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.

Over the course of the last year, Stanford Alpha Clinic has matured in projects, ways of working, and efficiency. The goals remain the same, increasing access to cell and gene therapy clinical trials in an equitable manner, but the scope of which the Alpha Clinic oversees has broadened and flourished. One of the biggest priorities for this year has been recognition. Our strategy in this includes attending various lab meetings to showcase what the Alpha Clinic is all about, and awareness in the community. Our Alpha Clinic is being recognized on campus and playing a part in community wide engagements. Continued collaboration with community based organizations, the Stanford Medical community, and the other Alpha Clinic sites will be the key to our success. We have chosen to focus on developing an in-depth place-based outreach and community engagement strategy that centers building sustainable and bi-directional partnerships with key community provider organizations with the overall goal of raising awareness of cell and gene therapy treatments and trials and how to gain access at Stanford. Stanford Alpha Clinic continues to make great strides in promoting cell & gene therapy trials in the Bay Area through community outreach with specific clinics in our vicinity. We have also placed an emphasis in education by hosting and attending public events that showcase the science behind cell and gene therapy, and equip future providers and scientists with the tools for a successful bench to bedside journey. In planning these education focused projects, we have identified possible areas of focus for additional events and courses. As we fine-tune various branches of our operation, we always consider the overall goal of increasing awareness to our clinical trials. Whether it be through small changes in our digital presence, or larger efforts to increase awareness amongst departments within the School of Medicine. With regenerative medicine becoming more accepted and renowned sciences, one of this upcoming year’s main strategic initiatives will be scalability. Whether it be with other Alpha Clinics or CCCE’s, expansion of the idea, resources, and audience is at the forefront of our minds.

Reflecting upon the last year, Stanford Alpha Clinic has made healthy strides towards our key pillars of advancing regenerative medicine, supporting access to clinical trials, and promoting cell and gene therapy education. We have also made refinements within our processes that will only make us more efficient in the years to come. Our research projects are making significant progress, starting from just an idea to becoming full blown qualitative and quantitative studies. This requires the help of you, the public, to ensure that we can continue this imperative work. Our goal is to provide tangible outputs, that can be referred to for years to come. Please look to the Stanford Alpha Clinic website for more information, as we plan to share information on how to get involved with a research project. We consider the following efforts will be a big priority in the next year – digital strategy, cutting edge research, and presenting our findings / outputs for the medical community to see. Starting with our website should be the go-to place for cell and gene therapy at Stanford. We have partnered with a multitude of investigators at Stanford to consolidate a list of cell and gene therapy trials going on at Stanford. This list evolves rapidly, but with our commitment in updating it regularly, the public will have the most up to date information. Our clinical trial list and associated lists with CIRM will be an easy way patients, investigators, and providers recognize our work and become aware of the innovative trials at Stanford. The research studies we conduct will spur conversation around pre- and post-curative treatment identity as well as provide physicians the proper guidance on patient assessment and are excited to formally share the outputs of these studies via seminars.