Status:
ACTIVE_NOT_RECRUITING
Functionalized Bioink Delivering Biomolecules for the Treatment of Craniofacial Diseases
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Craniofacial Defects, Subtle
Skull Defect
Eligibility:
All Genders
Up to 50 years
Brief 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...
Detailed Description
To develop a mouldable biosynthetic collagen-based polymer matrix, commercial gelatin-methacrylamide (GelMA)-based hydrogels will be biochemically modified to finely tune their pseudo-plasticity and y...
Eligibility Criteria
Inclusion
- Paediatric patients (0-3 years) undergoing surgery for craniosynostosis and other inborn defects/trauma/brain tumors
- Adult patients (18-50 years) undergoing craniofacial surgery for (mainly) trauma and tumours
Exclusion
- Paediatric patients older than 3 years of age
- Adults older than 50 years of age
- Paediatric patients and adult patients with other cranial diseases
- Patients with cranial defects that do not require craniofacial surgery
Key Trial Info
Start Date :
October 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06533150
Start Date
October 7 2024
End Date
October 1 2026
Last Update
March 14 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC neurochirurgia Infantile
Roma, Italy, 00168