Project Grant R01TR003844
- Grant Award Summary The National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), awarded The Johns Hopkins University a $1,031,754 Project Grant on September 2, 2025, for a five-year performance period concluding August 31, 2030. The award supports preclinical and translational research to advance kidney xenotransplantation (KXTX)—the transplantation of genetically modified pig organs into nonhuman primates and...
- Summary Oregon Health & Science University (OHSU) received a $1,329,538 Project Grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), effective July 1, 2025, with a completion date of April 30, 2030. The project focuses on developing genetically enhanced allogeneic hepatocytes for transplantation without requiring immunosuppression. OHSU will conduct three...
- Summary of Federal Cooperative Agreement Award New York University School of Medicine received a $2.86M Cooperative Agreement from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), effective July 1, 2025 through May 31, 2030. The award funds research applying genomics and omics (multi-omic analyses) to advance pig-to-human xenotransplantation outcomes. The primary deliverables include development of...
- Federal Project Grant Award Summary Renovate Biosciences Inc. received a $584,232 Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), effective September 25, 2025, with completion targeted for August 31, 2026. The award supports the BLIPS (Biocompatible Liver in Pigs) project, which aims to develop xenotransplantation technology using pigs as...
- This Project Grant award from the National Science Foundation's Engineering program (CFDA 47.041) provides $1,800,000 to Missouri University of Science & Technology to develop an artificial intelligence decision support system for kidney transplant healthcare. The goal is to reduce kidney discard rates by at least 10% by embedding preferences and fairness considerations into AI models used to match donor kidneys with transplant centers. Two subawards totaling $XXX,XXX are provided to Saint...
- Federal Grant Award Summary Duke University's Office of Research Administration received a $444,125 Project Grant from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), effective August 1, 2025 through July 31, 2027. The award supports investigator-initiated research focused on addressing early xenograft rejection in xenotransplantation—specifically, the simultaneous targeting of immunoglobulin G (IgG)...
- This $667,697 Project Grant awarded March 1, 2025, by the National Institute of Biomedical Imaging and Bioengineering under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286) supports research to identify and disseminate bioethical concerns related to bionic and robotic prostheses development and clinical translation. The University of North Texas Health Science Center at Fort Worth will conduct a two-year study (through February 28,...
- Federal Project Grant Summary New York University School of Medicine received a $762,747 Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837), effective August 22, 2025 through May 31, 2030. The grant funds research to develop engagement protocols for donor family members and healthcare staff involved in research studies utilizing recently deceased humans maintained physiologically following declaration of...
- Summary Johns Hopkins University's Institute for Clinical and Translational Research (ICTR) received $1,095,342 in funding from the National Center for Advancing Translational Sciences (NCATS) under CFDA 93.350, awarded September 15, 2025, with performance extending through August 31, 2030. This postdoctoral training grant (T32) delivers an integrated set of training opportunities designed to develop the next generation of clinical and translational science researchers. The program provides core...
- The National Institutes of Health National Institute of Allergy and Infectious Diseases awarded a $1,074,434.37 Project Grant to the Massachusetts General Hospital under the Allergy and Infectious Diseases Research program (CFDA 93.855) on March 17, 2021 with a completion date of July 12, 2021. The grant funding supports research to develop protocols to induce tolerance in non-human primate heart allograft recipients without chronic immunosuppression. The awardee will test approaches to either...
INFORMING ETHICAL TRANSLATION OF XENOTRANSPLANTATION CLINICAL TRIALS - PROJECT SUMMARY XENOTRANSPLANTATION (XTX) IS A NOVEL EXPERIMENTAL TREATMENT THAT INVOLVES TRANSPLANTING ORGANS FROM NONHUMAN ANIMALS INTO HUMANS. DUE TO THE SCARCITY OF HUMAN ORGANS FOR TRANSPLANTATION, XTX COULD HELP ALLEVIATE THE ORGAN SHORTAGE, WHICH IS AN ONGOING PUBLIC HEALTH PROBLEM. EARLY EXPERIMENTAL XENOTRANSPLANTS WERE PERFORMED IN THE U.S. FROM THE 1960S TO 1990S, INVOLVING A CHIMPANZEE KIDNEY, A BABOON HEART, AND A BABOON LIVER. DESPITE HOLDING GREAT PROMISE, XTX EXPERIMENTS ENDED IN THE LATE 1990S DUE TO SCIENTIFIC AND ETHICAL CHALLENGES. TODAY, XTX IS UNDERGOING A RENAISSANCE. SCIENTIFIC ADVANCES IN IMMUNOSUPPRESSION AND GENOME EDITING TECHNIQUES HAVE MITIGATED THE RISK OF ZOONOTIC DISEASE TRANSMISSION. THE TRANSPLANT FIELD IS PRIMED TO CONDUCT XTX CLINICAL TRIALS AND THEN TRANSLATE FINDINGS TO CLINICAL CARE. HOWEVER, AVAILABLE GUIDELINES FOR CONDUCTING XTX CLINICAL TRIALS ARE OUTDATED, DO NOT ADDRESS ADVANCES IN THE SCIENCE OF XTX, DO NOT ACCOUNT FOR STAKEHOLDERS' CONCERNS, AND DO NOT CONSIDER THE IMPACT ON POLICY CHANGES TO ORGAN ALLOCATION. THE OVERALL OBJECTIVE OF THE PROPOSED STUDY IS TO IDENTIFY APPROPRIATE ETHICAL AND POLICY GUIDANCE FOR TRANSLATIONAL SOLID ORGAN XTX CLINICAL TRIALS. THE RESEARCH TEAM INCLUDES NATIONAL BIOETHICS LEADERS AT THE HASTINGS CENTER, NORTHWESTERN UNIVERSITY, AND RUTGERS UNIVERSITY, WITH THE HASTINGS CENTER SERVING AS THE DATA COORDINATING CENTER. WE WILL CONDUCT IN-DEPTH INTERVIEWS WITH TRANSPLANT PATIENTS, TRANSPLANT CLINICIANS, TRANSPLANT REGULATORS, AND HUMAN SUBJECTS ETHICS REGULATORS, AND OBTAIN INPUT FROM AN ETHICS AND POLICY ADVISORY COMMITTEE COMPRISED OF EXPERTS IN TRANSLATIONAL SCIENCE AND BIOETHICS TO: (1) ASSESS XTX STAKEHOLDERS' PERCEPTIONS AND CONCERNS ABOUT ETHICAL AND POLICY CHALLENGES FOR XTX CLINICAL TRIALS; (2) DEVELOP XTX STAKEHOLDER DECISION AIDS THAT HELP PATIENTS, CLINICIANS, AND INSTITUTIONAL REVIEW BOARDS TO EVALUATE, DESIGN, AND OVERSEE XTX CLINICAL TRIALS, RESPECTIVELY; AND (3) DEVELOP RECOMMENDATIONS FOR THE ETHICAL TRANSLATION OF XTX CLINICAL TRIALS. UPDATED GUIDANCE AND DECISION AIDS WILL FACILITATE ETHICAL DECISION-MAKING ABOUT XTX CLINICAL TRIALS. THE INNOVATIVE AND TIMELY DECISION AIDS WILL CONTAIN GENERALIZABLE ETHICAL PRINCIPLES FOR HUMAN SUBJECTS RESEARCH PROTECTIONS AND POLICY CONSIDERATIONS REGARDING ORGAN ALLOCATION THAT WILL APPLY TO XTX CLINICAL TRIALS INVOLVING OTHER ORGANS. FUTURE NEXT STEPS INCLUDE DESIGNING A STUDY TO TEST THE INFLUENCE OF THE DECISION AIDS ON THE CHOICES OF PATIENTS, IRBS, AND TRANSPLANT CENTERS ABOUT XTX KIDNEY CLINICAL TRIALS.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | ($74k) | 12/12/25 | ||
| Not listed | $458.2k | 8/8/24 | ||
| Not listed | $468.2k | 7/28/23 | ||
| Not listed | $0 | 8/16/22 | ||
| Not listed | $0 | 8/16/22 |