NCT03678467

Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction

An Open-Label, First-in-Human, Single Intervention Study for Evaluation of EpiBone-CMF Engineered Living Bone Graft for Mandibular Ramus Reconstruction

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Epibone, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells. This first in human trial is designed specifically to assess the safety of EB-CMF clinically. Although secondary measures of graft efficacy are being assessed, the primary focus will be on Adverse Events stemming from graft implantation.

Conditions

• Mandible Tumor
• Mandibular Injuries
• Mandible; Deformity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	EB-CMF	Autologous, anatomically shaped bone graft

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-08-01
• Completion: 2023-11-01
• First posted: 2018-09-19
• Last updated: 2022-05-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study