title: Selection of Patients for Initial Clinical Trials of Solid Organ Xenotransplantation.
abstract: Several groups have reported extended survival of genetically engineered pig organs in nonhuman primates, varying from almost 10 months for life-supporting kidney grafts and more than 2 years for non-life-supporting heart grafts to less than 1 month for life-supporting liver and lung grafts. We have attempted to define groups of patients who may not have an option to wait for an allograft. These include kidney, heart, and lung candidates who are highly-allosensitized. In addition, some kidney candidates (who have previously lost at least 2 allografts from rapid recurrence of native kidney disease) have a high risk of further recurrence and will not be offered a repeat allotransplant. Patients with complex congenital heart disease, who may have undergone previous palliative surgical procedures, may be unsuitable for ventricular assist device implantation. Patients dying of fulminant hepatic failure, for whom no alternative therapy is available, may be candidates for a pig liver, even if only as a bridge until an allograft becomes available. When the results of pig organ xenotransplantation in nonhuman primates suggest a realistic potential for success of a pilot clinical trial, highly selected patients should be offered participation.
authors.affiliation: 1 Thomas E. Starzl Transplantation Institute, University of Pittsburgh, Pittsburgh, PA. 2 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD. 3 Division of Transplantation Surgery, Department of Surgery, University of Maryland, Baltimore VAMC, Baltimore, MD. 4 Division of Cardiac Surgery, Department of Surgery, University of Maryland, Baltimore VAMC, Baltimore, MD.
authors.forename: David K C
authors.initials: DKC
authors.lastname: Cooper
authors.forename: Martin
authors.initials: M
authors.lastname: Wijkstrom
authors.forename: Sundaram
authors.initials: S
authors.lastname: Hariharan
authors.forename: Joshua L
authors.initials: JL
authors.lastname: Chan
authors.forename: Avneesh
authors.initials: A
authors.lastname: Singh
authors.forename: Keith
authors.initials: K
authors.lastname: Horvath
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mohiuddin
authors.forename: Arielle
authors.initials: A
authors.lastname: Cimeno
authors.forename: Rolf N
authors.initials: RN
authors.lastname: Barth
authors.forename: John C
authors.initials: JC
authors.lastname: LaMattina
authors.forename: Richard N
authors.initials: RN
authors.lastname: Pierson
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival; D064593:Heterografts; D006648:Histocompatibility; D006801:Humans; D016377:Organ Transplantation / Q000009:adverse effects / Q000941:ethics / Q000379:methods*; D018579:Patient Selection / Q000941:ethics; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D014183:Transplantation, Heterologous / Q000009:adverse effects / Q000941:ethics / Q000379:methods*; D016896:Treatment Outcome