Spots Global Cancer Trial Database for Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction
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Trial Identification
Brief Title: Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction
Official Title: An Open-Label, First-in-Human, Single Intervention Study for Evaluation of EpiBone-CMF Engineered Living Bone Graft for Mandibular Ramus Reconstruction
Study ID: NCT03678467
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
VA Healthcare System, San Francisco, San Francisco, California, United States
Cleveland Clinic, Cleveland, Ohio, United States
UT Health San Antonio, San Antonio, Texas, United States
Contact Details
Name: Brian R Gastman, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
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