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Tissue Engineering

EB-CMF for Jaw Injuries (EB-CMF Trial)

Phase 1 & 2
Recruiting
Led By Brian R Gastman, MD
Research Sponsored by Epibone, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

EB-CMF Trial 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
  • Jaw Tumors
  • Jaw Deformity
  • Jaw Injuries

EB-CMF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events
Secondary outcome measures
Bone regeneration as assessed by high-resolution CT scans
Quality of life as measured by SF-12
Quality of life as measured by the Glasgow Benefit Inventory
Other outcome measures
Observational assessment of bone regeneration by high-resolution CT scan

EB-CMF Trial Design

1Treatment groups
Experimental Treatment
Group I: EB-CMF ImplantExperimental Treatment1 Intervention
Subject receiving EB-CMF implant

Find a Location

Who is running the clinical trial?

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

Media Library

EpiBone-CMF (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT03678467 — Phase 1 & 2
Jaw Injuries Research Study Groups: EB-CMF Implant
Jaw Injuries Clinical Trial 2023: EpiBone-CMF Highlights & Side Effects. Trial Name: NCT03678467 — Phase 1 & 2
EpiBone-CMF (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03678467 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots still available for this clinical trial?

"Affirmative. Per the clinicaltrials.gov registry, this medical investigation is actively searching for subjects to participate in it. The trial first went live on March 31st 2021 and was most recently updated on May 24th 2022; 6 people are being sought from 3 different sites."

Answered by AI

What is the upper limit of individuals participating in this clinical trial?

"Affirmative, the information published on clinicaltrials.gov reveals that this scientific research is actively recruiting participants. It was initially put up for public view on March 31st 2021 and has since been revised as of May 24th 2022 with an aim to recruit 6 individuals from 3 distinct sites."

Answered by AI

Does the age restriction of this research trial extend beyond 45 years old?

"The upper age limit for this research trial is 65 years, and the lower eligibility threshold is 18."

Answered by AI

Who qualifies to partake in this clinical experiment?

"This trial seeks 6 individuals aged 18 to 65 with mandibular injuries who meet the following criteria: a woman of nonchildbearing potential or one who consents to follow contraceptive guidance, an injury or defect due to trauma, disease, or congenital defects that is stable in nature, availability at the study centre for all assessments throughout the duration of the study period and medical history verified by either a personal physician/practitioner as appropriate plus healthy condyles suitable for titanium plating."

Answered by AI
Recent research and studies
~1 spots leftby Apr 2025