Diseases and Abnormalities at or Before Birth

All Conditions

Neoplasms

Musculoskeletal Diseases

Mouth and Tooth Diseases

Nervous System Diseases

Wounds and Injuries

Symptoms and General Pathology

Congenital Abnormalities

Mandibular Neoplasms

Mandibular Injuries

Maxillofacial Injuries

Facies

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Autologous, anatomically shaped bone graft

EB-CMF

Brian R Gastman, MD

Rebeka Silva, DMD, FACD

Beverly Doyle

Erin Locke, BSN, RN

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.

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

Yearly observation of bone regeneration by high-resolution CT scan until the subject withdraws from the study or termination of the study.

To assess the safety of EB-CMF for up to 12 months post surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction.

To assess the efficacy of the EpiBone-CMF graft for up to 12 months post-surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction. Bone regeneration as assessed by high-resolution CT scans for up to 12 months post-surgery.

To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by the Glasgow Benefit Inventory.

To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by SF-12.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.

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