Safety and toxicological evaluation of undenatured type II collagen

References

• Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, Howell D, Kaplan D, Koopman W, Longley III S, Mankin H, McShane DJ, Medsger Jr T, Meenan R, Mikkelsen W, Moskowitz R, Murphy W, Rothschild B, Segal M, Sokoloff L, Wolfe F. 1986. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 29:1039–1049.
   PubMed Web of Science ®Google Scholar
• Ames BN, McCann J, Yamasaki E. 1977: Methods for the Salmonella Mutagenicity Test. In: Kilbey BJ, editor. Handbook of mutagenicity test procedures. Amsterdam: Elsevier. pp 1–17.
   Google Scholar
• Bagchi M, Gupta RC, Lindley J, Barnes M, Canerdy TD, Goad JT, Bagchi D. 2009. Suppression of Arthritic Pain in Dogs by Undenatured Type-II Collagen (UC-II) Treatment Quantitatively Assessed by Ground Force Plate Dresden, Germany: EUROTOX.
   Google Scholar
• Bagchi M, Lau FC, Bagchi D. 2008b. Beneficial effects of oral administration of undenatured type II collagen on osteoarthritis: a human clinical trial. Am Coll Nutr, 27: 603.
   Google Scholar
• Bagchi M, Skaggs P, Gupta RC, Canerdy TD, Goad JT, Barnett D, Wegford K, Burke R, Bagchi D. 2008aTherapeutic Efficacy of Undenatured Type II Collagen (UC-II) In Comparison To Glucosamine Plus Chondroitin in Arthritic Horses. San Diego, CA: FASEB. pp LB28.
   Google Scholar
• Barnett ML, Combitchi D, Trentham DE. 1996. A pilot trial of oral type II collagen in the treatment of juvenile rheumatoid arthritis. Arthritis Rheum 39:623–628.
   PubMed Web of Science ®Google Scholar
• Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman M, Fletcher MJ, Chasan-Taber S, Finger E, Morales A, Le CH, Trentham DE 1998. Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum 41:290–297.
   PubMed Web of Science ®Google Scholar
• Berenbaum F. 2008. New horizons and perspectives in the treatment of osteoarthritis. Arthritis Res Ther 10(Suppl 2):S1
   Google Scholar
• Bitton R. 2009. The economic burden of osteoarthritis. Am J Manag Care 15:S230–S235.
   PubMed Web of Science ®Google Scholar
• Clive D. 1983. Viable chromosomal mutations affecting the TK locus in L5178Y/TK+/− mouse lymphoma cells: the other half of the assay. Ann NY Acad Sci 407:253–257.
   PubMed Web of Science ®Google Scholar
• Clive D, McCuen R, Spector JF, Piper C, Mavournin KH. 1983. Specific gene mutations in L5178Y cells in culture. Mutat Res 115:225–251.
   PubMed Web of Science ®Google Scholar
• Clive D, Spector JF. 1975. Laboratory procedure for assessing specific locus mutations at the TK locus in cultured L5178Y mouse lymphoma cells. Mutat Res 31:17–29.
   PubMed Web of Science ®Google Scholar
• Crowley DC, Lau FC, Sharma P, Evans M, Guthrie N, Bagchi M, Bagchi D, Dey D. K, Raychaudhuri S. P. 2009. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci 6:312–321.
   PubMed Web of Science ®Google Scholar
• D’Altilio M, Peal A, Alvey M, Simms C, Curtsinger A, Gupta RC, Canerdy TD, Goad JT, Bagchi M, Bagchi D. 2007. Therapeutic efficacy and safety of undenatured type II collagen singly or in combination with glucosamine and chondroitin in arthritic dogs. Toxicol Mech Methods 17:189–196.
   PubMed Web of Science ®Google Scholar
• Deparle LA, Gupta RC, Canerdy TD, Goad JT, D’Altilio M, Bagchi M, Bagchi D. 2005. Efficacy and safety of glycosylated undenatured type-II collagen (UC-II) in therapy of arthritic dogs. J Vet Pharmacol Ther 28:385–390.
   PubMedGoogle Scholar
• Draize JH, Woodward G, Calvery HO. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membrane. J Pharm Exp Ther 82:377–390.
   Web of Science ®Google Scholar
• FDA. 1987. Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies. In: Services. D. o. H. a. H. Washington, DC. US Food and Drug Administration. pp297–310.
   Google Scholar
• Felson DT. 2009. Developments in the clinical understanding of osteoarthritis. Arthritis Res Ther 11:203.
   PubMed Web of Science ®Google Scholar
• Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, Kington RS, Lane NE, Nevitt MC, Zhang Y, Sowers M, McAlindon T, Spector TD, Poole AR, Yanovski SZ, Ateshian G, Sharma L, Buckwalter JA, Brandt KD, Fries JF. 2000. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med 133:635–646.
   PubMed Web of Science ®Google Scholar
• Goggs R, Vaughan-Thomas A, Clegg PD, Carter SD, Innes JF, Mobasheri A, Shakibaei M, Schwab W, Bondy CA. 2005. Nutraceutical therapies for degenerative joint diseases: a critical review. Crit Rev Food Sci Nutr 45:145–164.
   PubMed Web of Science ®Google Scholar
• Gupta RC, Canerdy TD, Skaggs P, Stocker A, Zyrkowski G, Burke R, Wegford K, Goad JT, Rohde K, Barnett D, DeWees W, Bagchi M, Bagchi D. 2009a. Therapeutic efficacy of undenatured type-II collagen (UC-II) in comparison to glucosamine and chondroitin in arthritic horses. J Vet Pharmacol Ther 32:577–584.
   PubMedGoogle Scholar
• Gupta RC, Lindley J, Barnes M, Minniear J, Goad JT, Canerdy TD, Bagchi M, Bagchi D. 2009b. Pain reduction measured by ground force plate in arthritic dogs treated with type-II collagen. Baltimore, MD: Society of Toxicology.
   Google Scholar
• Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH. 2008. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum 58:15–25.
   PubMed Web of Science ®Google Scholar
• Kay JH, Calandra JC. 1962. Interpretation of eye irritation tests. J Soc Cos Chem 13:281–289.
   Google Scholar
• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F. 2008. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum 58:26–35.
   PubMed Web of Science ®Google Scholar
• Maron DM, Ames BN. 1983. Revised methods for the Salmonella mutagenicity test. Mutat Res 113:173–215.
   PubMed Web of Science ®Google Scholar
• Mitchell AD, Auletta AE, Clive D, Kirby PE, Moore MM, Myhr BC. 1997. The L5178Y/tk+/− mouse lymphoma specific gene and chromosomal mutation assay a phase III report of the U.S. Environmental Protection Agency Gene-Tox Program. Mutat Res 394:177–303.
   PubMed Web of Science ®Google Scholar
• OECD. 1998. Paris: Committee, C. G. a. M.Principles of Good Laboratory Practice Organization for Economic Cooperation and Development.
   Google Scholar
• Peal A, D’Altilio M, Simms C, Alvey M, Gupta RC, Goad JT, Canerdy TD, Bagchi M, Bagchi D. 2007. Therapeutic efficacy and safety of undenatured type-II collagen (UC-II) alone or in combination with (-)-hydroxycitric acid and chromemate in arthritic dogs. J Vet Pharmacol Ther 30:275–278.
   PubMedGoogle Scholar
• Sarzi-Puttini P, Cimmino MA, Scarpa R, Caporali R, Parazzini F, Zaninelli A, Atzeni F, Canesi B. 2005. Osteoarthritis: an overview of the disease and its treatment strategies. Semin Arthritis Rheum 35:1–10.
   PubMed Web of Science ®Google Scholar
• Trentham DE. 1984. Immunity to type II collagen in rheumatoid arthritis: a current appraisal. Proc Soc Exp Biol Med 176:95–104.
   PubMed Web of Science ®Google Scholar
• Trentham DE. 1996. Evidence that type II collagen feeding can induce a durable therapeutic response in some patients with rheumatoid arthritis. Ann NY Acad Sci 778:306–314.
   PubMed Web of Science ®Google Scholar
• Trentham DE, Dynesius-Trentham RA, Orav EJ, Combitchi D, Lorenzo C, Sewell KL, Hafler DA, Weiner HL 1993. Effects of oral administration of type II collagen on rheumatoid arthritis. Science 261:1727–1730.
   PubMed Web of Science ®Google Scholar
• Trentham DE, Halpner AD, Trentham RA, Bagchi M, Kothari SC, Preuss HG, Bagchi D. 2001. Use of undenatured type II collagen in the treatment of rheumatoid arthritis. Clin Pract Altern Med 2: 254–259.
   Google Scholar