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.
Grant Application Details
Application Title:
A comprehensive stem cell and gene therapy clinic to advance new therapies for a diverse patient population in California
Public Abstract:
We aim to markedly expand access of all Californians to outstanding cell and gene therapy trials for multiple conditions with unmet treatment needs. We will also contribute with excellence to the other network sites in advancing all aspects of regenerative medicine.
Statement of Benefit to California:
As an ASCC, we will help advance the field for multiple diseases with unmet needs to bring novel treatments to patients. Californians with devastating conditions will be able to enroll in early and later stage cell and gene therapy clinical trials.
