EB-CMF for Mandibular Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mandibular Injuries+2 More
EB-CMF - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to assess the safety of a new type of bone graft, created from the patient's own stem cells. The primary focus will be on any adverse events that occur from the implantation.

Eligible Conditions
  • Mandibular Injuries
  • Mandible Tumor
  • Mandible; Deformity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mandibular Injuries

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 10 Years

10 Years
Observational assessment of bone regeneration by high-resolution CT scan
12 months
Bone regeneration as assessed by high-resolution CT scans
Number of participants with treatment-related adverse events
Quality of life as measured by SF-12
Quality of life as measured by the Glasgow Benefit Inventory

Trial Safety

Safety Progress

1 of 3

Other trials for Mandibular Injuries

Trial Design

1 Treatment Group

EB-CMF Implant
1 of 1
Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: EB-CMF · No Placebo Group · Phase 1 & 2

EB-CMF Implant
CombinationProduct
Experimental Group · 1 Intervention: EB-CMF · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years

Who is running the clinical trial?

Epibone, Inc.Lead Sponsor
Brian R Gastman, MDPrincipal InvestigatorThe Cleveland Clinic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The study patient is determined to be suitable based on a review of their medical history, physical examination, laboratory tests, and cardiac evaluation by the study Investigator.
A woman who is not able to have children and agrees to use contraception for the duration of the study.
Patients must be 18 to 65 years old to qualify for the study
Misalignment or abnormality of the jawbone due to an injury, disease, or birth defect.
The patient must be available at the study center for all the specified assessments throughout the study duration.
Before enrolling in this study, all patients must sign a written informed consent form, which outlines the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, as well as in accordance with the Declaration of Helsinki
Most patients who have blood work done as part of a routine checkup will fall within the reference range for healthy individuals
The person's medical history must be verified by a personal physician or another medical practitioner.
The text describes a healthy condyle, which can be treated with titanium plates and screws.
A defect in the ramus of the mandible which starts below the sigmoid notch and does not extend as far as the angle.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.