The regulation of allogeneic human cells and tissue products as biomaterials

Biomaterials

Volumn 34, Issue 13, 2013, Pages 3165-3173

  Yano, Kazuo ^a   Tsuyuki, Kenichiro ^a   Watanabe, Natsumi ^a   Kasanuki, Hiroshi ^a   Yamato, Masayuki ^a  

^a TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

Author keywords

Allogeneic cell; Blood; Epithelium; Fibroblast; Mesenchymal stem cell; Wound dressing

Indexed keywords

ADVANCING TECHNOLOGY; ALLOGENEIC CELLS; CLASS 1; CLINICAL TRIAL; CURRENT DEFINITION; EPITHELIUM; HEMATOPOIETIC CELL; HUMAN CELLS; KERATINOCYTES; MEDICAL DEVICES; MESENCHYMAL STEM CELL; ORPHAN DISEASE; REGULATORY AUTHORITIES; REGULATORY ISSUES; STERILIZATION PROCESS; TISSUE PRODUCTS; WOUND DRESSINGS;

BIOMEDICAL EQUIPMENT; BLOOD; CELL CULTURE; FIBROBLASTS; HEALTH CARE;

TISSUE;

BIOMATERIAL;

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ARTICLE; CELL ENGINEERING; DEVICE APPROVAL; DRUG APPROVAL; DRUG LEGISLATION; DRUG RECALL; FIBROBLAST; HEMATOPOIETIC CELL; HUMAN; KERATINOCYTE; MEDICAL DEVICE REGULATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TISSUE ENGINEERING; UNITED STATES;

ANIMALS; BIOCOMPATIBLE MATERIALS; CATTLE; CONSUMER PRODUCT SAFETY; HUMANS; SOCIAL CONTROL, FORMAL; TISSUE ENGINEERING; UNITED STATES;

EID: 84874272761     PISSN: 01429612     EISSN: 18785905     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2013.01.048     Document Type: Article

References (40)

1. Williams D.F. The Williams dictionary of biomaterials 1999, Liverpool University Press, Liverpool.
2. Williams D.F. On the nature of biomaterials. Biomaterials 2009, 30:5897-5909.
3. US Food and Drug Administration Vaccines, blood & biologics topics 2012, Available from URL:. http://www.fda.gov/BiologicsBloodVaccines/default.htm.
4. US Food and Drug Administration Biological approvals by year 2012, Available from: URL:. http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/default.htm.
5. US Food and Drug Administration PMA approvals 2012, Available from URL:. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
6. US Food and Drug Administration Listing of CDRH humanitarian device exemptions 2012, Available from URL:. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.
7. US Food and Drug Administration Appoval letter of dermagraft temporary covering, dermagraft-TC™ 1997, Available from URL:. http://www.accessdata.fda.gov/cdrh_docs/pdf/p960007.pdf.
8. US Food and Drug Administration Apligraf™ (Graftskin)-P950032 1998, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm%3fnum%3dp950032.
9. US Food and Drug Administration Composite cultured skin (CCS)-H990013 2001, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm%3fnum%3dH990013.
10. US Food and Drug Administration OrCel™ Bilayered cellular matrix-P010016 2001, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm%3fnum%3dp010016.
11. ®-P000036 2001, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm%3fnum%3dP000036.
12. US Food and Drug Administration HEMACORD (hematopoietic progenitor cells, cord blood) 2011, Available from URL:. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm279608.htm.
13. US Food and Drug Administration GINTUIT (Allogeneic cultured keratinocytes and fibroblasts in bovine collagen) 2012, Available from URL:. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm295465.htm.
14. The European Medicines Agency Home page the European medicines agency 2012, Available from URL:. http://www.ema.europa.eu/ema/.
15. The Pharmaceuticals and Medical Devices Agency Home pages the pharmaceuticals and medical devices Agency 2012, Available from URL:. http://www.pmda.go.jp/.
16. US Food and Drug Administration List of device recalls 2012, Available from URL:. http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm.
17. US Food and Drug Administration MAUDE-manufacturer and user facility device experience 2012, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
18. US Food and Drug Administration, Department of Health and Human Service Definition of primary mode of action of a combination product. Fed Regist 2005, 70:49848-49862.
19. European Parliament and the Council of the European Union Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinalproducts and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Off J Eur Union 2007, L324:121-137.
20. US Food and Drug Administration Guidance on applications for products comprised of living autologous cells manipulated ex vivo and intended for structural repair or reconstruction. Fedral Regist 1996, 61:26523-26524. Availability:.
21. US Food and Drug Administration Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Fed Regist 2001, 66:5447-5469.
22. US Food and Drug Administration Current good tissue practice for human cells, tissues, and cellular and tissue-based product establishment; inspection and enforcement. Fed Regist 2004, 69:68612-68688.
23. Pharmaceutical and Food Safety Bureau. Quality and safety assurance for drug products manufactured using human- or animal-derived components as raw materials, Appendix 1: Basic policies for handling and using drug products using cells and tissue; Appendix 2: guidance regarding quality and safety assurance for drug products manufactured by processing human-derived cells and tissue (in Japanese). Iyakuhatsu: PFSB notification; 2000. p. 1314.
24. US Food and Drug Administration August 1998 PMA approvals: TransCyte™ P960007/S008 1998, Available from URL:. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm115123.htm.
25. Noordenbos J., Dore C., Hansbrough J.F. Safety and efficacy of TransCyte for the treatment of partial-thickness burns. J Burn Care Rehabil 1999, 20:275-281.
26. ® (Grafskin)-P950032/S016 2000, Available from URL:. http://www.accessdata.fda.gov/cdrh_docs/pdf/P950032S016a.pdf.
27. Veves A., Falanga V., Armstrong D.G., Sabolinski M.L. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care 2001, 24:290-295.
28. US Food and Drug Administration Request for proposed standards for unrelated allogeneic peripheral and placental/umbilical cord bllod hematopoietic stem/progenitor cell products; request for comments. Fed Regist 1998, 63:2985-2988.
29. US Food and Drug Administration Guidance for industry: minimally manipulated, unrelated, allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications; avalability. Fed Regist 2009, 74:53753-53754.
30. US Food and Drug Administration CMC review: BLA125400/0 2012, Available from URL:. http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM297874.pdf.
31. US Food and Drug Administration CFR-Code of Federal regulations title 21, part 814-premarket approval of medical devices, subpart B-premarket approval application (PMA) 2012, Sec. 814.39 PMA supplements, Available from URL:. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm%3ffr%3d814.39.
32. Kessler L.G. Statistical guidance for clinical trials of non diagnostic medical devices 1996, Available from URL:. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106757.htm.
33. US Food and Drug Administration Summary basis for regulatory action 2012, Available from URL:. http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM297753.pdf.
34. US Food and Drug Administration Summary for basis of approval-carticel 1997, Available from URL:. http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM109341.pdf.
35. ® (cultured epidermal autografts)-H990002, summary of safety and probable benefit 2007, Available from URL:. http://www.accessdata.fda.gov/cdrh_docs/pdf/H990002b.pdf.
36. US Food and Drug Administration Summary basis for regulatory action June 20, 2011, Laviv 2011. Available from URL:. http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM262780.pdf.
37. US Food and Drug Administration March 2, 2000 approval letter-carticel 2000, Available from URL:. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm163013.htm.
38. Mason C., Manzotti E. Regenerative medicine cell therapies: numbers of units manufactured and patients treated between 1988 and 2010. Regen Med 2010, 5:307-313.
39. Schmidt C. Gintuit cell therapy approval signals shift at US regulator. Nat Biotechnol 2012, 30:479.
40. US Food and Drug Administration Assessing user fees: PMA supplement definitions, modular PMA fees, BLA and efficacy supplement definitions, bundling multiple devices in a single application, and fees for combination products. Guidance Ind FDA 2003, Available from URL:. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089730.pdf.