Post-Project and Supplement Period

The University of California Davis, Alpha Stem Cell Clinic (ASCC) has accomplished meeting the unmet needs of numerous patients.

• The list of clinical trials we manage in the UC Davis ASCC continues to grow. To date we manage 22 Active clinical trials and have delivered investigational products to 124 patients across our diverse list of clinical studies. Twelve of these patients came to UC Davis from outside the state of California to participate in these diverse clinical trials. The list of active studies includes protocols that require multiple infusions for the same patient, therefore we have prepared 300 investigational products. We have 25 studies that we closed out based on study numbers met or the sponsor’s request.

• ASCC now has 22 active studies and 10 potential studies In Process.

• ASCC Cell & Gene Therapy Specialists (C&GTS) are responsible for the coordination with apheresis for the bone marrow transplant and immunotherapy clinical trials, and they have managed 88 collections.

• The Clinical Operations Manager manages the inflow of new studies, maintenance of the UCD ASCC CTMS (clinical trial management system) (eVelos) and administers the IRB submissions and amendments.

• Senior CRCs continue to assist with the rising number of clinical trials managed exclusively by the ASCC, as well as a Clinical Research Nurse to assist with the navigation of the various inpatient departments along with outpatient infusions.

• Through the efforts of Telemedicine to meet the ongoing need of continuing clinical operations at UC Davis during the 2020-2022 covid-19 pandemic, we have also increased the use of the technology in the novel cell and gene therapy clinical trials that come into the UC Davis ASCC, Cancer Center and other Departments within the UC Davis Medical Center.

• UC Davis has implemented technology for the prescreening activities for some of the cell and gene therapy clinical trials that have eligibility criteria that are difficult to meet. These specific clinical trials are being managed through the UC Davis Cancer Center and ASCC is coordinating efforts with them.