-
1
-
-
70349597651
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework
-
Cozzi E, Tallacchini MC, Pierson RN, Sykes M, Vanderpool HY. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework. Xenotransplantation 2009 16 : 203 214.
-
(2009)
Xenotransplantation
, vol.16
, pp. 203-214
-
-
Cozzi, E.1
Tallacchini, M.C.2
Pierson, R.N.3
Sykes, M.4
Vanderpool, H.Y.5
-
2
-
-
33745844075
-
Islet xenotransplantation: Are we really ready for clinical trials?
-
Rood PPM, Cooper DKC. Islet xenotransplantation: are we really ready for clinical trials? Am J Transplant 2006 6 : 1269 1274.
-
(2006)
Am J Transplant
, vol.6
, pp. 1269-1274
-
-
Rood, P.P.M.1
Cooper, D.K.C.2
-
3
-
-
42649115431
-
A consensus document based on the pig-to-man islet transplant summit held in Stockholm, June 4-5, 2007
-
Groth CG, Korbutt GS, Hering BJ et al. A consensus document based on the pig-to-man islet transplant summit held in Stockholm, June 4-5, 2007. Xenotransplantation 2008 15 : 79.
-
(2008)
Xenotransplantation
, vol.15
, pp. 79
-
-
Groth, C.G.1
Korbutt, G.S.2
Hering, B.J.3
-
5
-
-
33644831338
-
Prolonged diabetes reversal after intraportal xenotransplantation of wild-type porcine islets in immunosuppressed nonhuman primates
-
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.
-
(2006)
Nat Med
, vol.12
, pp. 301-303
-
-
Hering, B.J.1
Wijkstrom, M.2
Graham, M.L.3
-
6
-
-
33644829825
-
Long-term survival of neonatal porcine islets in nonhuman primates by targeting costimulation pathways
-
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.
-
(2006)
Nat Med
, vol.12
, pp. 304-306
-
-
Cardona, K.1
Korbutt, G.S.2
Milas, Z.3
-
7
-
-
48249100098
-
Correction of a diabetes mellitus type 1 on primate with encapsulated islet of pig pancreatic transplant
-
Gianello P, Dufrane D. Correction of a diabetes mellitus type 1 on primate with encapsulated islet of pig pancreatic transplant. Bull Mem Acad R Med Belg 2007 162 : 439 449.
-
(2007)
Bull Mem Acad R Med Belg
, vol.162
, pp. 439-449
-
-
Gianello, P.1
Dufrane, D.2
-
8
-
-
66649102397
-
Embryonic pig pancreatic tissue for the treatment of diabetes in a nonhuman primate model
-
Hecht G, Eventov-Friedman S, Rosen C et al. Embryonic pig pancreatic tissue for the treatment of diabetes in a nonhuman primate model. Proc Natl Acad Sci U S A 2009 106 : 8659 8664.
-
(2009)
Proc Natl Acad Sci U S A
, vol.106
, pp. 8659-8664
-
-
Hecht, G.1
Eventov-Friedman, S.2
Rosen, C.3
-
9
-
-
70349597187
-
Diabetic nonhuman primates transplanted with hCD46 transgenic porcine islets maintain long-term normoglycemia under limited immunosuppression
-
in press).
-
Van Der Windt DJ, Bottino R, Casu A et al. Diabetic nonhuman primates transplanted with hCD46 transgenic porcine islets maintain long-term normoglycemia under limited immunosuppression. Am J Transplantation (in press).
-
Am J Transplantation
-
-
Van Der Windt, D.J.1
Bottino, R.2
Casu, A.3
-
10
-
-
70349586118
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 2: Source pigs
-
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.
-
(2009)
Xenotransplantation
, vol.16
, pp. 215-222
-
-
Schuurman, H.J.1
-
11
-
-
70349596353
-
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 release criteria
-
Korbutt GS. 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 release criteria. Xenotransplantation 2009 16 : 223 228.
-
(2009)
Xenotransplantation
, vol.16
, pp. 223-228
-
-
Korbutt, G.S.1
-
12
-
-
70349597644
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 4: Pre-clinical efficacy and complication data required to justify a clinical trial
-
Cooper DKC, Casu A. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 4: Pre-clinical efficacy and complication data required to justify a clinical trial. Xenotransplantation 2009 16 : 229 238.
-
(2009)
Xenotransplantation
, vol.16
, pp. 229-238
-
-
Cooper, D.K.C.1
Casu, A.2
-
13
-
-
70349587445
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 5: Strategies to prevent transmission of porcine endogenous retroviruses
-
Denner J, Schuurman HJ, Patience C. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 5: Strategies to prevent transmission of porcine endogenous retroviruses. Xenotransplantation 2009 16 : 239 248.
-
(2009)
Xenotransplantation
, vol.16
, pp. 239-248
-
-
Denner, J.1
Schuurman, H.J.2
Patience, C.3
-
14
-
-
70349584375
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 6: Patient selection for pilot clinical trials of islet xenotransplantation
-
O'Connell PJ. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 6: Patient selection for pilot clinical trials of islet xenotransplantation. Xenotransplantation 2009 16 : 249 254.
-
(2009)
Xenotransplantation
, vol.16
, pp. 249-254
-
-
O'Connell, P.J.1
-
15
-
-
70349593241
-
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 7: Informed consent and xenotransplantation clinical trials
-
Vanderpool HY. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 7: Informed consent and xenotransplantation clinical trials. Xenotransplantation 2009 16 : 255 262.
-
(2009)
Xenotransplantation
, vol.16
, pp. 255-262
-
-
Vanderpool, H.Y.1
-
16
-
-
4344669147
-
Xenotransplantation: Infectious risk revisited
-
Fishman JA, Patience C. Xenotransplantation: infectious risk revisited. Am J Transplant 2004 4 : 1383 1390.
-
(2004)
Am J Transplant
, vol.4
, pp. 1383-1390
-
-
Fishman, J.A.1
Patience, C.2
-
17
-
-
0041845122
-
Position paper of the Ethics Committee of the International Xenotransplantation Association
-
Sykes M, D'Apice A, Sandrin M. Position paper of the Ethics Committee of the International Xenotransplantation Association. Xenotransplantation 2003 10 : 194 203.
-
(2003)
Xenotransplantation
, vol.10
, pp. 194-203
-
-
Sykes, M.1
D'Apice, A.2
Sandrin, M.3
-
18
-
-
70349603405
-
-
World Health Organization. Changsha. The Changsha Communiqué Available at. (accessed on 22 July 2009).
-
World Health Organization. First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials. Changsha : The Changsha Communiqué, 2008. Available at: http://www.who.int/transplantation/xeno/ ChangshaCommunique.pdf (accessed on 22 July 2009).
-
(2008)
First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials.
-
-
-
22
-
-
0027517610
-
Regulation of somatic-cell therapy and gene therapy by the food and drug administration
-
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.
-
(1993)
N Engl J Med
, vol.329
, pp. 1169-1173
-
-
Kessler, D.A.1
Siegel, J.P.2
Noguchi, P.D.3
-
23
-
-
2642621701
-
-
Title 42, USC 262, 351. Available at. (accessed on 20 August 2009).
-
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 20 August 2009).
-
(2009)
Public Health Service Act.
-
-
-
24
-
-
0042557758
-
-
U.S. Food and Drug Administration. Title 21, U.S.C. 321. Available at. (accessed on 22 July 2009).
-
U.S. Food and Drug Administration. 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 22 July 2009).
-
(2009)
Federal Food, Drug and Cosmetic Act.
-
-
-
25
-
-
0037184808
-
Selected Food and Drug Administration review issues for regulation of allogeneic islets of Langerhans as somatic cell therapy
-
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.
-
(2002)
Transplantation
, vol.74
, pp. 1816-1820
-
-
Weber, D.J.1
McFarland, R.D.2
Irony, I.3
-
26
-
-
0003716537
-
-
U.S. Food and Drug Administration. Available at. (accessed on 22 July 2009).
-
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 22 July 2009).
-
(1998)
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy.
-
-
-
27
-
-
84960804081
-
-
U.S. Food and Drug Administration. Available at. (accessed on 22 July 2009).
-
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 22 July 2009).
-
(2008)
Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products.
-
-
-
28
-
-
70349608812
-
-
U.S. Department of Health and Human Services Secretary's Advisory Committee on Xenotransplantation. Available at. (accessed on 20 July 2009).
-
U.S. Department of Health and Human Services Secretary's Advisory Committee on Xenotransplantation. Informed Consent in Clinical Research Involving Xenotransplantation. 2004. Available at: http://www.transplantation- soc.org/downloads/SACX-informed-consent.pdf (accessed on 20 July 2009).
-
(2004)
Informed Consent in Clinical Research Involving Xenotransplantation.
-
-
|