Feasibility of localized immunosuppression: 3. Preliminary evaluation of organosilicone constructs designed for sustained drug release in a cell transplant environment using dexamethasone

Pharmazie

Volumn 67, Issue 5, 2012, Pages 394-399

  Song, Y ^a   Margolles Clark, E ^a   Fraker, C A ^a   Weaver, J D ^a   Ricordi, C ^a   Pileggi, A ^a   Stabler, C L ^a   Buchwald, Peter ^a  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ANTIINFLAMMATORY AGENT; BIOMATERIAL; CYCLOSPORIN; DEXAMETHASONE; DIMETICONE; FLUOCINOLONE ACETONIDE; GLUCOCORTICOID; IMMUNOSUPPRESSIVE AGENT; ORGANOSILICON DERIVATIVE; OTELIXIZUMAB; RITUXIMAB; TEPLIZUMAB;

ARTICLE; CELL THERAPY; CELL TRANSPLANTATION; DRUG ACTIVITY; ENGRAFTMENT; FEASIBILITY STUDY; FOREIGN BODY; HUMAN; HYDROPHOBICITY; IMMUNOMODULATION; IMMUNOSUPPRESSIVE TREATMENT; IN VITRO STUDY; INSULIN DEPENDENT DIABETES MELLITUS; MICROENVIRONMENT; SUSTAINED DRUG RELEASE;

ALGORITHMS; ANTI-INFLAMMATORY AGENTS; CELL LINE, TUMOR; CELL TRANSPLANTATION; DELAYED-ACTION PREPARATIONS; DEXAMETHASONE; DIABETES MELLITUS, TYPE 1; DIMETHYLPOLYSILOXANES; DRUG DELIVERY SYSTEMS; EXCIPIENTS; HUMANS; IMMUNOSUPPRESSION; LIPOPOLYSACCHARIDES; SILICONES; SOLUBILITY; TRANSPLANTATION IMMUNOLOGY;

EID: 84862330043     PISSN: 00317144     EISSN: None     Source Type: Journal    
DOI: 10.1691/ph.2012.1697     Document Type: Article

References (67)

1. Arck PC, Gilhar A, Bienenstock J, Paus R (2008) The alchemy of immune privilege explored from a neuroimmunological perspective. Curr Opin Pharmacol 8: 480-489.
2. Association, of Reproductive Health Professionals (2008) The Single-Rod Contraceptive Implant. Washington, DC, pp 20.
3. Bocca N, Buchwald P, Molano RD, et al. (2009) Biohybrid devices and local immunomodulation as opposed to systemic immunosuppression. In: Hallé JP, de Vos P, Rosenberg L (eds), The Bioartificial Pancreas and Other Biohybrid Therapies. Trivandrum, India: Research Signpost, pp. 309-328.
4. Bocca N, Marzorati S, Ricordi C, Molano RD, Brady AC, Villate S, Molina J, Zahr E, Fraker, C, Stabler C, Kenyon NS, Inverardi L, Buchwald P, Pileggi A (2010) Long-term islet allograft survival in a biohybrid device by locally delivered immunosuppression. Am J Transplant 10: 149.
5. Bocca N, Pileggi A, Molano RD, Marzorati S, Wu W, Bodor N, Ricordi C, Buchwald P (2008) Soft corticosteroids for local immunosuppression: exploring the possibility for the use of loteprednol etabonate in islet transplantation. Pharmazie 63: 226-232.
6. Brady AC, Ricordi C, Molano RD, Molina J, Zahr E, Lopez-Cabezas M, Fraker C, Stabler C, Kenyon, NS, Inverardi L, Buchwald P, Pileggi A (2010) Prolonged islet allograft survival in a biohybrid device with localized immunosuppression. Am J Transplant 10: 551.
7. Buchwald P (2008) Glucocorticoid receptor binding: a biphasic dependence on molecular size as revealed by the bilinear LinBiExp model. Steroids 73: 193-208.
8. Buchwald P, Bocca N, Marzorati S, Hochhaus G, Bodor N, Stabler C, Kenyon NS, Inverardi L, Molano RD, Ricordi C, Pileggi A (2010) Feasibility of localized immunosuppression: 1. Exploratory studies with glucocorticoids in a biohybrid device designed for cell transplantation. Pharmazie 65: 421-428.
9. Croxatto HB (2002) Progestin implants for female contraception. Contraception 65: 15-19.
10. Del Amo EM, Urtti A (2008) Current and future ophthalmic drug delivery systems. A shift to the posterior segment. Drug Discov Today 13: 135-343.
11. Deuse T, Blankenberg F, Haddad M, Reichenspurner H, Phillips N, Robbins RC, Schrepfer S (2010) Mechanisms behind local immunosuppression using inhaled tacrolimus in preclinical models of lung transplantation. Am J Respir Cell Mol Biol 43: 403-412.
12. Fort A, Fort N, Ricordi C, Stabler CL (2008) Biohybrid devices and encapsulation technologies for engineering a bioartificial pancreas. Cell Transplant 17: 997-1003.
13. Freise CE, Clemmings S, Clemens LE, Alan T, Ashby T, Ashby E, Burke EC, Roberts JP, Ascher NL (1991) Demonstration of local immunosuppression with methylprednisolone in the sponge matrix allograft model. Transplantation 52: 318-325.
14. Furtado A, Perdigoto R, Oliveira F, Geraldes B, Furtado E, Tomé L, Mota O, Ferrão J, Viana J, Bento C, Vieira H, Neves S (2000) Local immunosuppression in clinical small bowel transplantation (report of two cases). Transplant Proc 32: 1206-1208.
15. Galletti PM, Colton CK, Jaffrin M, Reach G (2006) Artificial pancreas. In: Bronzino JD (ed), The Biomedical Engineering Handbook. Tissue Engineering and Artificial Organs, 3rd ed. Boca Raton, FL: CRC Press, pp. 71.1-71.18.
16. Gibly RF, Graham JG, Luo X, Lowe WL, Jr., Hering BJ, Shea LD (2011) Advancing islet transplantation: from engraftment to the immune response. Diabetologia 54: 2494-2505.
17. Higuchi T (1961) Rate of release of medicaments from ointment bases containing drugs in suspension. J Pharm Sci 50: 874-875.
18. Holan V, Chudickova M, Trosan P, et al (2011) Cyclosporine A-loaded and stem cell-seeded electrospun nanofibers for cell-based therapy and local immunosuppression. J Control Release: 156: 406-412.
19. Hult M, Ortsater H, Schuster G, Graedler F, Beckers J, Adamski J, Ploner A, Jörnvall H, Bergsten P, Oppermann U (2009) Short-term glucocorticoid treatment increases insulin secretion in islets derived from lean mice through multiple pathways and mechanisms. Mol Cell Endocrinol 301: 109-116.
20. Inceoglu S, Siemionow M, Chick L, Craven CM, Lister GD (1994) The effect of combined immunosuppression with systemic low-dose cyclosporin and topical fluocinolone acetonide on the survival of rat hind-limb allografts. Ann Plast Surg 33: 57-65.
21. Jaffe GJ, McCallum RM, Branchaud B, Skalak C, Butuner Z, Ashton P (2005) Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. Ophthalmology 112: 1192-1198.
22. Kim J, Conway A, Chauhan A (2008) Extended delivery of ophthalmic drugs by silicone hydrogel contact lenses. Biomaterials 29: 2259-2269.
23. Kim J, Peng CC, Chauhan A (2010) Extended release of dexamethasone from silicone-hydrogel contact lenses containing vitamin E. J Control Release 148: 110-116.
24. Kizilel S, Garfinkel M, Opara E (2005) The bioartificial pancreas: progress and challenges. Diabetes Technol Ther 7: 968-985.
25. Knisely TL, Hosoi J, Nazareno R, Granstein RD (1994) The presence of biologically significant concentrations of glucocorticoids but little or no cortisol binding globulin within aqueous humor: relevance to immune privilege in the anterior chamber of the eye. Invest. Ophthalmol Vis Sci 35: 3711-3723.
26. Lambillotte C, Gilon P, Henquin JC (1997) Direct glucocorticoid inhibition of insulin secretion. An in vitro study of dexamethasone effects in mouse islets. J Clin Invest 99: 414-423.
27. Langer R (1983) Implantable controlled release systems. Pharmacol Ther 21: 35-51.
28. Lee PI (2011) Modeling of drug release from matrix systems involving moving boundaries: Approximate analytical solutions. Int J Pharm 418: 18-27.
29. Liu P, Ju T, Qiu Y (2006) Diffusion-controlled drug delivery systems. In: Li X, Jasti BR (eds), Design of Controlled Release Drug Delivery Systems. New York: McGraw-Hill, pp. 107-137.
30. Malcolm K, Woolfson D, Russell J, Tallon P, McAuley L, Craig D (2003a) Influence of silicone elastomer solubility and diffusivity on the in vitro release of drugs from intravaginal rings. J Control Release 90: 217-225.
31. Malcolm K, Woolfson D, Russell J, Tallon P, McAuley L, Craig D (2003b) Influence of silicone elastomer solubility and diffusivity on the in vitro release of drugs from intravaginal rings. J Control Release 90: 217-225.
32. Margolles-Clark E, Kenyon NS, Ricordi C, Buchwald P (2010) Effective and specific inhibition of the CD40-CD154 costimulatory interaction by a naphthalenesulphonic acid derivative. Chem Biol Drug Des 76: 305-313.
33. Margolles-Clark E, Umland O, Kenyon NS, Ricordi C, Buchwald P (2009) Small molecule costimulatory blockade: organic dye inhibitors of the CD40-CD154 interaction. J Mol Med 87: 1133-1143.
34. Mellor AL, Munn DH (2008) Creating immune privilege: active local suppression that benefits friends, but protects foes. Nat Rev Immunol 8: 74-80.
35. Mineo D, Pileggi A, Alejandro R, Ricordi C (2009) Point: steady progress and current challenges in clinical islet transplantation Diabetes Care 32: 1563-1569.
36. Miyazawa M, Ito Y, Kosaka N, et al (2008) Role of TNF-alpha and extracellular ATP in THP-1 cell activation following allergen exposure. J Toxicol Sci 33: 71-83.
37. 3H] dexamethasone in rat subcutaneous tissue after delivery from osmotic pumps. Biotechnol Prog 22: 819-824.
38. Muller DW, Golomb G, Gordon D, Levy RJ (1994) Site-specific dexamethasone delivery for the prevention of neointimal thickening after vascular stent implantation. Coron Artery Dis 5: 435-442.
39. Narang AS, Mahato RI (2006) Biological and biomaterial approaches for improved islet transplantation. Pharmacol Rev 58: 194-243.
40. Niederkorn JY (2006) See no evil, hear no evil, do no evil: the lessons of immune privilege. Nat Immunol 7: 354-359.
41. Ozcay N, Fryer J, Grant D, Freeman D, Garcia B, Zhong R (1997) Budesonide, a locally acting steroid, prevents graft rejection in a rat model of intestinal transplantation. Transplantation 63: 1220-1225.
42. Pagano G, Cavallo-Perin P, Cassader M, Bruno A, Ozzello A, Masciola P, Dall'omo AM, Imbimbo B (1983) An in vivo and in vitro study of the mechanism of prednisone-induced insulin resistance in healthy subjects. J Clin Invest 72: 1814-1820.
43. Patil SD, Papadmitrakopoulos F, Burgess DJ (2007) Concurrent delivery of dexamethasone and VEGF for localized inflammation control and angiogenesis. J Control Release 117: 68-79.
44. Pedraza E, Fraker C, Brady AC, Stabler C (2009) Design and development of a highly macroporous silicone scaffold as a bioartificial pancreas for type 1 diabetes. IFMBE Proc 24: 233-234.
45. Pierluissi J, Navas FO, Ashcroft SJ (1986) Effect of adrenal steroids on insulin release from cultured rat islets of Langerhans. Diabetologia 29: 119-121.
46. Pileggi A, Cobianchi L, Inverardi L, Ricordi C (2006a) Overcoming the challenges nowlimiting islet transplantation: a sequential, integrated approach Ann N Y Acad Sci 1079: 383-398.
47. Pileggi A, Molano RD, Ricordi C, Zahr E, Collins J, Valdes R, Inverardi L (2006b) Reversal of diabetes by pancreatic islet transplantation into a subcutaneous, neovascularized device. Transplantation 81: 1318-1324.
48. Pinto E, Zhang B, Song S, Bodor N, Buchwald P, Hochhaus G (2010) Feasibility of localized immunosuppression: 2. PLA microspheres for the sustained local delivery of a soft immunosuppressant. Pharmazie 65: 429-435.
49. Qi D, Rodrigues B (2007) Glucocorticoids produce whole body insulin resistance with changes in cardiac metabolism. Am J Physiol Endocrinol Metab 292: E654-E667.
50. Rafacho A, Marroqui L, Taboga SR, Abrantes JL, Silveira LR, Boschero AC, Carneiro EM, Bosqueiro JR, Nadal A, Quesada I (2010) Glucocorticoids in vivo induce both insulin hypersecretion and enhanced glucose sensitivity of stimulus-secretion coupling in isolated rat islets. Endocrinology 151: 85-95.
51. Ricordi C, Inverardi L, Kenyon NS, Goss J, Bertuzzi F, Alejandro R (2005) Requirements for success in clinical islet transplantation. Transplantation 79: 1298-1300.
52. Rilo HL, Carroll PB, Zeng YJ, Fontes P, Demetris J, Ricordi C (1994) Acceleration of chronic failure of intrahepatic canine islet autografts by a short course of prednisone. Transplantation 57: 181-187.
53. Ruers TJM, Buurman WA, Smits JFM, van der Linden CJ, van Dongen JJ, Struyker-Boudier HA, Kootstra G (1986) Local treatment of renal allografts, a promising way to reduce the dosage of immunosuppressive drugs. Comparison of various ways of administering prednisolone. Transplantation 41: 156-161.
54. Ruers TJM, Daemen MJAP, Thijssen HHW, van der Linden CJ, Buurman WA (1988) Sensitivity of graft rejection in rats to local immunosuppressive therapy. Transplantation 46: 820-825.
55. Sakoda H, Ogihara T, Anai M, Funaki M, Inukai K, Katagiri H, Fukushima Y, Onishi Y, Ono H, Fujishiro M, Kikuchi M, Oka Y, Asano T (2000) Dexamethasone-induced insulin resistance in 3T3-L1 adipocytes is due to inhibition of glucose transport rather than insulin signal transduction. Diabetes 49: 1700-1708.
56. Saltzman WM, Olbricht WL (2002) Building drug delivery into tissue engineering. Nat Rev Drug Discov 1: 177-186.
57. Schrepfer S, Deuse T, Reichenspurner H, Hoffmann J, Haddad M, Fink J, Fischbein MP, Robbins RC, Pelletier MP (2007) Effect of inhaled tacrolimus on cellular and humoral rejection to prevent posttransplant obliterative airway disease. Am J Transplant 7: 1733-1742.
58. Shirbacheh MV, Jones JW, Breidenbach WC, McCabe S, Barker JH, Gruber SA (1998) The case for local immunosuppression in composite tissue allotransplantation. Transplant Proc 30: 2739-2742.
59. Siepmann J, Peppas NA (2011) Higuchi equation: Derivation, applications, use and misuse. Int J Pharm 418: 6-12.
60. Silva AI, de Matos AN, Brons IG, Mateus M (2006) An overview on the development of a bio-artificial pancreas as a treatment of insulindependent diabetes mellitus. Med. Res. Rev. 26: 181-222.
61. Sivin I, Nash H, Waldman S (2002) Jadelle® levonorgestrel rod implants: a summary of scientific data and lessons learned from programmatic experience. New York: Population Council, pp 48.
62. Skyler JS, Ricordi C (2011) Stopping type 1 diabetes: attempts to prevent or cure type 1 diabetes in man. Diabetes 60: 1-8.
63. Solari MG, Washington KM, Sacks JM, Hautz T, Unadkat JV, Horibe EK, Venkataramanan R, Larregina AT, Thomson AW, Lee WP (2009) Daily topical tacrolimus therapy prevents skin rejection in a rodent hind limb allograft model. Plast Reconstr Surg 123: 17S-25S.
64. Wang X, Alfrey EJ, Posselt A, Tafra L, Alak AM, Dafoe DC (1995) Intraportal delivery of immunosuppression to intrahepatic islet allograft recipients. Transpl Int 8: 268-272.
65. Ward WK, Hansen JC, Massoud RG, Engle JM, Takeno MM, Hauch KD (2010) Controlled release of dexamethasone from subcutaneously-implanted biosensors in pigs: Localized anti-inflammatory benefit without systemic effects. J Biomed Mater Res A 94: 280-287.
66. Weber T, Kalbhenn T, Herrmann G, Hanisch E (1997) Local immunosuppression with budesonide after liver transplantation in the rat: a preliminary histomorphological analysis. Transplantation 64: 705-708.
67. Zawalich WS, Tesz GJ, Yamazaki H, Zawalich KC, Philbrick W (2006) Dexamethasone suppresses phospholipase C activation and insulin secretion from isolated rat islets. Metabolism 55: 35-42.