KHI Workgroup Opportunity
Xenotransplantation: Knowledge and Perception Assessment
Abstract
The advent of genome editing techniques has empowered xenotransplantation researchers to potentially overcome the rejection of xenogeneic organs by the immune system. This has created an opportunity for using modified porcine kidneys as a potential source of viable organs for patients with end-stage kidney disease. But the patient and health care communities have a diversity of perceptions on this approach for kidney replacement. A clear baseline of current perceptions is needed by the innovator community to design first-in-human studies that address these concerns and perceptions. This project aims to inform first-in-human xenotransplantation trials by engaging the research and development communities, care partners, and patients to assess current knowledge and perceptions of this potentially powerful technology.
Deliverables
Key concepts that convey xenotransplantation first-in-human trials for sponsors, including toolkits for effective communications with key stakeholder groups.Timeline
First phase completion goal: 1Q2022Workgroup Members
| Steering Committee | Melanie Blank, MD | US Food and Drug Administration |
| Steering Committee | Karen Jackler, MPH | US Food and Drug Administration |
| Steering Committee | Anne Rowzee, PhD | US Food and Drug Administration |
| Member | Mary Baliker | Patient Advocate |
| Member | Vanessa Evans | Fresenius Medical Care North America |
| Member | David Feldman, PhD | National Kidney Foundation |
| KHI Board Liaison | Kevin Fowler | Voice of the Patient, Inc |
| Member | Vineeta Kumar, MD | University of Alabama-Birmingham |
| Member | Jeff Ross, PhD | Miromatrix Medical |
| Member | Robyn Shapiro, JD | Health Sciences Law Group |
| Member | Kathryn Stiede | eGenesis Bio |
| Member | Karin True, MD, FASN | University of North Carolina at Chapel Hill |
If you have any questions, please contact KHI at khi@asn-online.org