Alpha Stem Cell Clinic for Northern and Central California

The UC Davis Alpha Stem Cell Clinic (ASCC) has successfully implemented procedures for improved operations and streamlined processes for conducting cell and gene therapy clinical trials. The ASCC has played a leading role in the increased number of cell and gene therapy protocols enrolled in at UC Davis Health by providing the infrastructure needed for these complicated trials. The ASCC grant funding provided the ability to expand the successful operation and provided support for even more centralized activities. It also provided the financial support critical to programs that enhance patient recruitment and adherence to protocol requirements; improvement in time/efficiency of the administration of trial therapeutics; initiation of training for new support staff and the provision of regulatory support. UC Davis Health (UCDH) and ASCC serve patients throughout Northern and Central California. Our catchment area represents approximately 6 million people with many lacking access to cell and gene therapies. Our physicians are committed to ensuring these patients are referred to only legitimate sites, avoiding dangerous unregulated clinics where non-FDA approved stem cell applications can cause more harm than good. The UC Davis ASCC along with the Alpha Clinic Network sites continue to work collectively to ensure that stem cell and gene therapy clinical trial resources and access are available to a diverse patient population throughout the state of California. The ASCC provides an excellent value proposition for both patients and trial sponsors, by leveraging the success of the UC Davis Stem Cell Program and Gene Therapy Center through the number of cell-based clinical trials brought to UCDH with the connections established. Patients receive exceptional care and support from highly trained ASCC staff members with a long history of working together coordinating clinical projects involving cooperation between different departments. Clinical trial sponsors benefit from rigorously designed and efficiently run clinical trials with a diverse patient population to draw from, as well as opportunities for continued collaboration. The ASCC has fostered strong relationships with statewide and national medical program networks, has a commitment to enhance access to stem cell and gene therapy clinical trials, is dedicated to developing novel therapies for patients with rare diseases and works alongside the NIH-funded consortium of CTSC/CTSA academic research institutions. Through these resources the UC Davis ASCC has the ability to increase the overall value of the Alpha Clinic Network. These resources also serve to expand our extensive portfolio of ongoing and planned clinical trials, creating more opportunities to develop stem cell and regenerative medicine cures for Californians.

The UC Davis Alpha Stem Cell Clinic (ASCC) has successfully implemented procedures for improved operations and streamlined processes for conducting cell and gene therapy clinical trials. The ASCC has played a leading role in the increased number of cell and gene therapy protocols enrolled in at UC Davis Health by providing the infrastructure needed for these complicated trials. The ASCC grant funding provided the ability to expand the successful operation and provided support for even more centralized activities. It also provided the financial support critical to programs that enhance patient recruitment and adherence to protocol requirements; improvement in time/efficiency of the administration of trial therapeutics; initiation of training for new support staff and the provision of regulatory support. The ASCC physicians are committed to ensuring that patients are referred to only legitimate sites, avoiding dangerous unregulated clinics where non-FDA approved stem cell applications can cause more harm than good. The ASCC staff provide an excellent value proposition for both patients and trial sponsors, by leveraging the success of the UC Davis Stem Cell Program and Gene Therapy Center through the number of cell-based clinical trials brought to UCDH with the connections established. Clinical trial sponsors benefit from rigorously designed and efficiently run clinical trials with a diverse patient population to draw from, as well as opportunities for continued collaboration. The UC Davis ASCC along with the Alpha Clinic Network sites continue to work collectively to ensure that stem cell and gene therapy clinical trial resources and access are available to a diverse patient population throughout the state of California. The ASCC has fostered strong relationships with statewide and national medical program networks, is dedicated to developing therapies for patients with rare diseases and works alongside the NIH-funded consortium of CTSC/CTSA academic research institutions. The resources available to the ASCC also serve to expand our extensive portfolio of ongoing and planned clinical trials, creating more opportunities to develop stem cell and regenerative medicine cures for all Californians including those in underserved communities. The collaboration between the Alpha Clinic Network and the GMP manufacturing network has achieved significant strides in operational efficiencies and accelerated activities, resulting in streamlined treatment delivery and improved coordination across the therapeutic pipeline. These achievements demonstrate our commitment to enhancing patient outcomes while optimizing resource utilization. Operational efficiencies through the Alpha Clinic Network and the GMP Manufacturing Network collaboration: • Cost Reduction and Financial Audit Insights: the significant cost reduction stems from process optimizations, resource sharing, and strategic infrastructure utilization within the GMP manufacturing network. These savings not only make these advanced therapies more accessible but also highlight the financial sustainability of our collaborative manufacturing model, demonstrating that high-quality, life-saving therapies can be delivered at a cost that supports broader patient access and healthcare equity. • Enhanced Fresh Infusion of CAR T Products: the introduction of a fresh CAR T product infusion model, supported by improved cryopreservation and thawing coordination, provides significant benefits to patients. • Better Understanding of Patient Needs Close collaboration with other Alpha Clinics and clinical teams has deepened our understanding of patient requirements. This alignment enables personalized treatment approaches and fosters a patient-centric model, ensuring therapies are designed and delivered with their unique needs in mind. • Improved Communication Between Manufacturing and Hospitals Regularly scheduled cross-disciplinary meetings and the integration of digital communication tools have strengthened collaboration between manufacturing teams and hospital systems. This improvement has led to more synchronized therapy delivery timelines, reduced logistical challenges, and enhanced overall operational efficiency. Conclusion The partnership of the UC Davis Alpha Clinic and GMP exemplifies the transformative potential of collaborative networks in advancing cell and gene therapy manufacturing. By integrating streamlined processes, innovative technologies, and patient-focused strategies, the Alpha Clinic Network and GMP have created a model that delivers faster, more cost-effective, and higher-quality treatments. These outcomes significantly enhance patient care and set a benchmark for excellence in regenerative medicine.