July 18, 2022
Attention News Desk: Press Release (for immediate release)
Ross Coyle | 650-725-3804
STANFORD, Calif. — Stanford Blood Center (SBC) is proud to announce that it will be joining an FDA study that could potentially lead to a change in blood donor eligibility for men who have sex with men (MSM). The FDA is currently working with LGBTQIA+ organizations and three of the largest U.S. blood centers to enroll gay and bisexual men in a study called ADVANCE (Assessing Donor Variability and New Concepts in Eligibility), with the goal of evaluating alternatives to the MSM blood donor deferral. Beginning mid-July, SBC will welcome participants who are 18 to 39 years old to enroll in the study at their research site in Palo Alto (3373 Hillview Avenue).
“Stanford Blood Center strongly supports the ADVANCE study and other data gathering methods that could lead to U.S. implementation of a more individualized risk assessment approach,” said Harpreet Sandhu, Chief Executive Officer at Stanford Blood Center. “We are honored to be one of the three enrollment sites for the study here in the Bay Area, and hope that any future deferral guidance put forth by the FDA will allow us to safely encourage more donors to give lifesaving blood products and better support local patients.”
The purpose of the study is to determine if different eligibility criteria for gay and bisexual men can be used at blood centers nationwide while maintaining the safety of the blood supply. For this to be possible, a change would need to be made to the donor history questionnaire. The current donor history questionnaire consists of a series of questions that all potential blood donors answer before donating. The questions assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV.
“The ADVANCE study is a significant step in the right direction for the LGBTQIA+ community and we’re thrilled to play a role, but there is a need for more participants. If you want to see the current MSM policy changed, we encourage you to take part in the study,” says Dr. Suchi Pandey, Chief Medical Officer at Stanford Blood Center. “SBC has long supported efforts to work with the FDA for ongoing research initiatives designed to determine whether an individual risk-based donor-screening alternative will provide equivalent transfusion safety. The primary goal of the ADVANCE Study is to provide the FDA with evidence by which to consider changes in policy from the current blood donor deferral interval for MSM.”
In April 2020, the FDA reduced the deferral period for men who have sex with men from 12 months to 3 months, and the revised deferral has been implemented at SBC. It is the hope that data from the ADVANCE study and other scientific evidence might lead the FDA to adjust its MSM guidance again to reflect a risk-based deferral model. If and when these changes take place, SBC will work to implement the changes as quickly as possible.
The study hopes to enroll a total of 2,000 participants who meet the study eligibility criteria. ADVANCE study participants will be asked questions over two study visits and provide a blood sample for testing. Participants can earn up to $85 for taking part in the study. SBC will be enrolling participants Wednesday – Friday at their Palo Alto location through September 30, 2022. To learn more about the ADVANCE study and schedule an appointment for an enrollment visit, please visit stanfordbloodcenter.org/advance.
Stanford Blood Center remains committed to maintaining a safe and adequate blood supply at all times, as well as to fairness, equality, and respect of all individuals. Eligibility information can be found at stanfordbloodcenter.org/eligibility. For any questions about deferral and eligibility, donors are encouraged to reach out giveloodSBC@stanford.edu or call 888-723-7831.
About Stanford Blood Center
Stanford Blood Center (SBC) is an independent, community blood center that supplies blood products and testing services to multiple Bay Area hospitals and is a recognized leader in the fields of transfusion and transplantation medicine. SBC was created at the Stanford University School of Medicine in 1978 to meet the complex transfusion and transplant needs of Stanford Health Care and Lucile Packard Children’s Hospital Stanford, as well as provide clinical trial services and specialized blood products for researchers. Today, the center remains locally focused, serving community hospitals, patients and donors, while contributing to research and advancement that impact the world at large. More information is available at stanfordbloodcenter.org.