KHI Current Project

Xenotransplantation: Knowledge and Perception Assessment


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.


Key concepts that convey xenotransplantation first-in-human trials for sponsors, including toolkits for effective communications with key stakeholder groups.


First phase completion goal: 1Q2022

Workgroup Members

Steering CommitteeMelanie Blank, MD US Food and Drug Administration
Steering CommitteeKaren Jackler, MPHUS Food and Drug Administration
Steering CommitteeAnne Rowzee, PhDUS Food and Drug Administration
MemberMary BalikerPatient Advocate
MemberVanessa EvansFresenius Medical Care North America
MemberDavid Feldman, PhDNational Kidney Foundation
KHI Board LiaisonKevin FowlerVoice of the Patient, Inc
MemberVineeta Kumar, MDUniversity of Alabama-Birmingham
MemberJeff Ross, PhDMiromatrix Medical
MemberRobyn Shapiro, JDHealth Sciences Law Group
MemberKathryn StiedeeGenesis Bio
MemberKarin True, MD, FASNUniversity of North Carolina at Chapel Hill

If you have any questions, please contact KHI at