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Bringing hydrogel-based craniofacial therapies to the clinic
Alen Trubelja1, F Kurtis Kasper2, Mary C Farach-Carson3
1Department of Diagnostic and Biomedical Sciences, School of Dentistry, UTHealth Science Center at Houston, Houston, TX 77054, United States; Department of Bioengineering, Rice University, Houston, TX 77005, United States.
This review details the advancement of hydrogels in craniofacial soft tissue engineering, from simple fillers to complex cell-laden constructs. It proposes a framework for hydrogel development, considering regulatory pathways for clinical translation.
Area of Science:
- Biomaterials Science
- Regenerative Medicine
- Tissue Engineering
Background:
- Hydrogels are increasingly utilized in craniofacial soft tissue engineering.
- Current clinical applications are often limited to simple aesthetic fillers.
- Significant pre-clinical advances in hydrogel technology are not yet translated to clinical practice.
Purpose of the Study:
- To review the evolution and complexity of hydrogels in craniofacial soft tissue engineering.
- To present a hierarchy for hydrogel systems based on complexity and regulatory considerations.
- To assess the impact of regulatory pathways on the translation of hydrogel technologies.
Main Methods:
- Literature review of hydrogel applications in craniofacial soft tissue repair.
- Analysis of biofabrication methods and their historical context.
- Examination of regulatory pathways, including Food and Drug Administration (FDA) approval.
Main Results:
- Hydrogel complexity ranges from acellular fillers to advanced cell-laden constructs.
- Function-driven architectures inspired by native tissue organization are emerging.
- A hierarchy is proposed for classifying hydrogel systems for craniofacial applications.
Conclusions:
- Advanced biofabrication methods enable complex hydrogel systems for tissue repair.
- Translating pre-clinical hydrogel technologies requires navigating complex regulatory pathways.
- A framework is presented to guide future hydrogel development towards clinical translatability and FDA approval.
