Regenerative Stenting for Osteoporotic Vertebral Fracture Repair

Osteoporotic vertebral fractures (OVFs) are the most common complication of osteoporosis.

Current treatment involves conventional procedures that inject cement into the vertebrae to stabilise the spine and relieve pain. No reparative treatment exists.

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

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 functionalised for the controlled delivery of antioxidant lanthanides, to combat increased oxidative stress in the osteoporotic bone microenvironment, and modulate impaired bone remodelling to drive bone regeneration and facilitate repair.

The RESTORE technology has potential for use in a patient specific personalized medicine format as the 3D-printing process utilised allows for the stents to be tailored to the patient’s individual vertebra.

The hydrogel’s therapeutic load can also be adjusted and offers a potential minimally invasive prophylactic treatment for adjacent diseased vertebrae that do not yet require stenting - a first-of-its-kind prevention strategy for OVFs.

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