Tissue Engineered Bone for Jaw Defects
Tissue Engineered Bone for Jaw Defects
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Goal: Design and fabricate anatomic grafts and a bioreactor system to grow patient-specific tissue-engineered bone for implantation into jaw defects for an FDA-approved phase I/IIa first-in-human clinical trial.
Project Background Information
Project Background Information
Facial deformities require precise reconstruction of the appearance and function of the original tissue. The current standard of care—the use of bone harvested from another region in the body—has major limitations, including pain and comorbidities associated with surgery. Epibone's first clinical product (EB-CMF) revolutionizes the way we treat defects by growing personalized bone grafts engineered from the patient’s own stem cells.
Skills
Skills
Patient-specific implant design from CT scan data (SolidWorks)
Regulated clinical manufacturing
CFD for bioreactor flow optimization
Fabrication methods: 3D printing, CNC milling
Timeline
Timeline
March 2021 - November 2023
Collaborators
Collaborators
Surgical stakeholders:
Cleveland Clinic
UT Health San Antonio
VA Healthcare San Francisco
Internal development teams:
Engineering: 3 members
Research and Development: 5 members
Manufacturing: 4 members
Methodology
Methodology
Converted patient anatomic CT scan into patient-specific bone graft using SolidWorks.
CAD design of custom jaw graft for mandible ramus defect (≤15cc) and bioreactor components.
Utilized CNC milling to fabricate implant out of decellularized bovine scaffold.
Used CFD to optimize bioreactor design for cell growth.
3D-printed PDMS molds for bioreactor components.
CNC mill medical grade plastic (Ultem) bioreactor components.
Isolation and culture of patient stem cells from adipose tissue sample.
Perfuse graft with cell media to seed and mature stem cells into bone matrix for implantation.
Results
Results
Successfully secured, perfused, and grew tissue-engineered bone graft with living cells.
Concluded phase I/IIa clinical trial with six patient-specific grafts implanted successfully
No adverse effects were recorded in patients on year post-surgery.
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