Role of the embryology laboratory in the human embryonic stem cell line derivation process

Cytotechnology

Volumn 52, Issue 1, 2006, Pages 1-11

  Cortés, José Luis ^a   Cobo, Fernando ^a   Barnie, Angela Helen ^a   Catalina, Purificación ^a   Cabrera, Carmen ^a   Nieto, Ana ^a   Montes, Rosa ^a   Concha, Ángel ^a  

^a HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

Author keywords

Cleanrooms; Embryology laboratory; Embryonic stem cell lines; International guidelines; IVF; Stem cell bank

Indexed keywords

CELL LINE; CELL NUCLEUS TRANSPLANTATION; CRYOPRESERVATION; EMBRYO CELL; EMBRYO RESEARCH; EMBRYOLOGY; EMBRYONIC STEM CELL; EUROPE; HUMAN; HUMAN CELL CULTURE; INFECTION CONTROL; LABORATORY; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; MEDICAL ETHICS; MEDICAL STAFF; MEDICOLEGAL ASPECT; METHODOLOGY; PRACTICE GUIDELINE; PROCESS DESIGN; REVIEW;

EID: 33847256556     PISSN: 09209069     EISSN: 15730778     Source Type: Journal    
DOI: 10.1007/s10616-006-9031-6     Document Type: Review

References (41)

1. Association of Clinical Embryologists (ACE) (2003) Accreditation Standards and Guidelines for IVF Laboratories. http://ace.ivf.net/ace/training. php
2. AGRBM (2005) Criteria for the recognition as an embryologist in human reproduction and continued professional education: the concept of the German Society for Human Reproductive Biology. Alpha 32:12-13
3. American Association of Tissue Banks (2002) Standards for tissue banking, 10th edn. American Association of Tissue Banks, McLean, VA
4. Andalucian Parliament Law 7/2003, October 20 (2003) about the regulation of the research with nonviable human embryos to "in vitro" fertilization. BOJA 210
5. Antinori S, Selman HA, Caffa B et al (1996) Zona opening of human embryos using non-contact UV laser for assisted hatching in patients with poor prognosis of pregnancy. Hum Reprod 11:2488-2492
6. American Society for Reproductive Medicine (ASRM) (2004) Reviewed guidelines for human embryology and andrology laboratories. www.asrm.org
7. Bongso A, Fong CY, Ng SC, Ratnam S (1994) Isolation and culture of inner cell mass cells from human blastocysts. Hum Reprod 9:2110-2117
8. College of American Pathologist (CAP) (2002) Laboratory Improvement. www.cap.org
9. Castilla JA, Alcaide A, Bonada M, Expósito A, Luna C, Núňez R, de los Santos MJ (eds) (2006) I. Guidelines about Human and Physical Requirements in the Assisted Reproduction Laboratory. ASEBIR Clinical Embryology Notebooks, Madrid, Spain
10. Cobo F, Stacey GN, Hunt C, Cabrera C, Nieto A, Montes R, Cortes JL, Catalina P, Barnie A, Concha A (2005) Microbiological control in stem cell banks: approaches to standarization. Appl Microbiol Biotechnol 68:456-466
11. Cobo F, Cabrera C, Catalina P, Concha A (2006a) General safety guidances in stem cell bank installations. Cytotherapy 8:47-56
12. Cobo F, Stacey GN, Cortes JL, Concha A (2006b) Enviromental monitoring in stem cell banks. Appl Microbiol Biotechnol 70:651-662
13. Cohen J, Gilligan A, Garrisi J (2004) Setting up an ART laboratory. In: Gardner DK, Weissman A, Howles CM et al (eds) Textbook of assisted reproduction techniques. Laboratory and clinical perspectives, 2nd edn. Taylor & Francis, London, UK, pp 17-24
14. Commission Directive 2006/17/EC of 8 February (2006) implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official Journal of the European Union, L 38/40
15. Cowan CA, Klimanskaya I, McMahon J, Atienza J, Witmyer J, Zucker JP, Wang S, Morton CC, McMahon AP, Powers D, Melton DA (2004) Derivation of embryonic stem-cell lines from human blastocysts. N Engl J Med 350:1353-1356
16. Department of Health (2001) A code of practice for tissue banks. Department of Health, London, UK
17. EC Guide to good Manufacturing Practice (2003) Revision to Annex 1. Manufacture of Sterile Medicinal Products. European Commission. Enterprise Directorate-General
18. European Society of Human Reproduction and Embryology (ESHRE) (2000) Guidelines for good practice in IVF laboratories. www.eshre.com
19. European Union (2004) Directive 2004/23/EC of the European Parliament and of the Council of 31 March (2004) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells. Official Journal of the European Union, L 102/48
20. FSA. The Fertility Society of Australia Reproductive Technology Accreditation Committee (RTAC) (2002) Code of practice for centres using assisted reproductive technology. www.fsa.au.com/rtac/
21. Hoffman LM, Carpenter MK (2005) Characterization and culture of human embryonic stem cells. Nat Biotechnol 23:699-708
22. ICMR-DBT. Indian Council of Medical Research (2006) Guidelines for stem cell research and therapy. www.icmr.nic.in
23. ISO (1999) International Standard ISO 14644. Cleanrooms and associated controlled environments. Part 1: Classification of air cleanliness. International Organization for Standarization, Geneve, Switzerland
24. ISO (2000) International Standard ISO 9001. Quality Management Systems-Requeriments. International Organization for Standarization, Geneve, Switzerland
25. ISO (2005) International Standard ISO 17025. General requirements for the competence of testing and calibration laboratories. International Organization for Standarization, Geneve, Switzerland
26. Kim HS, Oh SK, Park YB, Ahn HJ, Sung KC, Kang MJ, Lee LA, Suh CS, Kim SH, Kim DW, Moon SY (2005) Methods for derivation of human embryonic stem cells. Stem Cells 23:1228-1233
27. Ludwig TE, Levenstein ME, Jones JM, Berggren WT, Mitchen ER, Frane JL, Crandall LJ, Daigh CA, Conard KR, Piekarczyk MS, Llanas RA, Thomson JA (2006) Derivation of human embryonic stem cells in defined conditions. Nat Biotechnol 24:185-187
28. Mortimer D (2005) A critical assessment of the impact of the European Union Tissues and Cells Directive (2004) on laboratory practices in assisted conception. Reprod Biomed Online 11:162-176
29. National Academy of Medical Sciences of India (NAMSI) (2005) National Guidelines for accreditation, supervision and regulation of ART clinics in India. www.icmr.nic.in
30. National Academies Press (NAP) (2005) Guidelines for Human Stem Cell Research. www.nap.edu/books
31. National Institute of Health (NIH) (2002) Guidance for investigators and institutional review boards regarding research involving human embryonic stem cells, germ cells, and stem cell-derived test articles
32. Noda Y, Goto Y, Umaoka Y et al (1994) Culture of human embryos in alpha modification of Eaglés medium under low oxygen tension and low illumination. Fertil Steril 62:1022-1027
33. Pharmaceutical Inspection Co-operation Scheme (2002) Recommendation on sterility testing. Pharmaceutical Inspection Convention, PI 012-1, November 1, 2002
34. Reubinoff BE, Pera MF, Fong CY, Trounson A, Bongso A (2000) Embryonic stem cell lines from human blastocysts: somatic differentiation in vitro. Nat Biotechnol 18:399-404
35. Richards M, Tan S, Fong CY, Biswas A, Chan WK, Bongso A (2003) Comparative evaluation of various human feeders for prolongued undifferentiated growth of human embryonic stem cells. Stem Cells 21:546-556
36. Sharp J (2005) GMP and quality assurance in sterile products manufacture. In: J Sharp (ed) Good pharmaceutical manufacturing practice. CRC Press, Florida, USA, pp 371-404
37. Solter D, Knowles BB (1975) Immunosurgery of mouse blastocysts. Proc Natl Acad Sci USA 72:5099-5102
38. Spanish Law 14/2006, May 26th, about Assisted Reproduction Techniques 2006. BOE 126
39. Spanish Royal Decree 21322004, about the requirements and procedures to request the development of research projects with human embryonic stem cells. 2004. BOE 262
40. Tanaka N, Takeuchi T, Neri QV, Sills ES, Palermo GD (2006) Laser-assisted blastocyst dissection and subsequent cultivation of embryonic stem cells in a serum/cell free culture system: applications and preliminary results in a murine model. J Transl Med 8(4):20 DOI 10.1186/1479-5876-4-20
41. Xu C, Inokuma MS, Denham J, Golds K, Kundu P, Gold JD, Carpenter MK (2001) Feeder-free growth of undifferentiated human embryonic stem cells. Nat Biotechnol 19:971-974