The Stanford Alpha Stem Cell Clinic

Since its founding in February 2023, the Stanford Alpha Clinic has focused on collaborating within the network and improving patient access to cell and gene therapy. We have hired a Project Manager who is accountable for organizing working groups and communicating progress towards our objectives, and an Access Facilitator, who focuses on analyzing existing clinical trial data and suggesting and implementing strategies to bridge gaps in enrollment. Our new website, https://med.stanford.edu/alphaclinic.html, highlights all of Stanford’s cell and gene therapy clinical trials in one site so that patients can more easily find trials. Safety monitoring in cell and gene therapy is extremely important, as effects in patients may be different than expected or take a while to appear. We are proposing establishing a California Cell Therapy Safety Monitoring Committee that could offer clinical trial investigators expert advice tailored to cell and gene therapy studies and save them time when starting up new trials. We are working together with the other network sites to agree on a charter and establish this volunteer committee. As more cell and gene therapies are FDA-approved, it is vital that academic researchers collaborate to collect real-world experience from commercial use. The Stanford Alpha Clinic has drafted a template charter that members of the CIRM Alpha Clinic Network could use to establish new real world consortia for new therapies or new diseases. Real world consortia are powerful data (and sometimes sample) collection and collaboration tools to provide evidence-based knowledge to researchers and patients. We are also committed to cell and gene therapy education. Stanford currently has three fellowship programs for doctors wishing to specialize in cell and gene therapy: Pediatric Stem Cell Transplantation & Cellular Therapy Fellowship, Neuro-Immuno-Oncology Fellowship, and Blood and Marrow Transplantation- Cellular Therapy Fellowship (BMT-CT). Our manufacturing facility has both a GMP internship and a certificate program to provide training in an in-demand career. The Stanford Alpha Clinic has also begun developing a Stem Cell Counselor certificate program, which would provide a new resource to help educate interested participants on stem cell biology and cell therapy.