Regenerative Stenting for Osteoporotic Vertebral Fracture Repair

Introduction

Osteoporotic vertebral fractures (OVFs) are the most common complication of osteoporosis. Current treatment involves conventional procedures that inject cement into the vertebrae to stabilize the spine and relieve pain. No reparative treatment exists.

Challenges in Biomaterial Treatments

Biomaterial-based treatments have had very limited success due to a number of complex challenges, such as:

• Providing dual therapeutic and mechanical functionalities to meet clinical requirements.

Proposed Solution: RESTORE

Building on a wealth of experience in the area of materials processes, we propose the solution. RESTORE will initially overcome the problems with traditional biomaterials approaches by:

1. Utilizing recent advances in the area of advanced manufacturing and 3D-printing.
2. Engineering a dual component biomaterial platform, comprising:
   • A 3D-printed biodegradable stent.
   • A thermoresponsive hydrogel, with mechanical properties and bioactive composition tailored to regenerate and repair osteoporotic vertebral bone.

Functionalization of Hydrogel Component

Following this, and consolidating the research in the applicant’s lab on biomaterial-mediated delivery of therapeutics to enhance bone formation and inhibit resorption, the hydrogel component will be functionalized for:

• The controlled delivery of antioxidant lanthanides.
• Combating increased oxidative stress in the osteoporotic bone microenvironment.
• Modulating impaired bone remodeling to drive bone regeneration and facilitate repair.

Personalized Medicine Approach

The RESTORE technology has potential for use in a patient-specific personalized medicine format as the 3D-printing process utilized allows for:

• The stents to be tailored to the patient’s individual vertebra.
• The hydrogel’s therapeutic load to be adjusted.

This offers a potential minimally invasive prophylactic treatment for adjacent diseased vertebrae that do not yet require stenting, representing a first-of-its-kind prevention strategy for OVFs.

Conclusion

The proposed RESTORE platform is thus a paradigm-shifting disruptive technology that will revolutionize the way damaged osteoporotic vertebrae are treated.