The City of Hope Alpha Clinic: A roadmap for equitable and inclusive access to regenerative medicine therapies for all Californians

We have proposed a phased expansion in our Alpha Clinic, initially delivering stem cell and regenerative medicine therapies in satellite clinics and, eventually, in outlying communities. First, we invest in community integration and education, working with key stakeholders and placing patient navigators in community settings. To this end, we have hired a patient navigator who is helping educate patients and providers at our community satellite centers. We are excited at the recent CMS determination permitting reimbursement of patient navigation services, and look forward to leveraging that reimbursement to make these efforts even more robust. Additionally, we are organizing Community Advisory Boards to help understand how we can be most helpful to the communities we serve. Second, we provide resource and logistical support for patients and families while creating the infrastructure required to treat them closer to home. We are excited that the CIRM Patient Assistance Program is coming on line soon, and look forward to offering this to our patients. We are also working with our satellite sites to bring innovative trials to patients in those locations. Third, we provide comprehensive training and support for a regenerative medicine workforce based in the community. Working closely with our sister institutions, we have developed a field-leading Nursing Education program to be held in April, 2024. Finally, we continue our groundbreaking work on developing and translating exciting new therapies to the clinic. In this reporting period, COH Alpha Clinics is supporting COH clinical trial operations office, Cell and Gene Therapy Center, and Laboratory for Cellular Medicine to accelerate clinical trials, provide process development, regulatory and GMP manufacturing for City of Hope investigator-initiated and industry-sponsored trials. There are 58 cell and gene therapy trials currently open to accrual at City of Hope, due in large part to the support of the Alpha Clinic.

We have proposed a phased expansion of our Alpha Clinic, initially delivering stem cell and regenerative medicine therapies in satellite clinics and, eventually, in outlying communities. Although we have encountered substantial obstacles to this overall goal, we remain on track to deliver on our objectives within the five year timeframe. We continue to invest in community integration and education, working with key stakeholders and broadening the geographic reach of our patient navigators in community settings. Alpha Clinic representatives continue to participate in workforce education, participating in training courses at City of Hope and in our peer institutions. The future may bring stronger headwinds in building infrastructure to reach underserved Californians, but the Alpha Clinic Network will remain critical in defining standards for providing the best care to all Californians. We have previously provided resources and logistical support for patients and families while creating an infrastructure to treat them closer their to homes, and are excited that the CIRM Patient Assistance Program is coming online this year. We look forward to offering this to our patients. We also continue to work with our satellite sites to bring innovative trials to patients in those locations. As mentioned above, we continue to train and support the regenerative medicine workforce, both at City of Hope and across California. The Immune Effector Cell center holds quarterly Immunotherapy Research Staff Symposiums, 4-hour workshops devoted to delivering the best evidenced-based regenerative medicine care. Alpha Clinic representatives also help to educate nurses and physicians through the City of Hope Clinical Investigator Training Program, through UCI's ACCTITP, and through the Irell and Manella Graduate School, Southern California Association of Pediatric Hematology/Oncology Nurses Annual Meeting, and other regional outlets. Finally, we continue to support groundbreaking work on developing and translating exciting new therapies to the clinic. In this reporting period, our Alpha Clinic has provided support to the City of Hope Clinical Trial Operations office, the Center for BioInnovation and Manufacturing, and the Laboratory for Cellular Medicine. We have supported the hiring of 13 new clinical trial staff members focused on stem cell and regenerative medicine therapies. Our manufacturing team continued to play an important role in process development and the production of GMP-grade viral vectors and clinical products across various therapeutic areas. Notably, the team has manufactured 31 clinical products for approximately 20 studies, for both industry partners and City of Hope investigators. Additionally, our regulatory team facilitated the filing of 11 INDs (including 2 for cell therapy) and 3 pre-INDs (2 for cell therapy). Currently, there are 52 cell and gene therapy trials open to accrual at City of Hope, including 7 newly initiated studies.