofacial Defects, Subtle
  • Skull Defect
  • Craniosynostoses

Interventions

OTHER

multiomic profiling

2 aliquots of patients-derived bone tissue specimens (collected as surgical waste from routinely surgeries) will be collected and exploited from proteins and metabolites isolation according to standardized protocol. Then, samples will be digested using Filter-aided sample preparation digestion protocol and analysed by Liquid Chromatography Tandem Mass Spectrometry. Peptides will be loaded on the PepMap 100 C18 trap cartridge, and subsequently separated on an EASY Spray C18 analytical column. The mass spectrometer, equipped with a nanoESI spray source, operates in positive ion polarity and MS/MS mode. Also metabolites will be assessed by LC-MS/MS and will be separated by HPLC. Obtained results will be analyzed by integrated pathway analysis (IPA) to achieve the multiomic profiling of each patient thus identifying druggable targets to be exploited in drug design. The selected biomolecules will be then tested in patient cells using the developed bioink-nanoparticle complex.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Luca Massimi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2025-12-31
Completion
2026-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533150 on ClinicalTrials.gov