A comprehensive stem cell and gene therapy clinic to advance new therapies for a diverse patient population in California

We have successfully completed all necessary start-up activities, establishing a strong foundation for our involvement in various clinical research projects. We are currently in discussions with a CIRM-funded sponsor about becoming a site for their trial, having already identified the principal investigator (PI). In addition to potential site engagements, we have supported the submission of a few CIRM grant applications. Some of these grants include being a clinical trial site and community outreach, while for others, we are providing cell manufacturing, monitoring, data management and DSMB services. This period has been marked by strategic engagements and successful collaborations, establishing us as a versatile and reliable partner in the clinical trial ecosystem, poised for further growth and engagement in this vital sector of medical research. During the reporting period, we have also undertaken several key educational activities to support education and training in collaboration with the Clinical and Translational Research Center. A significant milestone was the establishment of a 12-week Clinical Research Coordinator Training Program with the CTRC. The curriculum was meticulously designed to cover essential aspects of clinical research coordination. Additionally, substantial progress has been made in the development of a Master’s Program in Regenerative Medicine, which is now transitioning into the marketing phase. We have also identified a target population for a specialized nursing training program, focusing on developing content that is comprehensive, up-to-date, and relevant to nursing practice in regenerative Medicine. Our comprehensive outreach and engagement strategy has focused on supporting community and patient education and engagement, with a particular emphasis on increasing access and inclusion in clinical trials. We have made presentations at support groups, covering various aspects of cell therapy development, the FDA process, and clinical trial phases. These presentations stressed the importance of diversity in trial participants, aligning with DEI objectives to ensure trial results are representative and applicable to a broader patient population. Additionally, we discussed current regenerative medicine trials and extended our educational efforts to Spanish-speaking clinics to ensure non-English speaking patients have equal access to information. These initiatives were designed to demystify the clinical trial process and increase patient willingness to participate in trials, thereby supporting broader recruitment goals. These efforts reflect our commitment to enhancing our clinical trial capabilities, fostering professional development, and enhancing patient and community engagement in medical research. Through these strategic engagements and educational initiatives, we are not only contributing to the advancement of medical research but also ensuring that our efforts are inclusive and representative of the diverse populations we aim to serve.

The Cedars Sinai Alpha Clinic continues to support the overall mission outlined by CIRM to in collaboration with our 8 other Alpha Clinic network partners to “accelerate the development and delivery of transformative regenerative medical (RM) treatments” to all Californians in an equitable and patient focused fashion. To this end we have made significant progress in several key areas: We continue to pursue novel cellular approaches to the treatment of neurological and cardiopulmonary conditions. We have published our Phase 1 data in the areas of pulmonary arterial hypertension and amyotrophic lateral sclerosis in high impact journals and continue more advanced testing in these areas. We have also assisted other investigators in grant applications and regulatory FDA submissions. We have expanded our investigational pharmacy support for RM trials We continue to highlight our RM educational programs. We have now an approved program to provide a Master’s degree in RM and have also formulated curricula for Clinical RM Fellows, Research Coordinators, Nursing and other educational collaborations with our network partners. We also provided key training and mentorship to high school students. We continue to offer support to our network partners and others in the areas of manufacturing, novel imaging, advanced proteomics (analysis of tissue of single cell protein profiles), artificial intelligence and regulatory support (e.g. monitoring of clinical trials, assistance with language translations, single IRB reliance mechanisms etc). We continue to be highly active in community outreach and education of the community and specific patient focused diagnostic support groups. We also hosted, together with CIRM, the annual 2-day Alpha Clinics Symposium at Cedars Sinai, which was well attended both in person and virtually and which obtained outstanding reviews. In keeping with our efforts directed at equity and inclusion we have spoken about RM at clinics supporting Spanish and Korean patients. We work closely with our renowned and expansive community focused oncology group at Cedars. We are also heavily engaged in driving the write up of the expansive and highly innovative work done by the CIRM Alpha Clinic Network since 2023 , which we intend to publish in an outstanding medical journal, which has both national and international recognition.