Theriogenology
Volume 67, Issue 1 , Pages 198-206 , 1 January 2007

The US FDA and animal cloning: Risk and regulatory approach

References 

  1. Wilmut I, Schnieke AE, McWhir J, Kind AJ, Campbell KH. Viable offspring derived from fetal and adult mammalian cells. Nature. 1997;385:810
  2. http://www.fda.gov/cvm/CVM_Updates/clones.htm, 2005
  3. National Research Council . Animal biotechnology: science-based concerns. Washington, DC: National Academies Press; 2002;
  4. http://www.fda.gov/cvm/VMAC/VMACFall2003.htm, 2005
  5. Prather RS, Barnes FL, Sims MM, Robl JM, Eyestone WH, First NL. Transgenic swine for biomedicine and agriculture. Biol Reprod. 1987;37:859
  6. Cibelli JB, Stice SL, Golueke PJ, Kane JJ, Jerry J, Blackwell C, et al. Cloned transgenic calves produced from nonquiescent fetal fibroblasts. Science. 1998;280:1256
  7. Jones PA, Takai D. The role of DNA methylation in mammalian epigenetics. Science. 2001;293:1068
  8. Jaenisch R, Bird A. Epigenetic regulation of gene expression: how the genome integrates intrinsic and environmental signals. Nat Genet. 2003;33(Suppl):245
  9. Cezar GG. Epigenetic reprogramming of cloned animals. Cloning Stem Cells. 2003;5:165
  10. Bourc’his D, Le Bourhis D, Patin D, Niveleau A, Comizzoli P, Renard JP, et al. Delayed and incomplete reprogramming of chromosome methylation patterns in bovine cloned embryos. Curr Biol. 2001;11:1542
  11. Dean W, Santos F, Stojkovic M, Zakhartchenko V, Walter J, Wolf E, et al. Conservation of methylation reprogramming in mammalian development: aberrant reprogramming in cloned embryos. Proc Natl Acad Sci USA. 2001;98:13734
  12. Kang YK, Koo DB, Park JS, Choi YH, Lee KK, Han YM. Influence of oocyte nuclei on demethylation of donor genome in cloned bovine embryos. FEBS Lett. 2001;499:55
  13. Kang YK, Koo DB, Park JS, Choi YH, Chung AS, Lee KK, et al. Aberrant methylation of donor genome in cloned bovine embryos. Nat Genet. 2001;28:173
  14. Kang YK, Park JS, Doo DB, Choi YH, Kim SUK, Lee KK, et al. Limited demethylation leaves mosaic-type methylation states in cloned bovine pre-implantation embryos. EMBO J. 2002;21:1092
  15. Ohgane J, Wakayama T, Kogo Y, Senda S, Hattori N, Tanaka S, et al. DNA methylation variation in cloned mice. Genesis. 2001;30:45
  16. Wilmut I. Are there any normal cloned mammals?. Nat Med. 2002;8:215
  17. Santos F, Zakhartchenko V, Stojkovic M, Peters A, Jenuwein T, Wolf E, et al. Epigenetic marking correlates with developmental potential in cloned bovine preimplantation embryos. Curr Biol. 2003;13:1116
  18. Shi W, Zakhartchenko V, Wolf E. Epigenetic reprogramming in mammalian nuclear transfer. Biol Reprod. 2004;71:340
  19. Chen T, Jiang Y, Zhang YL, Liu JH, Hou Y, Schatten H, et al. DNA hypomethylation of individual sequences in aborted cloned bovine fetuses. Front Biosci. 2005;10:3002
  20. Yamazaki Y, Low EW, Marikawa Y, Iwahashi K, Bartolomei MS, McCarrey JR, et al. Reprogramming of primordial germ cells begins before migration into the genital ridge, making these cells inadequate donors for reproductive cloning. Proc Natl Acad Sci USA. 2003;100:12207
  21. Chavatte-Palmer P, Heyman Y, Richard C, Monget P, LeBourhis D, Kann G, et al. Clinical, hormonal, and hematologic characteristics of bovine calves derived from nuclei from somatic cells. Biol Reprod. 2002;66:1596
  22. Tamashiro KL, Wakayama T, Akutsu H, Yamazaki Y, Lachey JL, Wortman MD, et al. Cloned mice have an obese phenotype not transmitted to their offspring. Nat Med. 2002;8:262
  23. ViaGen (in the Draft Risk Assessment on Animal Cloning); 2005.
  24. Rudenko L, Matheson J, Adams AL, Dubbin ES, Greenlees KJ. Food consumption risks associated with animal clones: what should be investigated?. Cloning Stem Cells. 2004;6:79
  25. http://www.fda.gov/cvm/cloning.htm, 2006
  26. Cyagra (in the Draft Risk Assessment on Animal Cloning); 2004.
  27. Sinclair KD, McEvoy TG, Maxfield EK, Maltin CA, Young LE, Wilmut I, et al. Aberrant fetal growth and development after in vitro culture of sheep zygotes. J Reprod Fertil. 1999;116:177
  28. Farin PW, Crosier AE, Farin CE. Influence of in vitro systems on embryo survival and fetal development in cattle. Theriogenology. 2001;55:151
  29. Matsuzaki M, Shiga K, Shiga K. Endocrine characteristics of cloned calves. Cloning Stem Cells. 2002;4:261
  30. Batchelder C. Cloning in cattle: effect of the nuclear-donor cell on cloning efficiency, perinatal physiology, and long-term health of cloned calves. Cloning Stem Cells. 2005;7:238
  31. Gibbons J, Arat S, Rzucidlo J, Miyoshi K, Waltenburg R, Respess D, et al. Enhanced survivability of cloned calves derived from roscovitine-treated adult somatic cells. Biol Reprod. 2002;66:895
  32. Gong G, Dai Y, Zhu H, Wang H, Wang L, Li R, et al. Generation of cloned calves from different types of somatic cells. Sci China C: Life Sci. 2004;47:470
  33. Heyman Y, Richard C, Rodriguez-Martinez H, Lazzari G, Chavatte-Palmer P, Vignon X, et al. Zootechnical performance of cloned cattle and offspring: preliminary results. Cloning Stem Cells. 2004;6:111
  34. Behboodi E, Anderson GB, BonDurant RH, Cargill SL, Kreuscher BR, Medrano JF, et al. Birth of large calves that developed from in-vitro derived bovine embryos. Theriogenology. 1995;44:227
  35. Farin PW, Farin CE. Transfer of bovine embryos produced in vivo or in vitro: survival and fetal development. Biol Reprod. 1995;52:676
  36. Hasler JF, Henderson WB, Hurtgen PJ, Jin ZQ, McCauley AD, Mower SA, et al. Production, freezing and transfer of bovine IVF embryos and subsequent calving results. Theriogenology. 1995;43:141
  37. Kruip T, den Daas JHG, den Daas JHG. In vitro produced and cloned embryos: effects on pregnancy, parturition and offspring. Theriogenology. 1997;47:43
  38. Keefer CL, Baldassarre H, Keyston R, Wang B, Bhatia B, Bilodeau AS, et al. Generation of dwarf goat (Capra hircus) clones following nuclear transfer with transfected and nontransfected fetal fibroblasts and in vitro-matured oocytes. Biol Reprod. 2001;64:849
  39. Gauthier M, Pierson J, Drolet M, Bhatia B, Baldassarre H, Keefer CL. Sexual maturation and fertility of male Nigerian Dwarf goat (Capra hircus) clones produced by somatic cell nuclear transfer. Cloning Stem Cells. 2001;3:151
  40. Keefer CL, Keyston R, Lazaris A, Bhatia B, Begin I, Bilodeau AS, et al. Production of cloned goats after nuclear transfer using adult somatic cells. Biol Reprod. 2002;66:199
  41. Polejaeva IA, Chen SH, Vaught TD, Page RL, Mullins J, Ball S, et al. Cloned pigs produced by nuclear transfer from adult somatic cells. Nature. 2000;407:86
  42. Walker SC, Shin T, Zaunbrecher GM, Romano JE, Johnson GA, Bazer FW, et al. A highly efficient method for porcine cloning by nuclear transfer using in vitro-matured oocytes. Cloning Stem Cells. 2002;4:105
  43. Boquest AC, Grupen CG, Harrison SJ, McIlfatrick SM, Ashman RJ, d’Apice AJF, et al. Production of cloned pigs from cultured fetal fibroblast cells. Biol Reprod. 2002;66:1283
  44. Eggan K, Akutsu H, Loring J, Jackson-Grusby L, Klemm M, Rideout WM, et al. Hybrid vigor, fetal overgrowth, and viability of mice derived by nuclear cloning and tetraploid embryo complementation. Proc Natl Acad Sci USA. 2001;98:6209
  45. Sakai RR, Tamashiro KL, Yamazaki Y, Yanagimachi R. Cloning and assisted reproductive techniques: influence on early development and adult phenotype. Birth Defects Res C: Embryo Today. 2005;75:151
  46. Cyagra (in the Draft Risk Assessment on Animal Cloning); 2002.
  47. Garry FB, Adams R, McCann JP, Odde KG. Postnatal characteristics of calves produced by nuclear transfer cloning. Theriogenology. 1996;45:141
  48. Hill JR, Roussel AJ, Cibelli JB, Edwards JF, Hooper NL, Miller MW, et al. Clinical and pathologic features of cloned transgenic calves and fetuses (13 case studies). Theriogenology. 1999;51:1451
  49. Kato Y, Tani T, Tsunoda Y. Cloning of calves from various somatic cell types of male and female adult, newborn and fetal cows. J Reprod Fertil. 2000;120:231
  50. Kubota C, Yamakuchi H, Todoroki J, Mizoshita K, Tabara N, Barber M, et al. Six cloned calves produced from adult fibroblast cells after long-term culture. Proc Natl Acad Sci USA. 2000;97:990
  51. Lanza RP, Cibelli JB, Faber D, Sweeney RW, Henderson B, Nevala W, et al. Cloned cattle can be healthy and normal. Science. 2001;294:1893
  52. Miyashita N, Tomii R, Kurome M, Ueda H, Hirakawa K, Ueno S, et al. Evaluation of the quality of porcine somatic cell nuclear transfer embryo by gene transcription profiles. Biol Reprod. 2002;66:1649
  53. Pace MM, Augenstein ML, Betthauser JM, Childs LA, Eilertsen KJ, Enos JM, et al. Ontogeny of cloned cattle to lactation. Biol Reprod. 2002;67:334
  54. Walker SK, Hartwich KM, Seamark RF. The production of unusually large offspring following embryo manipulation: concepts and challenges. Theriogenology. 1996;45:111
  55. Young LE, Sinclair KD, Wilmut I. Large offspring syndrome in cattle and sheep. Rev Reprod. 1998;3:155
  56. Chavatte-Palmer P, Remy D, Cordonnier N, Richard C, Issenman H, Laigre P, et al. Health status of cloned cattle at different ages. Cloning Stem Cells. 2004;6:94
  57. Park MR, Cho SK, Lee SY, Choi YJ, Park JY, Kwon DN, et al. A rare and often unrecognized cerebromeningitis and hemodynamic disorder: a major cause of sudden death in somatic cell cloned piglets. Proteomics. 2005;5:1928
  58. Wrenzycki C, Herrmann D, Lucas-Hahn A, Korsawe K, Lemme E, Niemann H. Messenger RNA expression patterns in bovine embryos derived from in vitro procedures and their implications for development. Reprod Fertil Dev. 2005;17:23
  59. Lee RS, Peterson AJ, Donnison MJ, Ravelich S, Ledgard AM, Li N, et al. Cloned cattle fetuses with the same nuclear genetics are more variable than contemporary half-siblings resulting from artificial insemination and exhibit fetal and placental growth deregulation even in the first trimester. Biol Reprod. 2004;70:1
  60. Hill JR, Winger QA, Long CR, Looney CR, Thompson JA, Westhusin ME. Development rates of male bovine nuclear transfer embryos derived from adult and fetal cells. Biol Reprod. 2000;63:1787
  61. Kishi M, Itagaki Y, Takakura R, Imamura M, Sudo T, Yoshinari M, et al. Nuclear transfer in cattle using colostrum-derived mammary gland epithelial cells and ear-derived fibroblast cells. Theriogenology. 2000;54:675
  62. Wells DN, Forsyth JT, McMillan V, Oback B. The health of somatic cell cloned cattle and their offspring. Cloning Stem Cells. 2004;6:101
  63. Renard JP, Chastant S, Chesne P, Richard C, Marchal J, Cordonnier N, et al. Lymphoid hypoplasia and somatic cloning. Lancet. 1999;53:1489
  64. Merck Veterinary Manual, 9th ed., 2005.
  65. Jones T, Hunt RD. Veterinary pathology. 4th ed.. Philadelphia: Lea & Febiger; 1983;p. 1070–1071
  66. Straw B. Diseases of swine. 8th ed.. Iowa State University Press; 1999;
  67. Forsberg EJ, Strelchenko NS, Augenstein ML, Betthauser JM, Childs LA, Eilertsen KJ, et al. Production of cloned cattle from in vitro systems. Biol Reprod. 2002;67:327
  68. Galli C, Lagutina I, Crotti G, Colleoni S, Turini P, Ponderato N, et al. Pregnancy: a cloned horse born to its dam twin. Theriogenology. 2003;59:599
  69. Tian XC, Kubota C, Sakashita K, Izaike Y, Okano R, Tabara N, et al. Meat and milk compositions of bovine clones. Proc Natl Acad Sci USA. 2005;102:6261
  70. Archer GS, Dindot S, Friend TH, Walker S, Zaunbrecher G, Lawhorn B, et al. Hierarchical phenotypic and epigenetic variation in cloned swine. Biol Reprod. 2003;69:430
  71. Savage AF, Maull J, Tian XC, Taneja M, Katz L, Darre M, et al. Behavioral observations of adolescent Holstein heifers cloned from adult somatic cells. Theriogenology. 2003;60:1097
  72. Archer GS, Friend TH, Piedrahita J, Nevill CH, Walker S. Behavioral variation among cloned pigs. Appl Anim Behav Sci. 2003;82:151
  73. Tamashiro KL, Wakayama T, Blanchard RJ, Blanchard DC, Yanagimachi R. Postnatal growth and behavioral development of mice cloned from adult cumulus cells. Biol Reprod. 2000;63:328
  74. Yonai M, Kaneyama K, Miyashita N, Kobayashi S, Goto Y, Bettpu T, et al. Growth, reproduction, and lactation in somatic cell cloned cows with short telomeres. J Dairy Sci. 2005;88:4097
  75. Japan Livestock Technology Association, Project report of an investigation on the properties of products from cloned cattle: an urgent study project for the utilization of cloned cattle, Japan Livestock Technology Association; 2005.
  76. Aoki S, Takahashi R, Nisisouzu T, Kitamura S, Dochi O, Kishi M, et al. A comparative investigation of the characteristics of Holstein cows cloned from colostrum-derived mammary grand epithelial cells in an automatic milking system. Theriogenology. 2003;59:234
  77. Walsh MK, Lucey JA, Govindasamy-Lucey S, Pace MM, Bishop MD. Comparison of milk produced by cows cloned by nuclear transfer with milk from non-cloned cows. Cloning Stem Cells. 2003;5:213
  78. Wells DN, Forsyth JT, McMillan V, Oback B. The health of somatic cell cloned cattle and their offspring. Cloning Stem Cells. 2004;6:101
  79. Wells DN. Animal cloning: problems and prospects. Rev Sci Tech. 2005;24:251
  80. IFIC Survey: Food Biotechnology Not A Top-Of-Mind Concern for American Consumers, International Food Information Council; 2005.
  81. Public Sentiment about Genetically Modified Food, Pew Initiative on Food and Biotechnology; 2005.

PII: S0093-691X(06)00527-9

doi: 10.1016/j.theriogenology.2006.09.033

Theriogenology
Volume 67, Issue 1 , Pages 198-206 , 1 January 2007

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