Researchers at Pitt are developing a preclinical evaluation of a novel off-the-shelf biologic device designed to regenerate large volumes of bone by leveraging a combination of minimally manipulated autologous mesenchymal stem cells (MSCs), hydrogels, nanoparticles, specific cytokines, and porous scaffolds. This comprehensive approach aims to mitigate the critical limiting factors in bone repair, such as cellular progenitors, vascular supply, and immune response, offering a promising alternative to traditional therapies.
Description
Depending on the nature of the bone injury, the device can be applied in two forms: An injectable hydrogel which is suitable for treating comminuted fractures and small bone deficits. This form helps stabilize bone fragments and accelerates the initiation of regeneration. Or as an implantable hydrogel-infused scaffold, designed for larger bone deficits. This form combines all components to provide structural support and enhance bone formation while minimizing non-union and fibrosis risks.
Applications
- Treatment of compromised bone wounds
- Bone fracture treatment
Advantages
A significant innovation highlighted is the use of a cartilaginous intermediate, which is more resilient to the hostile conditions of compromised wounds. This cartilaginous stage aids in modulating the patient’s immune response, fostering a more conducive environment for subsequent bone and tissue formation. This approach is a departure from existing clinical devices that rely predominantly on anabolic factors like BMP-2 (used in INFUSE) and BMP-7 (used in OP-1 implants), which are generally effective only in optimal fracture models.
Invention Readiness
This technology is at the level of in vivo data. Preclinical evaluations involve models using Yorkshire swine to assess the device's efficacy. The studies test the injectable device in bi-lateral simulated comminuted fractures of the fibulas and the implantable device in bi-lateral fibular segmental defects. Outcomes of interest include bone formation and strength, revascularization, reinnervation, and both local and host immune responses, compared to current standards of care.
IP Status
https://patents.google.com/patent/US20210213170A1
