Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction (NCT03678467) | Clinical Trial Compass
UnknownPhase 1/2
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction
United States6 participantsStarted 2021-03-31
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Patients must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
✓. Stable mandibular ramus injury or defect due to trauma, disease, or congenital defects.
✓. Medical history must be verified by either a personal physician or medical practitioner as appropriate.
✓. Patient determined by the Investigator to be a suitable candidate by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation.
✓. A female patient is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least 1 of the following conditions applies:
✓. A woman of nonchildbearing potential (WONCBP) as defined in Appendix 6. OR
✓. A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance in Appendix 6 for at least 1 month prior to surgery, during the treatment period, and until 12 weeks after completion of the study.
✓. Patient must be available at the study center for all specified assessments throughout the study duration.
Exclusion criteria
✕. Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation.
✕. Mandibular ramus defects with open wounds.
✕. Defects \> 15 cc in volume.
What they're measuring
1
Number of participants with treatment-related adverse events
✕. Systemic disease that would render the fat harvest and product implantation, along with associated anesthesia, unsafe to the patient.
✕. Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data.
✕. Active uncontrolled infection or malignancy. Patients will be allowed to undergo rescreening once, after the infection is cleared, if they are willing to do so.
✕. Patients with signs and symptoms of infection between Screening and up to the surgical implantation.