Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting, May 14, 2009

 

Bibliography

 

Topic II:  Animal Models for Porcine Xenotransplantation Products Intended to Treat   

Type 1 Diabetes or Acute Liver Failure

 

Yang, Y-G and Sykes, M. (2007)  Xenotransplantation:  current status and a perspective on the future.  Nature Reviews/Immunology, 7, 519-531.

 

Flendrig, L.M., Chamuleau, R.A.F.M., Maas, M.A.W., Daalhuisen, J., Hasset, B., Kilty, C.G., et al. (1999) Evaluation of a novel bioartificial liver in rats with complete liver ischemia: treatment efficacy and species-specific α-GST detection to monitor hepatocyte viability.  J Hepat, 30, 311-320.

 

Fruhauf, N.R., Oldhafer, K.J., Joltje, M., Kaiser, G.M., Fruhauf, J-H, Stavrou, G.A., et al. (2004)  A bioartificial liver support system using primary hepatocytes: A preclinical study in a new porcine hepatectomy model. Surgery, 136, 47-56.

 

Gazda, L.S., Vinerean, H.V., Laramore, M.A., Diehl, C.H., Hall, R.D., Rubin, A.L. and Smith, B.H. (2007) Encapsulation of porcine islets permits extended culture time and insulin independence in spontaneously diabetic BB rats. Cell Transplantation, 16, 609-620.

 

Guidance for Industry: Source animal, product, preclinical and clinical issues concerning the use of xenotransplantation products in humans.  FDA, April 2003.  http://www.fda.gov/cber/guidelines.htm.

 

Guidance for Industry: Public health issues posed by the use of nonhuman primate xenografts in humans.  FDA, April 1999.  http://www.fda.gov/cber/guidelines.htm.

 

Guidance for Industry: Precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their contacts. FDA, Dec. 1999.  http://www.fda.gov/cber/guidelines.htm.

 

Guidance for Industry: Precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their intimate contacts.  FDA, Feb. 2002. http://www.fda.gov/cber/guidelines.htm.

 

Gill, R.Q. and Sterling, R.K. (2001) Acute liver failure. J Clin. Gastroenterol, 33(3), 191-198.

 

Goto, M., Groth, C.G., Nilsson, B., Korsgren, O. (2004) Intraportal pig islet xenotransplantation into athymic mice as an in vivo model for the study of the instant blood-mediated inflammatory reaction. Xenotransplantation, 11, 195-202.

 

Inverardi, L., Kenyon, N.S. and Ricordi, C. (2003) Islet transplantation: immunological perspectives. Current Opinion in Immunology, 15, 507-511.

 

Abouna, G.M., Ganguly, P.K., Hamdy, H.M., Jabur, S.S., Tween. W.A. and Costa, G. (1999) Extracorporeal liver perfusion system for successful hepatic support pending liver regeneration or liver transplantation: A pre-clinical controlled trial. Transplantation, 67(12), 1576-1583.

 

Iwata, H and Ueda, Y. (2004) Pharmacokinetic considerations in development of a bioartificial liver. Clin Pharmacokinet, 43(4), 211-225.

 

Kahl, S, Malfertheiner, P. (2004) Exocrine and endocrine pancreatic insufficiency after pancreatic surgery. Best Practice & Research Clinical Gastroenterology, 18(5), 947-955.

 

King, M., Pearson, T., Rossini, A.A., Shultz, L.D. and Greiner, D.L. (2008) Humanized mice for the study of type 1 diabetes and beta cell function. Immunology of Diabetes V. Ann NY Acad. Sci., 1150, 46-53.

 

Kobayashi, T., Arefanian, H., Harb, G., Tredge, E.G., Rajott, R.V., Korbutt, G.S. and Rayat, G.R. (2008) Prolonged survival of microencapsulated neonatal porcine islet xenografts in immune-competent mice without antirejection therapy. Cell Transplantation, 17, 1243-1256.

 

Lenzen, S. (2008) The mechanisms of alloxan- and streptozotocin-induced diabetes. Diabetologia, 51, 216-226l.

 

MacKenzie, D.A., Hullet, D.A. and Sollinger, H.W. (2008) Xenogeneic transplantation of porcine islets: An overview. Transplantation, 76(6), 887-891.

 

PHS Guideline on infectious disease issues in xenotransplantation. PHS, January 19, 2001.

 

Pryor, E.I., II, Vacanti, J.P. (2008) The promise of artificial liver replacement. Frontiers in Bioscience, 13, 2140-2159.

 

Rees, D.A. and Alcolado, J.C. (2004) Animal models of diabetes mellitus.  Diabetic Medicine, 22, 359-370.

 

Safley, S.A., Kapp, J.A. and Weber, C.J. (2002)  Proliferative and cytokine responses in CTLA4-Ig-treated diabetic NOD mice transplanted with microencapsulated neonatal porcine ICCs. Cell Transplantation, 11, 695-705.

 

Albrecht, J, Jones E. A. (1999) Hepatic encephalopathy: molecular mechanisms underlying the clinical syndrome. J Neurol Sci, 170, 138-146.

 

Skawran, S., Palmes, D., Budny, T, Bahde, R, Stratmann, U. and Spiegel. H.U. (2003) Development and evaluation of an experimental model for investigating the pathogenesis and therapeutic strategies of acute liver failure. Transplantation Proceedings, 35, 3142-3146.

 

Sumi, S. and Tamura, K. (2000) Frontiers of pancreas regeneration. J Hepatobiliary Pancreat Surg 7, 286-294.

 

Van de Kerkhove, M.P., Hoekstra, R., Chamuleau, R.A.F.M. and van Gulik, T.M. (2004) Clinical application of bioartificial liver support systems. Annals of Surgery, 240(2),  216-230.

 

Wang, Z. and Gleichmann, H. (1998) Crucial target molecule in diabetes induced with multiple low doses of streptozotocin in mice. Diabetes, 47, 50-56.

 

Wennberg, L., Sundberg, B., Ekdahl-Nilsson, K. and Korsgren, O. (2001) C-peptide determinations in islet xenotransplantation: a study in the pig-to-mouse model. Cell Transplantation, 10, 165-173.

 

Xu, B.Y., Al-Abdullah, I.H., Kandeel, F., Hering, B. and Wright, J.R., Jr. (2008) Long-term survival and function of intraportal porcine and human islet xenografts in nondiabetic nude mice. Transplantation Proceedings, 40, 584-586.

 

Guidance for Industry: Regulation of genetically engineered animals containing heritable recombinant DNA constructs. FDA, January 15, 2009. http://www.fda.gov/cvm.

 

Allen, J.A., Hassanein, T. and Bhatia, S.N. (2001) Advances in bioartificial liver devices. Hepatololgy, 34(3), 447-454.

 

Arefanian, H, Tredget, E.B., Rajotte, R.V., Korbutt, G.S., Gill, R.G. and Rayat, G.R. (2007) Combination of anti-CD4 with anti-LFA-1 and anti-DC154 monoclonal antibodies promotes long-term survival and function of neonatal porcine islet xenografts in spontaneously diabetic NOD mice. Cell Transplantation, 16, 787-798.

 

Belanger, M. and Butterworth, R.F. (2005) Acute liver failure: a critical appraisal of available animal models. Metabolic Brain Disease, 20(4), 409-421.

 

Bottino, R. and Cooper, D.K. (2008) Islet xenotransplantation: the pig-to-non-human primate model. Xenotransplantation, 15, 104-106.

 

Dehoux, J-P., Gianello, P. (2007) The importance of large animal models in transplantation. Frontiers in Bioscience, 12, 4864-4880.

 

Dufrane, D. and Gianello, P. (2008) Pig islet xenotransplantation into non-human primate model. Transplantation, 86, 753-760.