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Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction

NCT03678467 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-05-27

No results posted yet for this study

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

COMBINATION_PRODUCT

EB-CMF

Autologous, anatomically shaped bone graft

Sponsors & Collaborators

  • Epibone, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian R Gastman, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-08-31
Completion
2023-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678467 on ClinicalTrials.gov