The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 3: Pig islet product manufacturing and release testing

Xenotransplantation

Volumn 16, Issue 4, 2009, Pages 223-228

  Korbutt, Gregory S ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Islet product manufacturing; Islet product release testing; Islets of Langerhans; Type 1 diabetes; Xenotransplantation

Indexed keywords

ENDOTOXIN;

ASEPSIS; BIOSAFETY; CELL COMPOSITION; CELL COUNT; CLINICAL RESEARCH; CONSENSUS; GOOD MANUFACTURING PRACTICE; GRAM STAINING; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN RELEASE; MYCOPLASMA; NONHUMAN; OXYGEN CONSUMPTION; PANCREAS ISLET TRANSPLANTATION; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; PRODUCT PARAMETERS; QUALITY CONTROL; REVIEW; SWINE; XENOTRANSPLANTATION;

ADULT; ANIMALS; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 1; HUMANS; ISLETS OF LANGERHANS TRANSPLANTATION; MATERIALS TESTING; MICE; QUALITY CONTROL; SWINE; TISSUE AND ORGAN PROCUREMENT; TRANSPLANTATION, HETEROLOGOUS;

EID: 70349596353     PISSN: 0908665X     EISSN: 13993089     Source Type: Journal    
DOI: 10.1111/j.1399-3089.2009.00542.x     Document Type: Review

References (18)

1. U.S. Food and Drug Administration. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products. 2008. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ UCM166165.pdf (accessed on 23 July 2009).
2. Cardona K, Korbutt GS, Milas Z et al. Long-term survival of neonatal porcine islets in nonhuman primates by targeting costimulation pathways. Nat Med 2006 12 : 304 306.
3. Groth CG, Korsgren O, Tibell A et al. Transplantation of porcine fetal pancreas to diabetic patients. Lancet 1994 344 : 1402 1404.
4. Korbutt GS, Elliott JF, Ao Z et al. Large scale isolation, growth, and function of porcine neonatal islet cells. J Clin Invest 1996 97 : 2119 2129.
5. Hering BJ, Wijkstrom M, Graham ML et al. Prolonged diabetes reversal after intraportal xenotransplantation of wild-type porcine islets in immunosuppressed nonhuman primates. Nat Med 2006 12 : 301 303.
6. Schuurman HJ. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - chapter 2: source pigs. Xenotransplantation 2009 16 : 215 222.
7. U.S. Department of Agriculture. Food Security Act of 1985, Subtitle F - Animal Welfare. 1985. Available at: http://awic.nal.usda.gov/nal-display/index. php?info-center=3%20&tax-level=4&tax-subject=182&topic-id= 1118&level3-id=6735&level4-id=11095&level5-id=0&placement- default=0 (accessed on 19 August 2009).
8. Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. Available at: http://www.aaalac.org/ (accessed on 19 August 2009).
9. U.S. Food and Drug Administration. Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the use of Xenotransplantation Products in Humans. 2003. Available at: http://www.fda.gov/ BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/ Xenotransplantation/ucm074354.htm (accessed on 18 July 2009).
10. Weber DJ, McFarland RD, Irony I. Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy. Transplantation 2002 74 : 1816 1820.
11. U.S. Food and Drug Administration. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products: Notice 1993 58 FR 53248. 1993. Available at: http://www.fda.gov/downloads/ BiologicsBloodVaccines/SafetyAvailability/UCM148113.pdf (accessed on 23 July 2009).
12. Kessler DA, Siegel JP, Noguchi PD et al. Regulation of somatic-cell therapy and gene therapy by the food and drug administration. N Engl J Med 1993 329 : 1169 1173.
13. Public health service act, Title 42, USC 262, 351. 2009. Available at: http://www.kenyon.com/Resources/WaxmanHatchRH/HTMLHelp/!SSL!/WebHelp/html/ 42-U-S-C--262-Regulation-of-biological-products.htm (accessed on 23 July 2009).
14. Federal Food, Drug and Cosmetic Act, Title 21, U.S.C. 321. 2009. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/ FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm (accessed on 23 July 2009).
15. U.S. Food and Drug Administration. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. 1998. Available at: http://www.fda.gov/biologicsbloodvaccines/ guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ ucm072987.htm (accessed on 23 July 2009).
16. Shapiro AM, Lakey JR, Ryan EA et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med 2000 343 : 230 238.
17. Ichii H, Inverardi L, Pileggi A et al. A novel method for the assessment of cellular composition and beta-cell viability in human islet preparations. Am J Transplant 2005 5 : 1635 1645.
18. Papas KK, Colton CK, Nelson RA et al. Human islet oxygen consumption rate and DNA measurements predict diabetes reversal in nude mice. Am J Transplant 2007 7 : 707 713.