Project Grant R44TR005112

DEVELOPMENT OF A NOVEL TOOL THAT STANDARDIZES AND AUTOMATES THE FORMULATION OF CELL-LADEN HYDROGELS - PROJECT SUMMARY CELL THERAPIES HOLD IMMENSE PROMISE FOR TREATING DISEASES BY RESTORING FUNCTION OR CORRECTING BIOLOGICAL DEFECTS. WHILE CAR-T THERAPIES HAVE SUCCEEDED IN HEMATOLOGIC CANCERS, APPLYING CELL THERAPIES TO SOLID TISSUE DISEASES LIKE HEART FAILURE, TYPE 1 DIABETES, AND PARKINSON'S DISEASE REMAINS LIMITED BY CHALLENGES IN CELL DELIVERY-SPECIFICALLY POOR VIABILITY, LOW RETENTION, AND THE LACK OF REPRODUCIBLE, SCALABLE PREPARATION METHODS. INJECTABLE HYDROGELS HAVE EMERGED AS A SOLUTION, PROVIDING PROTECTIVE, TUNABLE MATRICES THAT ENHANCE CELL SURVIVAL AND LOCALIZATION. HOWEVER, CURRENT HYDROGEL-CELL FORMULATION TECHNIQUES ARE MANUAL, VARIABLE, AND OPERATOR-DEPENDENT, LEADING TO INCONSISTENCY IN CLINICAL OUTCOMES AND CREATING BARRIERS TO CLINICAL TRANSLATION. TO ADDRESS THIS BOTTLENECK, CELLULAR VEHICLES HAS DEVELOPED THE ODYSSEY SYSTEM-A CLOSED, AUTOMATED PLATFORM THAT STANDARDIZES THE PREPARATION AND ENCAPSULATION OF THERAPEUTIC CELLS IN INJECTABLE HYDROGELS. BUILDING ON THE SUCCESSFUL OUTCOMES OF OUR PHASE I AWARD, THIS PHASE II PROJECT WILL OPTIMIZE THE ODYSSEY SYSTEM FOR HIGH-THROUGHPUT PROCESSING ACROSS MULTIPLE HYDROGEL TYPES, FINALIZE A USER-FRIENDLY INTERFACE AND DISPOSABLE KIT, AND PRODUCE A PILOT BATCH OF SYSTEMS UNDER DESIGN-FOR-MANUFACTURE CONTROLS FOR CLINICAL VALIDATION. THE SYSTEM LEVERAGES PROPRIETARY MICROFLUIDIC MIXING AND INERTIAL FOCUSING TECHNOLOGY TO GENTLY AND CONSISTENTLY ENCAPSULATE CELLS WITH HIGH VIABILITY AND HYDROGEL UNIFORMITY, ENABLING BOTH POINT-OF-CARE AND MANUFACTURING-BASED DEPLOYMENT. BY AUTOMATING THESE CRITICAL STEPS, THE ODYSSEY SYSTEM WILL ENHANCE THE REPRODUCIBILITY, SCALABILITY, AND ACCESSIBILITY OF HYDROGEL-BASED CELL THERAPIES. UPON SUCCESSFUL COMPLETION, THIS PROJECT WILL DELIVER A CLINICAL- READY VERSION OF ODYSSEY AND POSITION IT AS A FOUNDATIONAL TOOL FOR REGENERATIVE MEDICINE DEVELOPERS AND CLINICAL PARTNERS SEEKING TO STANDARDIZE CELL-LADEN HYDROGEL THERAPY MANUFACTURING AND DELIVERY.