-
1
-
-
0031939960
-
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
-
-
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
-
-
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
-
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
-
8
-
-
0344744330
-
Viability of encapsulated human islets following subcutaneous implantation in type I and type II diabetic patients and normal controls
-
Scharp, D.W., Swanson, C.J., Olack, B.J., Latta, P.P., Hegre, O.D., Doherty, E.J., Gentile, F.T., Flavin, K.S., Ansara, M.F., and Lacy, P.E. Viability of encapsulated human islets following subcutaneous implantation in type I and type II diabetic patients and normal controls. Diabetes 43, 1167, 1994.
-
(1994)
Diabetes
, vol.43
, pp. 1167
-
-
Scharp, D.W.1
Swanson, C.J.2
Olack, B.J.3
Latta, P.P.4
Hegre, O.D.5
Doherty, E.J.6
Gentile, F.T.7
Flavin, K.S.8
Ansara, M.F.9
Lacy, P.E.10
-
9
-
-
0002458722
-
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
-
-
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
-
-
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
-
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
-
21
-
-
0016927159
-
Fluorescence activated cell-sorting
-
Herzenburg, L.A., Sweet, R.G., and Herzenburg, L.A. Fluorescence activated cell-sorting. Sci. Am. 234, 108, 1976.
-
(1976)
Sci. Am.
, vol.234
, pp. 108
-
-
Herzenburg, L.A.1
Sweet, R.G.2
Herzenburg, L.A.3
-
22
-
-
85120512377
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
40
-
-
0022558005
-
Note: Biodegradation of and tissue reaction to poly(DL-lactide) microcapsules
-
Visscher, O.E., Robison, R.L., Maulding, H.V., Fong, J.W., Pearson, J.E., and Argentieri, G.J. Note: biodegradation of and tissue reaction to poly(DL-lactide) microcapsules. J. Biomed. Mater. Res. 20, 667, 1986.
-
(1986)
J. Biomed. Mater. Res.
, vol.20
, pp. 667
-
-
Visscher, O.E.1
Robison, R.L.2
Maulding, H.V.3
Fong, J.W.4
Pearson, J.E.5
Argentieri, G.J.6
-
41
-
-
0023760420
-
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
-
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
-
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
-
44
-
-
0027976361
-
Detection of bacteremia by DIFCO ESP blood culture system
-
Morello, J., Leitch, C., Nitz, S., Dyke, J.W., Andrusezeski, M., Maier, G., Ladau, W., and Beard, M. Detection of bacteremia by DIFCO ESP blood culture system. J. Clin. Microbiol. 32, 811, 1994.
-
(1994)
J. Clin. Microbiol.
, vol.32
, pp. 811
-
-
Morello, J.1
Leitch, C.2
Nitz, S.3
Dyke, J.W.4
Andrusezeski, M.5
Maier, G.6
Ladau, W.7
Beard, M.8
-
45
-
-
0344311990
-
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
-
-
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
-
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
-
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
-
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
-
-
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
-
-
-
55
-
-
0345174453
-
Biomaterials and the immune system
-
part A
-
Olson, M.E., Elri, H., Morck, D.W., and Lee, C.C. Biomaterials and the immune system. In: Encyclopedic Handbook of Biomaterials and Bioengineering. Vol. 1. 1995, pp. 433-467(part A).
-
(1995)
Encyclopedic Handbook of Biomaterials and Bioengineering
, vol.1
, pp. 433-467
-
-
Olson, M.E.1
Elri, H.2
Morck, D.W.3
Lee, C.C.4
|