Development of a novel tool for cell therapies that automates the formation and injection of cell-laden hydrogels directly into tissue - Project Summary
Cell-based therapies hold immense potential to revolutionize medicine by offering personalized, curative
treatments for patients. However, their efficacy to date has been hampered by challenges in successfully
delivering cells to target tissues. Standard-of-care intravenous infusion delivers cells systemically, which works
for blood-based diseases, but not for solid tissue diseases; cells become trapped in filtering organs and never
reach the target. Injecting liquid cell suspensions directly into tissue does not work well either, as cells
experience death and lack of retention within the tissue. A potential solution is to encapsulate the cells in
hydrogels, which are 3d structures which can act as protective carriers. Beyond helping cells to survive the
injection process, hydrogels can also increase the likelihood that cells engraft within the tissue, as they can be
designed to anchor to the extracellular matrix (ECM) in the tissue, or to eventually dissolve, leaving behind
cells that have integrated in the ECM. One class of hydrogels in particular - shear-thinning hydrogels - provide
a promising mix of mechanical properties for clinical applications. The challenge, however, is that formation
and encapsulation of these hydrogels is extremely variable, and manual methods have not been reproducible
enough to allow for clinical translation.
Cellular Vehicles Inc. is proposing the development of a system to automate and standardize the
production of ‘cells in hydrogel’ preparations. Building on our prior success developing the Odyssey System for
automation of ‘cells in media’ preparations, we, along with our collaborators at Drexel University, will work
together to develop a novel version for this product for cell-laden hydrogel therapies. This project will push
forward a novel, automated method to formulate, encapsulate, and inject cell-laden hydrogels with increased
consistency, with the goal of eventually improving cell survival and retention in the diseased tissue. The
project's aims include developing an automated method for hydrogel mixing, designing a protocol that achieves
uniform cell encapsulation, and assessing the success of injection through clinically relevant formats.
Successful completion of this project will lead to a Phase II project during which we will advance the
scalability and robustness of the technology, aiming to optimize the automated process for larger-scale
contexts while ensuring consistently high cell viability and homogenous hydrogel formulations. The Phase II
project will include preclinical testing in an animal model to evaluate the safety and capability of the automated
cell-laden hydrogel delivery system to inject into tissue. These advancements will position the technology to be
submitted to the FDA Class II 510(k) de novo pathway. FDA approval will lead to partnerships with cell therapy
developers, and clinical translation. Overall, the outcome of this research will greatly advance the clinical
potential of cell-based therapies, particularly for treating solid-tissue diseases.
