3D‑printed bone scaffolds to repair cleft lip and palate defects
Clinically Applicable Orofacial Cleft Reconstruction Using Structural, Compositional Biomimetic Bone Scaffolds
['FUNDING_R01'] · WAKE FOREST UNIVERSITY HEALTH SCIENCES · NIH-11145623
Developing 3D‑printed, bone‑like scaffolds to help children with cleft lip and palate heal bone defects without needing bone taken from another part of their body.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | WAKE FOREST UNIVERSITY HEALTH SCIENCES (nih funded) |
| Locations | 1 site (WINSTON-SALEM, UNITED STATES) |
| Trial ID | NIH-11145623 on ClinicalTrials.gov |
What this research studies
This project makes 3D‑printed scaffolds that mimic the structure and composition of natural bone and are shaped to fit orofacial (alveolar) defects. The scaffolds are designed to recruit a child’s own stem/progenitor cells in place rather than being pre-loaded with cells. Researchers will test these scaffolds in clinically relevant animal models that mimic human cleft defects to see if they reliably regenerate bone. The work aims to reduce the need for autologous bone grafts, donor‑site surgeries, and unpredictable graft loss, as a step toward future human treatments.
Who could benefit from this research
Good fit: Children with alveolar or other orofacial bone defects from cleft lip/palate who would otherwise be candidates for autologous bone grafting.
Not a fit: Patients whose problems are limited to soft‑tissue clefts, those with active infection or poor wound healing, or those needing immediate clinical intervention may not benefit from this scaffold approach.
Why it matters
Potential benefit: If successful, the approach could allow bone repair for children with clefts without harvesting bone from elsewhere, cutting down surgeries, pain, and donor‑site complications.
How similar studies have performed: Related 3D‑printed and bone‑mimicking scaffold approaches have shown promise in laboratory and preclinical animal work, but applying cell‑free biomimetic scaffolds specifically for orofacial clefts in clinically relevant models is still relatively new.
Where this research is happening
WINSTON-SALEM, UNITED STATES
- WAKE FOREST UNIVERSITY HEALTH SCIENCES — WINSTON-SALEM, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: LEE, SANG JIN — WAKE FOREST UNIVERSITY HEALTH SCIENCES
- Study coordinator: LEE, SANG JIN
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.