Cellular Therapy Facility
Leaders in Cellular Therapy
As a pioneer in cellular therapy, our facility produces, processes, preserves, protects, and provides cells for use in patient care and research throughout our health system. We handle hundreds of cell products each year allowing Stanford Health Care to offer advanced treatments and innovations for conditions such as cancer, stroke, neurological disorders, and diabetes.
WHAT WE OFFER YOU FOR CELLULAR THERAPY
- Applications in a wide range of conditions currently offered or being studied, including cancer, organ transplants, neurological diseases, heart conditions, and more. Go to Conditions Treated
- Supporting leading-edge treatments such as chimeric antigen receptor (CAR) T cell therapy that uses a person’s own T cells to target and destroy a tumor. Go to Treatments
- Team approach with highly experienced technicians, and technologists. Go to Your Care Team
Stanford Hospital is ranked among the Best Hospitals in America by US News & World Report
In our facility, we are advancing the applications of cell products by enabling clinical care plans that incorporate cellular therapy and by supporting numerous clinical trials exploring the value of cellular therapy for a wide spectrum of conditions:
Cancers, including:
- Acute lymphoblastic leukemia (ALL)
- Acute Myeloid leukemia (AML)
- Germ Cell cancers
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
- Myelodysplastic syndromes (MDS)
- Multiple myeloma
Noncancerous conditions, including:
- Diabetes, Type 1
- Heart conditions
- Hematologic genetic diseases
- Neurological conditions
- Organ transplants
- Stroke
Preparation of a safe and effective cellular therapy product
Our cellular therapy facility is highly regulated to collect and process cell and biological products. It is one of the few cell production facilities located on the campus of an academic medical center. Managing cell selection, purification, and modification enables us to develop new cellular therapy techniques and technologies quickly and efficiently. Our licensing and regulatory status include:
- Registration with the Food and Drug Administration (FDA) under FDA 21CFR1270/1271 to collect and to process hematopoietic cell products (HCT/P).
- Licensed with the State of California for Biologics Production, Tissue Bank, and New Drug Manufacturing activities.
- Accreditation with the Foundation for the Accreditation of Cellular Therapy (FACT).
- Regulated under the Association for the Advancement of Blood and Biotherapies (AABB) Cellular Therapy Standards.
- Contracted with the National Marrow Donor Program (NMDP)/Be the Match Network Transplant Center as a Marrow and Apheresis Collection Center.
Our facility meets or exceed all safety and quality standards and reliability. Our state-of-the-art facility controls the collection, receipt, processing, short term and long term storage, product tracking, labeling, and release of all products.
Our team members are skilled scientists dedicated to the production of cellular and biological products and ensure the safety and quality of every unique production.
Your cells are powerful and personal. We treat them – and you – with the utmost respect.
We handle all cell collections for which people donate cells for their own treatment to help rebuild their immune systems after cancer treatment.
We also handle cell collection from donors or from cord blood to prepare for stem cell transplants and cell therapies. Some cell collections require additional processing in our facility prior to patient cell transplant or therapy.
Your Cellular Therapy Facility Team
In our state-of-the-art facility, our teams provide complete care customized to your specific condition and needs. We are committed to your safety, comfort, convenience, and recovery.
Technologists
Our technologists are responsible for:
- the meticulous processing of cellular materials, including sampling, freezing and storage
- transporting the cellular product to patients and assisting in infusion preparation
- ongoing training in new technologies and therapies
Quality Team
This team helps ensure that you get a safe and effective product by:
- Prescribing operating standards within the cellular therapy facility
- Ensuring compliance with international, national, and state regulartory standards
- Documenting control and management, and data management of each collection and manufacturing process
- Overseeing sterile processes, equipment calibration, and storage device maintenance
Support Professionals
Our management, administrative, and laboratory team ensures efficient and compliant operation of our facility. Our management team has many years of experience in the cellular therapy field in both hospital and industry settings.