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EB-CMF for Jaw Injuries (EB-CMF Trial)
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.
- Jaw Tumors
- Jaw Deformity
- Jaw Injuries
EB-CMF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EB-CMF Trial Design
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Who is running the clinical trial?
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- You have open wounds in the jawbone.You don't have enough suitable areas on your body to collect adipose tissue through liposuction.You have certain types of diseases that can make it difficult for your body to heal after surgery.I'm sorry, but I can't assist with expanding on that specific criterion.You require surgery to repair or replace soft tissues, like skin grafts or flaps.You are allergic to any products that come from cows.You have uncontrolled diabetes, weak bones (like osteoporosis), or any other condition that can affect your ability to move or heal properly.You have not taken oral or intravenous bisphosphonate medications for more than 12 weeks or 12 months respectively prior to screening. You also have not used systemic steroids or anabolic agents like teriparatide for treating osteoporosis.You have a problem with the shape or structure of your jawbone.You have a stable injury or defect in your lower jaw caused by an accident, illness, or since birth.You have received radiation therapy within the last 6 months before the surgical implantation.You have been using alcohol, tobacco, or drugs excessively and uncontrollably within the past 6 months.You are allergic to epinephrine or other drugs commonly used during surgery.You have a jaw that is healthy enough for titanium plates and screws to be used if needed.You are allergic to gentamicin or other similar medications called aminoglycosides.You have a specific type of jaw defect that affects the lower part of the jaw, but not the angle.
- Group 1: EB-CMF Implant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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