The University of California Davis, Alpha Stem Cell Clinic (ASCC) has met all milestones and has accomplished meeting the unmet of numerous patients and have instructed Clinical Fellows for future medical professionals in the world of novel cell and gene therapies:
The list of clinical trials we manage in the UC Davis ASCC continues to grow. To date we manage 21 Active clinical trials and have delivered investigational products to 111 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 193 investigational products. We have 17 studies that we closed out based on study numbers met or the sponsor’s request.
ASCC now has 21 active studies and 6 potential studies In Process.
ASCC Patient Coordinators/Cell & Gene Therapy Specialist (C>S) are responsible for the coordination with apheresis for the bone marrow transplant and immunotherapy clinical trials, they have managed 60 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. In addition to providing the oversight of the Clinical Research Coordinators, who conduct 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 2020-2021 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 the technology for the prescreening activities for some of the cell and gene therapy clinical trials that have eligibility criteria that is difficult to meet. These specific clinical trials are being managed through the UC Davis Cancer Center and ASCC is coordinating efforts with them.
UC Davis has 6 CIRM Clinical Fellows who have successfully met the goals of the UC Davis/CIRM Cellular Therapy Training Program. This wasa two-year program designed to provide a solid foundation in conducting clinical cellular therapy research for junior investigators working to improve human health. Candidates simultaneously applied to the UC Davis Clinical Research (GCLR) Graduate Group to pursue a Master of Advanced Study (M.A.S.) in Clinical Research degree while participating in the training program. Each class of Cell Therapy scholars began their work in the Summer along with the next MCRTP cohort, followed by two years of continuing coursework and mentored research, ending in June two years later. Selected scholars needed a 70%-time commitment to complete the training program and the requirements for the Clinical Research master’s degree.
Reporting Period:
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>S) 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.
Grant Application Details
Application Title:
Alpha Stem Cell Clinic for Northern and Central California
Public Abstract:
The UC Davis Alpha Clinic will provide pivotal resources to assist in the approval & conducting of stem cell/regenerative medicine clinical trials. A centralized space & personnel to administer the therapies to patients in the UCD 33-county catchment region (~6 million people in Northern/Central CA)
Statement of Benefit to California:
Thanks to infrastructure & funding provided by CIRM, stem cell/regenerative medicine clinical trials at our institution are ongoing or recently completed for: HIV, osteopenia, swallowing disorders, retinopathy, disc repair, spine pain, critical limb ischemia, heart disease, non-healing ulcers, burn injuries, cartilage repair & traumatic brain injury. Our outstanding TeleHealth program will help other Alpha Clinic sites extend coverage for trials to the northern and central regions of California.
