메뉴 건너뛰기




Volumn 4, Issue 3, 1998, Pages 239-266

Voluntary guidance for the development of tissue-engineered products

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIAL;

EID: 0031667357     PISSN: 10763279     EISSN: None     Source Type: Journal    
DOI: 10.1089/ten.1998.4.239     Document Type: Review
Times cited : (32)

References (55)
  • 1
    • 0031939960 scopus 로고    scopus 로고
    • Meeting report: Tissue engineered medical products standards: The time is ripe
    • Piciolo, G.L., Helman, K.B., and Johnson, P.C. Meeting report: tissue engineered medical products standards: the time is ripe. Tissue Eng. 4, 5, 1998.
    • (1998) Tissue Eng. , vol.4 , pp. 5
    • Piciolo, G.L.1    Helman, K.B.2    Johnson, P.C.3
  • 3
    • 0004064160 scopus 로고    scopus 로고
    • Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services
    • Proposed Approach to Regulation of Cellular and Tissue-Based Products. Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services, 1997.
    • (1997) Proposed Approach to Regulation of Cellular and Tissue-Based Products
  • 4
    • 0003716535 scopus 로고    scopus 로고
    • Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services
    • Guidance for Human Somatic Cell Therapy and Gene Therapy. Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services, 1998.
    • (1998) Guidance for Human Somatic Cell Therapy and Gene Therapy
  • 7
    • 0028031550 scopus 로고
    • Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation
    • Brittberg, M., Lindahl, A., Nilsson, A., Ohlsson, C., Isaksson, O., and Peterson, L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N. Engl. J. Med. 331, 889, 1994.
    • (1994) N. Engl. J. Med. , vol.331 , pp. 889
    • Brittberg, M.1    Lindahl, A.2    Nilsson, A.3    Ohlsson, C.4    Isaksson, O.5    Peterson, L.6
  • 9
    • 0002458722 scopus 로고    scopus 로고
    • Subarachnoid bovine adrenal chromaffin cell implants for cancer pain management
    • Burgess, F.W., Goddard, M.B., Savavese, D., and Wilkinson, H. Subarachnoid bovine adrenal chromaffin cell implants for cancer pain management. APS Abstr. 54, 1996.
    • (1996) APS Abstr. , vol.54
    • Burgess, F.W.1    Goddard, M.B.2    Savavese, D.3    Wilkinson, H.4
  • 10
    • 0345174461 scopus 로고
    • Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services
    • Points to Consider in Somatic Cell and Gene Therapy. Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services, 1993.
    • (1993) Points to Consider in Somatic Cell and Gene Therapy
  • 18
    • 0004310926 scopus 로고
    • Cold Spring Harbor, NY: Cold Spring Harbor Laboratory
    • Pollack, R., ed. Readings in Mammalian Cell Culture. Cold Spring Harbor, NY: Cold Spring Harbor Laboratory, 1975.
    • (1975) Readings in Mammalian Cell Culture
    • Pollack, R.1
  • 19
    • 0020369710 scopus 로고
    • Dedifferentiated chondrocytes reexpress the differentiated collagen phenotype when cultured in agarose gels
    • Benya, P.D., and Shaeffer, J.D. Dedifferentiated chondrocytes reexpress the differentiated collagen phenotype when cultured in agarose gels. Cell 30, 215, 1982.
    • (1982) Cell , vol.30 , pp. 215
    • Benya, P.D.1    Shaeffer, J.D.2
  • 22
    • 85120512377 scopus 로고    scopus 로고
    • Expression of a stable articular cartilage phenotype without evidence of hypertrophy by adult human articular chondrocytes in vitro
    • in press
    • Binette, F., McQuaid, D.P., Haudenschild, D.R., Yaeger, P.C., McPherson, J.M., and Tubo, R. Expression of a stable articular cartilage phenotype without evidence of hypertrophy by adult human articular chondrocytes in vitro. J. Orthop. Res. (in press).
    • J. Orthop. Res.
    • Binette, F.1    McQuaid, D.P.2    Haudenschild, D.R.3    Yaeger, P.C.4    McPherson, J.M.5    Tubo, R.6
  • 23
    • 0031574479 scopus 로고    scopus 로고
    • Synergistic action of transforming growth factor-beta and insulin-like growth factor-I induces expression of type II collagen and aggrecan genes in adult human articular chondrocyte
    • Yaeger, P.C., Masi, T.L., Buck de Ortiz, J.L., Binette, F., Tubo, R., and McPherson, J.M. Synergistic action of transforming growth factor-beta and insulin-like growth factor-I induces expression of type II collagen and aggrecan genes in adult human articular chondrocyte. Exp. Cell Res. 237, 318, 1997.
    • (1997) Exp. Cell Res. , vol.237 , pp. 318
    • Yaeger, P.C.1    Masi, T.L.2    Buck de Ortiz, J.L.3    Binette, F.4    Tubo, R.5    McPherson, J.M.6
  • 24
    • 0026168650 scopus 로고
    • Gene mapping by in situ hybridization
    • Trask, B.J. Gene mapping by in situ hybridization. Curr. Opin. Genet. Dev. 1, 82, 1991.
    • (1991) Curr. Opin. Genet. Dev. , vol.1 , pp. 82
    • Trask, B.J.1
  • 25
    • 0345606557 scopus 로고
    • Biomaterials: Interfacial phenomena and applications
    • Cooper, S.L., and Peppas, N.A., eds., Structure, Testing and Applications of Biomaterials. Washington, DC: ACS
    • Peppas, N.A. Biomaterials: interfacial phenomena and applications. In: Cooper, S.L., and Peppas, N.A., eds. Structure, Testing and Applications of Biomaterials. ACS Symposium Series, Washington, DC: ACS, 1983, p. 199.
    • (1983) ACS Symposium Series , pp. 199
    • Peppas, N.A.1
  • 27
    • 0344744328 scopus 로고
    • Polyether polyurethans for implantable pacemaker leads
    • Stokes, K., and Cobain, K. Polyether polyurethans for implantable pacemaker leads. Biomaterials 3, 25, 1982.
    • (1982) Biomaterials , vol.3 , pp. 25
    • Stokes, K.1    Cobain, K.2
  • 28
    • 0027990699 scopus 로고
    • Endoscopic treatment of vesicoureteral reflux with a chondrocyte-alginate suspension
    • Atala, A., Kim, W., Paige, K.T., Vacanti, C.H., and Retik, A.B. Endoscopic treatment of vesicoureteral reflux with a chondrocyte-alginate suspension. J. Urol. 152, 641, 1994.
    • (1994) J. Urol. , vol.152 , pp. 641
    • Atala, A.1    Kim, W.2    Paige, K.T.3    Vacanti, C.H.4    Retik, A.B.5
  • 29
    • 0023848647 scopus 로고
    • In vitro and in vivo interactions of cells with biomaterials
    • Ziats, N.P., Miller, K.M., and Anderson, J.M. In vitro and in vivo interactions of cells with biomaterials. Biomaterials 9, 5, 1988.
    • (1988) Biomaterials , vol.9 , pp. 5
    • Ziats, N.P.1    Miller, K.M.2    Anderson, J.M.3
  • 31
    • 0023836090 scopus 로고
    • Effect of implantation site on phagocyte/polymer interaction and fibrous capsule formation
    • Bakker, D., van Blitterswijk, C.A., Hesseling, S.C., Grote, J.J., and Daems, W.T. Effect of implantation site on phagocyte/polymer interaction and fibrous capsule formation. Biomaterials 9, 14, 1988.
    • (1988) Biomaterials , vol.9 , pp. 14
    • Bakker, D.1    Van Blitterswijk, C.A.2    Hesseling, S.C.3    Grote, J.J.4    Daems, W.T.5
  • 32
    • 0022723261 scopus 로고
    • Quantitative characterization of cells at the interface of long-term implants of selected polymers
    • Behling, C.A., and Spector, M. Quantitative characterization of cells at the interface of long-term implants of selected polymers. J. Biomed. Mater. Res. 20, 653, 1986.
    • (1986) J. Biomed. Mater. Res. , vol.20 , pp. 653
    • Behling, C.A.1    Spector, M.2
  • 33
    • 0014135001 scopus 로고
    • Localized interfacial forces resulting from implanted plastics as possible physical factors involved in tumor formation
    • Kordan, H.A. Localized interfacial forces resulting from implanted plastics as possible physical factors involved in tumor formation. J. Theor. Biol. 17, 1, 1967.
    • (1967) J. Theor. Biol. , vol.17 , pp. 1
    • Kordan, H.A.1
  • 34
    • 0022723261 scopus 로고
    • Quantitative characterization of cells at the interface of long-term implants of selected polymers
    • Behling, C.A., and Spector, M. Quantitative characterization of cells at the interface of long-term implants of selected polymers. J. Biomed. Mater. Res. 20, 653, 1986.
    • (1986) J. Biomed. Mater. Res. , vol.20 , pp. 653
    • Behling, C.A.1    Spector, M.2
  • 35
    • 0023138888 scopus 로고
    • Effect of the surface geometry of smooth and porous-coated titanium alloy on the orientation of fibroblasts
    • Inoue, T., Cox, J.E., Pilliar, R.M., and Melcher, A.H. Effect of the surface geometry of smooth and porous-coated titanium alloy on the orientation of fibroblasts. J. Biomed. Mater. Res. 21, 107, 1987.
    • (1987) J. Biomed. Mater. Res. , vol.21 , pp. 107
    • Inoue, T.1    Cox, J.E.2    Pilliar, R.M.3    Melcher, A.H.4
  • 36
    • 0014747183 scopus 로고
    • The significance of implant shape in experimental testing of biological materials: Disc vs. rod
    • Wood, N.K., Kaminski, E.J., and Oglesby, R.J. The significance of implant shape in experimental testing of biological materials: disc vs. rod. J. Biomed. Mater. Res. 4, 1, 1970.
    • (1970) J. Biomed. Mater. Res. , vol.4 , pp. 1
    • Wood, N.K.1    Kaminski, E.J.2    Oglesby, R.J.3
  • 37
    • 0014244037 scopus 로고
    • Some physical factors affecting the acceptance of synthetic materials as tissue implants
    • Davila, J.C., Lautsch, E.V., and Palmer, T.E. Some physical factors affecting the acceptance of synthetic materials as tissue implants. Ann. N. Y. Acad. Sci. 146, 138, 1968.
    • (1968) Ann. N. Y. Acad. Sci. , vol.146 , pp. 138
    • Davila, J.C.1    Lautsch, E.V.2    Palmer, T.E.3
  • 38
    • 0345606554 scopus 로고
    • General surgical considerations
    • von Recum, A.F., ed., New York: Macmillan
    • Mendenhall, H.V. General surgical considerations. In: von Recum, A.F., ed. Handbook of Biomaterials Evaluation. New York: Macmillan, 1986, p. 252.
    • (1986) Handbook of Biomaterials Evaluation , pp. 252
    • Mendenhall, H.V.1
  • 39
    • 0022599411 scopus 로고
    • A comparative study of different B-whitlockite ceramics in rabbit cortical bone with regard to their biodegradation behavior
    • Klein, C.P.A.T., de Groot, K., Driessen, A.A., and van der Lubbe, H.B.M. A comparative study of different B-whitlockite ceramics in rabbit cortical bone with regard to their biodegradation behavior. Biomaterials 7, 144, 1986.
    • (1986) Biomaterials , vol.7 , pp. 144
    • Klein, C.P.A.T.1    De Groot, K.2    Driessen, A.A.3    Van der Lubbe, H.B.M.4
  • 41
    • 0023760420 scopus 로고
    • Encapsulated thymic epithelial cells as a potential treatment for immunodeficiences
    • Christenson, L., Aebischer, P., and Galetti, P.M. Encapsulated thymic epithelial cells as a potential treatment for immunodeficiences. ASAIO 34, 681, 1988.
    • (1988) ASAIO , vol.34 , pp. 681
    • Christenson, L.1    Aebischer, P.2    Galetti, P.M.3
  • 42
    • 0024695923 scopus 로고
    • Tissue reaction to intraperitoneal polymer implants: Species differences and effects of corticoid and doxorubicin
    • Christenson, L., Aebischer, P., McMillan, L., and Galletti, P.M. Tissue reaction to intraperitoneal polymer implants: species differences and effects of corticoid and doxorubicin. J Biomed. Mater. Res. 23, 705, 1989.
    • (1989) J Biomed. Mater. Res. , vol.23 , pp. 705
    • Christenson, L.1    Aebischer, P.2    McMillan, L.3    Galletti, P.M.4
  • 43
    • 0021393856 scopus 로고
    • In vivo biocompatibility studies. II. Biomer. preliminary cell adhesion and surface characterization studies
    • Marchant, R.E., Phua, K., Hiltner, A., and Anderson, J.M. In vivo biocompatibility studies. II. Biomer. preliminary cell adhesion and surface characterization studies, J. Biomed. Mater. Res. 18, 309, 1984.
    • (1984) J. Biomed. Mater. Res. , vol.18 , pp. 309
    • Marchant, R.E.1    Phua, K.2    Hiltner, A.3    Anderson, J.M.4
  • 45
    • 0344311990 scopus 로고
    • Achieving compliance in validation and metrology for cell and gene therapy
    • Ostrovski, S. Achieving compliance in validation and metrology for cell and gene therapy. Biopharmaceuticals 8, 20, 1995.
    • (1995) Biopharmaceuticals , vol.8 , pp. 20
    • Ostrovski, S.1
  • 46
    • 0004102752 scopus 로고
    • Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services
    • Guideline on Sterile Drug Products Produced by Aseptic Processing. Washington, DC: U.S. Food and Drug Administration, Department of Health and Human Services, 1987.
    • (1987) Guideline on Sterile Drug Products Produced by Aseptic Processing
  • 47
    • 0344311989 scopus 로고
    • Microbiological Evaluation of Clean Rooms and Other Controlled Environments
    • United States Pharmacopeial Convention (1116). Microbiological Evaluation of Clean Rooms and Other Controlled Environments. Pharmacopeial Forum 21, 440, 1995.
    • (1995) Pharmacopeial Forum , vol.21 , pp. 440
  • 48
    • 0028711684 scopus 로고
    • Overview of a quality assurance/quality control compliance program consistent with PDA regulations and policies for somatic cell and gene therapies: A four-year experience
    • du Moulin, G.C. Pitkin, Z., Shen, Y.J., Conti, E., Stewart, J.K., Charels, C., and Hamilton, D. Overview of a quality assurance/quality control compliance program consistent with PDA regulations and policies for somatic cell and gene therapies: a four-year experience. Cytotechnology 15, 365, 1994.
    • (1994) Cytotechnology , vol.15 , pp. 365
    • Du Moulin, G.C.1    Pitkin, Z.2    Shen, Y.J.3    Conti, E.4    Stewart, J.K.5    Charels, C.6    Hamilton, D.7
  • 51
    • 0344311988 scopus 로고
    • Use of the Limulus Amebocyte Lysate (LAL) assay in living cell therapies
    • du Moulin, G.C. Use of the Limulus Amebocyte Lysate (LAL) assay in living cell therapies. Biopharm 5, 32, 1992.
    • (1992) Biopharm , vol.5 , pp. 32
    • Du Moulin, G.C.1
  • 52
    • 0004310686 scopus 로고    scopus 로고
    • Geneva: International Organization of Standardization
    • ISO 10993. Parts 1-17. Biological Evaluation of Medical Devices. Geneva: International Organization of Standardization.
    • Biological Evaluation of Medical Devices


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.