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Volumn 43, Issue 6, 2011, Pages 627-634

Regulation of cellular therapy in Australia

Author keywords

Accreditation; Biologicals regulation; Cell therapy; GMP

Indexed keywords


EID: 83055163841     PISSN: 00313025     EISSN: 14653931     Source Type: Journal    
DOI: 10.1097/PAT.0b013e32834b3cfa     Document Type: Article
Times cited : (19)

References (37)
  • 1
    • 79959215607 scopus 로고    scopus 로고
    • Australia
    • Scott C. Australia. Bio Process Int 2011; 9 (S6): 4-7.
    • (2011) Bio Process Int , vol.9 , Issue.S6 , pp. 4-7
    • Scott, C.1
  • 5
    • 61449229156 scopus 로고    scopus 로고
    • The EBMT activity survey 2007 with focus on allogeneic HSCT for AML and novel cellular therapies
    • Gratwohl A, Baldomero H, Schwendener A, et al. The EBMT activity survey 2007 with focus on allogeneic HSCT for AML and novel cellular therapies. Bone Marrow Transplant 2009; 43: 275-91.
    • (2009) Bone Marrow Transplant , vol.43 , pp. 275-291
    • Gratwohl, A.1    Baldomero, H.2    Schwendener, A.3
  • 6
    • 77956052070 scopus 로고    scopus 로고
    • Defining the risks of mesench-ymal stromal cell therapy
    • Prockop DJ, Brenner M, Fibbe WE, et al. Defining the risks of mesench-ymal stromal cell therapy. Cytotherapy 2010; 12: 576-8.
    • (2010) Cytotherapy , vol.12 , pp. 576-578
    • Prockop, D.J.1    Brenner, M.2    Fibbe, W.E.3
  • 7
    • 85031206972 scopus 로고    scopus 로고
    • US National Institutes of Health (NIH). Clinical Trials.gov. July (cited July 2011)
    • US National Institutes of Health (NIH). Clinical Trials.gov. July 2011 (cited July 2011). http://clinicaltrials.gov
    • (2011)
  • 8
    • 79953050015 scopus 로고    scopus 로고
    • Opportunities in regenerative medicine
    • Buckler RL. Opportunities in regenerative medicine. Bio Process Int 2011; 9: 14-9.
    • (2011) Bio Process Int , vol.9 , pp. 14-19
    • Buckler, R.L.1
  • 9
    • 76749096715 scopus 로고    scopus 로고
    • Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: Current practice in Europe 2009
    • Ljungman P, Bregni M, Brune M, et al. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009. Bone Marrow Transplant 2010; 45: 219-34.
    • (2010) Bone Marrow Transplant , vol.45 , pp. 219-234
    • Ljungman, P.1    Bregni, M.2    Brune, M.3
  • 10
    • 0142094692 scopus 로고    scopus 로고
    • Regulation of cellular therapies: The Australian perspective
    • DOI 10.1080/14653240310002207
    • Wall DM, Prince HM. Regulation of cellular therapies: the Australian perspective. Cytotherapy 2003; 5: 284-8. (Pubitemid 37264994)
    • (2003) Cytotherapy , vol.5 , Issue.4 , pp. 284-288
    • Wall, D.M.P.1    Prince, H.M.2
  • 11
    • 85031205005 scopus 로고    scopus 로고
    • Therapeutic Goods Administration. Therapeutic Goods (Excluded Goods) Order No. 1 of2011. Commonwealth of Australia Gazette 2011; 31 May: S91
    • Therapeutic Goods Administration. Therapeutic Goods (Excluded Goods) Order No. 1 of2011. Commonwealth of Australia Gazette 2011; 31 May: S91.http://www.tga.gov.au/industry/legislation-excluded-goods-order-1101. htm
  • 12
    • 79958021185 scopus 로고    scopus 로고
    • The risk of putting something where it does not belong: Mesenchymal stem cells produce masses in the brain
    • Snyder EY. The risk of putting something where it does not belong: mesenchymal stem cells produce masses in the brain. Exp Neurol 2011; 230: 75-7.
    • (2011) Exp Neurol , vol.230 , pp. 75-77
    • Snyder, E.Y.1
  • 13
    • 33750081777 scopus 로고    scopus 로고
    • FDA regulation of stem-cell-based therapies
    • DOI 10.1056/NEJMhpr063086
    • Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med 2006; 355: 1730-5. (Pubitemid 44583964)
    • (2006) New England Journal of Medicine , vol.355 , Issue.16 , pp. 1730-1735
    • Halme, D.G.1    Kessler, D.A.2
  • 16
    • 84893402749 scopus 로고    scopus 로고
    • Therapeutic Goods Administration Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011. 31 May 2011 (cited July 2011)
    • Therapeutic Goods Administration. Therapeutic Goods Act 1989. Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011. 31 May 2011 (cited July 2011). www.comlaw.gov.au/Details/ F2011L00894
    • Therapeutic Goods Act 1989
  • 17
    • 85031203900 scopus 로고    scopus 로고
    • Therapeutic Goods Administration 1 June (cited July 2011)
    • Therapeutic Goods Administration. Clinical trial regulation in Australia. 1 June 2011 (cited July 2011). www.tga.gov.au/pdf/presentations/presenta-tion- omq-110526-clark.pdf
    • (2011) Clinical Trial Regulation in Australia
  • 19
    • 85031201746 scopus 로고    scopus 로고
    • (Press release). 10 April (cited July 2011)
    • Ellison C. New program for orphan drugs. (Press release). 10 April 1997 (cited July 2011). www.health.gov.au/internet/main/publishing.nsf/ Content/health-archive-mediarel-1997-ceorphan.htm
    • (1997) New Program for Orphan Drugs
    • Ellison, C.1
  • 20
    • 33645202403 scopus 로고
    • Therapeutic Goods Administration Ther-apeutic Goods Order No. 75: Standard For Haematopoietic Progenitor Cells Derived From Cord Blood. 1 August 2007 (cited July 2011)
    • Therapeutic Goods Administration. Therapeutic Goods Act 1989. Ther-apeutic Goods Order No. 75: Standard For Haematopoietic Progenitor Cells Derived From Cord Blood. 1 August 2007 (cited July 2011). www.tga. gov.au/docs/html/tgo/tgo75.htm
    • (1989) Therapeutic Goods Act
  • 21
    • 85031209195 scopus 로고    scopus 로고
    • Therapeutic Goods Administration 24 September 2009 (cited July
    • Therapeutic Goods Administration. Current standards applicable to TGA-licensed HPC manufacturers. 24 September 2009 (cited July 2011). http:// www.tga.gov.au/industry/manuf-btb-hpc-standards.htm
    • (2011) Current Standards Applicable to TGA-licensed HPC Manufacturers
  • 22
    • 77952427875 scopus 로고    scopus 로고
    • Standards, regulations and accreditation for registries involved in the worldwide exchange of hematopoietic stem cell donors and products
    • Hurley CK, Foeken L, Horowitz M, Lindberg B, McGregor M, Sacchi N. Standards, regulations and accreditation for registries involved in the worldwide exchange of hematopoietic stem cell donors and products. Bone Marrow Transplant 2010; 45: 819-24.
    • (2010) Bone Marrow Transplant , vol.45 , pp. 819-824
    • Hurley, C.K.1    Foeken, L.2    Horowitz, M.3    Lindberg, B.4    McGregor, M.5    Sacchi, N.6
  • 23
    • 85031196154 scopus 로고    scopus 로고
    • Foundation for the Accreditation of Cellular Pathology (FACT). July (cited July 2011)
    • Foundation for the Accreditation of Cellular Pathology (FACT). July 2011 (cited July 2011). www.factwebsite.org
    • (2011)
  • 25
    • 7344229196 scopus 로고    scopus 로고
    • Guidelines for the collection, processing, storage and of administration ofhemopoietic stem and progenitor cells for transplantation
    • Report of the Working Party on Hemopoietic Stem Cell Processing, Hematology Discipline Advisory Committee, the Royal College of Pathologists of Australasia
    • To LB, Shepherd KM, Lam-Po-Tang R, Szer J, McGrath KM. Guidelines for the collection, processing, storage and of administration ofhemopoietic stem and progenitor cells for transplantation. Report of the Working Party on Hemopoietic Stem Cell Processing, Hematology Discipline Advisory Committee, the Royal College of Pathologists of Australasia. Pathology 1998; 30: 276-85
    • (1998) Pathology , vol.30 , pp. 276-285
    • To, L.B.1    Shepherd, K.M.2    Lam-Po-Tang, R.3    Szer, J.4    McGrath, K.M.5
  • 26
    • 85031194573 scopus 로고    scopus 로고
    • Requirements for Procedures Related to the Collection
    • National Pathology Accreditation Advisory Council (NPAAC) Canberra: Australian Government Department of Health and Age-ing
    • National Pathology Accreditation Advisory Council (NPAAC). Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Third Edition 2009). Canberra: Australian Government Department of Health and Age-ing, 2009. www.health.gov.au/internet/ main/publishing.nsf/Content/health-npaac-docs-human-haemopoietic.htm
    • (2009) Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Third Edition 2009)
  • 27
    • 77956600148 scopus 로고    scopus 로고
    • Regulatory issues in cord blood banking and transplantation
    • Wall DA. Regulatory issues in cord blood banking and transplantation. Best Pract Res Clin Haematol 2010; 23: 171-7.
    • (2010) Best Pract Res Clin Haematol , vol.23 , pp. 171-177
    • Wall, D.A.1
  • 28
    • 85031196703 scopus 로고    scopus 로고
    • Bone Marrow Donors Worldwide (BMDW). July (cited July 2011)
    • Bone Marrow Donors Worldwide (BMDW). July 2011 (cited July 2011). www.bmdw.org
    • (2011)
  • 29
    • 85031198661 scopus 로고    scopus 로고
    • World Marrow Donor Association (WMDA). 13 July (cited July 2011)
    • World Marrow Donor Association (WMDA). 13 July 2011 (cited July 2011). www.worldmarrow.org
    • (2011)
  • 30
    • 85031202148 scopus 로고    scopus 로고
    • Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). July (cited July 2011)
    • Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). July 2011 (cited July 2011). www.ahcta.org
    • (2011)
  • 33
    • 9444248222 scopus 로고    scopus 로고
    • Just Another Cost Increasing Exercise (JACIE)?
    • DOI 10.1038/sj.bmt.1704651
    • Apperley J. Just another cost increasing exercise (JACIE)? Bone Marrow Transplant 2004; 34: 835-8. (Pubitemid 39562133)
    • (2004) Bone Marrow Transplantation , vol.34 , Issue.10 , pp. 835-838
    • Apperley, J.1
  • 34
    • 79956294709 scopus 로고    scopus 로고
    • Introduction of a quality management system and outcome after hematopoietic stem-cell transplan-tation
    • Gratwohl A, Brand R, Niederwieser D, et al. Introduction of a quality management system and outcome after hematopoietic stem-cell transplan-tation. J Clin Oncol 2011; 29: 1980-6.
    • (2011) J Clin Oncol , vol.29 , pp. 1980-1986
    • Gratwohl, A.1    Brand, R.2    Niederwieser, D.3
  • 36
    • 61349102450 scopus 로고    scopus 로고
    • Haemopoietic stem cell Transplantation for children in Australia and New Zealand 1998-2006: A report on behalf of the Australasian Bone Marrow Transplant Recipient Registry and the Australian and New Zealand Children's Haematology Oncology Group
    • Moore AS, Shaw PJ, Hallahan AR, et al. Haemopoietic stem cell Transplantation for children in Australia and New Zealand, 1998-2006: a report on behalf of the Australasian Bone Marrow Transplant Recipient Registry and the Australian and New Zealand Children's Haematology Oncology Group. Med J Aust 2009; 190: 121-5.
    • (2009) Med J Aust , vol.190 , pp. 121-125
    • Moore, A.S.1    Shaw, P.J.2    Hallahan, A.R.3
  • 37
    • 68349136801 scopus 로고    scopus 로고
    • Umbilical cord blood transplantation: Pros, cons and beyond
    • Stanevsky A, Goldstein G, Nagler A. Umbilical cord blood transplantation: pros, cons and beyond. Blood Rev 2009; 23: 199-204.
    • (2009) Blood Rev , vol.23 , pp. 199-204
    • Stanevsky, A.1    Goldstein, G.2    Nagler, A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.