A hub and spoke community model to equitably deliver regenerative medicine therapies to diverse populations across four California counties

The University of California, Irvine (UCI) is undergoing massive growth in size and reputation, which is paralleled by the evolution of UCI Health. The UCI Alpha Clinic (AC) was founded in 2014 with CIRM support and in partnership with UCLA. The UCI AC has established a proven track record as a conduit for basic and translational cell and gene therapy discovery in the clinical arena and attracts patients from all California. Fueled by our passion for world-class science, our dedication to finding cures by delivering transformative stem cell and regenerative medicine treatments, and our unwavering commitment to addressing health disparities and patient equity, we proposed a novel UCI AC micronetwork. The UCI AC REAL incorporates our established partners (Children’s Hospital of Orange County, Long Beach Veterans Administration Health Care, and University of California, Riverside), spans four California Counties (ORange, RivErside, San BernArdino and Los Angeles), and serves all age groups - from children to our nation’s veterans. During our first funding year we have accomplished major milestones, enabling access to CIRM-funded and FDA-authorized CTs to an increasing number of patients with unmet medical needs by building strong partners in the neighboring communities (from hospitals and Federally Qualified Health Care Centers to medical providers interested in becoming CIRM Community Care Centers of Excellence, CCCEs). We advanced our goals by employing a multi-pronged living laboratory approach in which we built a hub and spoke network model; analytically evaluated the know-how and infrastructure needed by hospitals and clinics with different levels of previous involvement in clinical research; engaged in workforce development for diverse team members (investigators, nurses, clinical research coordinators); and drove community outreach and education (community engagement studios). In each of these, we emphasized diversity, equity, and inclusion (DEI) in addressing the needs of underserved communities and all Californians. UCI AC is very involved in the efforts around the FACT accreditation standards for cell and gene therapies (CGT) in non-hematologic indications. UCI and CHOC are working on opening the first common clinical trial. UCR and UCI are collaborating on UCR efforts to prepare an application for the next CCCE infrastructure grant. The UCI AC continues to lead on all cell and gene therapy studies within UCI, serving as the conduit to translate laboratory-based discoveries into early human CTs. At the state level, our unique neurotherapeutics focus empowers us to lead the way in bringing novel regenerative therapies for neurological diseases into the AC network. Nationally, UCI AC is very involved in the efforts around the accreditation standards for high quality patient care in cell and gene therapies (CGT) leading the way to develop best practices for the implementation of these very novel therapies across the US and globally. Institutional support for the UCI ASCC remains exceptional, encompassing extensive infrastructure investments. During this funding year, we celebrated the opening and CDPH licensing of our GMP facility, which enables UCI to manufacture CGT for phase 1 and 2 clinical trials. In conclusion, the expanded operations enabled by new CIRM AC REAL funding expanded access to CTs and therapeutics for diverse and underserved CA populations. In the future years, the execution of the proposed activities and functions will result in value-added to the CIRM AC network and the regenerative medicine ecosystem in California and beyond.