Principal Investigator: LTC(R) Luis M. Alvarez, PhD
Performing Organization: Theradaptive, Inc.
Topic Area and Background: This proposal advances products to treat maxillofacial trauma sustained during combat. Complex maxillofacial and mandibular trauma is difficult to treat in forward environments due to limitations in current medical technology. The ability to rapidly produce an anatomically customized implant on demand that leads to rapid and robust bone regeneration would transform dental care in forward areas.
Objective: The objective for the Phase I/II study, named RESTORE (REgenerative patient Specific Therapeutics for CMF REpair), is to evaluate OsteoAdaptTM DE’s safety and performance in comparison to standard of care (xenograft particulate bone graft) for alveolar ridge augmentation. This Feasibility study (45 patients) will inform the endpoints of a statistically powered pivotal clinical study in order to obtain PMA approval for the lead indication of segmental mandibular defect repair.
Patients requiring a single tooth extraction (with the intent of placing a dental implant into the regenerated bone in the extraction socket) that meet study eligibility requirements will be randomized into one of three study arms prior to the extraction procedure at a 1:1:1 ratio (15 patients each) – Control vs. Investigational (low dose or high dose OsteoAdaptTM DE). Subjects will be blinded to their arm allocation whereas the treating physician will be unblinded (Single blinded study). Primary outcome measures will be assessed after 6 months; this includes evaluating successful placement of a dental implant with primary stability, comparing rates of serious adverse events, and the occurrence of any unplanned additional procedures at the implantation site related to the grafting material and/or grafting procedure.
Theradaptive has developed a platform that enables the production of on-demand anatomically personalized regenerative implants that can fully regenerate large segments of the facial anatomy. This platform can produce customized implants on demand in less than 24 hours. Theradaptive has partnered with 3D Systems, the world’s leading healthcare 3D printing company, to combine their existing Virtual Surgical Planning (VSP) platform with Theradaptive’s osteoinductive 3D device, OsteoAdaptTM DE. In January 2024, the FDA granted Theradaptive IDE approval to commence a Phase I/II clinical study in vertebral fusion (see NCT06154005 on clinicaltrials.gov). Theradaptive will leverage the device master file (DMF) to submit an IDE in maxillofacial repair in support of this project.
Applicability: CMF emergencies continue to be a threat to overall readiness in both deployed and peacetime environments. Published studies of military personnel have reported that between 26% to 75% of these emergencies cannot be prevented. Many of these emergencies involve complications with the underlying bone and require treatments that can only be delivered in advanced care settings. The treatment we propose here would enable these restorative procedures to be completed without the need for advanced techniques in forward areas and with significantly accelerated regeneration thus leading to faster return to duty rates.