Primary Treatment: EB-CMF · No Placebo Group · Phase 1 & 2
Experimental Group · 1 Intervention: EB-CMF · Intervention Types: CombinationProduct
Screening: ~3 weeks
Reporting: 10 years
Who is running the clinical trial?
Epibone, Inc.Lead Sponsor
Brian R Gastman, MDPrincipal InvestigatorThe Cleveland Clinic
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.
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.