# Clinically Applicable Orofacial Cleft Reconstruction Using Structural, Compositional Biomimetic Bone Scaffolds

> **NIH NIH R01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $686,229

## Abstract

PROJECT SUMMARY/ABSTRACT
Orofacial clefts are one of the most prevalent craniofacial birth defects in humans, which are characterized by
incomplete formation of oral and facial structures that separate the nasal and oral cavities. These congenital
disorders, if not successfully managed with a series of surgical interventions on lips, alveolus, hard/soft palates,
may lead to critical abnormalities of children’s growth development of the maxillary and the midface, insufficient
speaking, impaired respiratory function, and psychosocial problems such as low self-esteem. In current clinical
practice, the gold standard treatment for hard tissue reconstruction such as cleft palate with alveolar cleft is most
commonly involved with autologous bone graft; however, autologous tissue grafts are limited in availability,
require additional invasive surgery, and have donor site morbidity. More critically, the major shortcomings of the
autologous bone grafts include significant bone loss after grafting and their unpredictable success rate. In this
proposed project, our central hypothesis is that structurally, compositionally biomimetic bone scaffolds without
cell seeding could utilize host stem/progenitor cells for in situ orofacial cleft reconstruction. Thus, the objective
is to investigate the clinical feasibility of this novel bone scaffolding system using a clinically relevant animal
model for orofacial cleft reconstruction. To achieve this, we will utilize 3D bioprinting technology to fabricate a
personalized bone scaffold with clinically relevant size, shape, and structural integrity. In addition, we will utilize
a noninvasive real-time near-infrared (NIR) fluorescence imaging platform to monitor mineralization for bone
regeneration along with scaffold degradation. We also hypothesize that this NIR imaging platform can provide a
comprehensive understanding of the relationship between scaffold degradation and in situ bone regeneration.
The central hypothesis will be tested by pursuing three Specific Aims: 1) Develop and characterize
compositionally biomimetic bone scaffolds for in situ orofacial cleft reconstruction; 2) Develop a novel
noninvasive monitoring system using NIR-functionalized bone scaffolds; 3) Validate 3D bioprinted
biofunctionalized bone scaffolds in a clinically applicable rabbit orofacial cleft defect model. Upon conclusion, we
will develop a clinically relevant 3D bioprinting workflow that can be utilized for orofacial cleft reconstruction. With
our successful completion of this project, we will apply this novel approach toward the creation of personalized
bone grafts as an effective treatment for orofacial clefts in children.

## Key facts

- **NIH application ID:** 10520847
- **Project number:** 1R01DE031285-01A1
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Sang Jin Lee
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $686,229
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10520847

## Citation

> US National Institutes of Health, RePORTER application 10520847, Clinically Applicable Orofacial Cleft Reconstruction Using Structural, Compositional Biomimetic Bone Scaffolds (1R01DE031285-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10520847. Licensed CC0.

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