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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024328-53 | EudraCT Number |
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Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy
Intralesional use by inject of adipose derived stem cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Stem Cells | Experimental | Autologous expanded adipose-derived stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded adipose-derived stem cells | Drug | Local injection of autologousadipose derived stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy | Micro ocular Photography Visual acuity | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment using the SF-12 Questionnaire | SF-12 questionnaire | 1, 4, 16, 24 weeks |
| Adverse events | Data collection | 1, 4, 16, 24 weeks |
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Inclusion Criteria:
-Signed informed consent
-Previously diagnosed bilateral limbic obstruction
-Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
-Suffering chronic keratopathy accomplishing the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariano GarcÃa-Arranz, PhD | Contact | 0034 912071022 | mgarciaa.hulp@salud.madrid.org | |
| Ana Boto de los Bueis, MD | Contact | 0034 912071022 | mgarciaa.hulp@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Ana Boto de los Bueis, MD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14703705 | Background | Nishida K. Tissue engineering of the cornea. Cornea. 2003 Oct;22(7 Suppl):S28-34. doi: 10.1097/00003226-200310001-00005. | |
| Background | Arntz Bustos A, Durán de la Colina JA. AnatomÃa funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12 | ||
| 2424919 |
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| Background |
| Schermer A, Galvin S, Sun TT. Differentiation-related expression of a major 64K corneal keratin in vivo and in culture suggests limbal location of corneal epithelial stem cells. J Cell Biol. 1986 Jul;103(1):49-62. doi: 10.1083/jcb.103.1.49. |
| 3897935 | Background | Tseng SC. Staging of conjunctival squamous metaplasia by impression cytology. Ophthalmology. 1985 Jun;92(6):728-33. doi: 10.1016/s0161-6420(85)33967-2. |
| 2748125 | Background | Kenyon KR, Tseng SC. Limbal autograft transplantation for ocular surface disorders. Ophthalmology. 1989 May;96(5):709-22; discussion 722-3. doi: 10.1016/s0161-6420(89)32833-8. |
| 16023069 | Background | Santos MS, Gomes JA, Hofling-Lima AL, Rizzo LV, Romano AC, Belfort R Jr. Survival analysis of conjunctival limbal grafts and amniotic membrane transplantation in eyes with total limbal stem cell deficiency. Am J Ophthalmol. 2005 Aug;140(2):223-30. doi: 10.1016/j.ajo.2005.03.022. |
| 1694836 | Background | Chen JJ, Tseng SC. Corneal epithelial wound healing in partial limbal deficiency. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1301-14. |
| 8628556 | Background | Tan DT, Ficker LA, Buckley RJ. Limbal transplantation. Ophthalmology. 1996 Jan;103(1):29-36. doi: 10.1016/s0161-6420(96)30737-9. |
| 11986089 | Background | Samson CM, Nduaguba C, Baltatzis S, Foster CS. Limbal stem cell transplantation in chronic inflammatory eye disease. Ophthalmology. 2002 May;109(5):862-8. doi: 10.1016/s0161-6420(02)00994-6. |
| 9097796 | Background | Tsubota K, Toda I, Saito H, Shinozaki N, Shimazaki J. Reconstruction of the corneal epithelium by limbal allograft transplantation for severe ocular surface disorders. Ophthalmology. 1995 Oct;102(10):1486-96. doi: 10.1016/s0161-6420(95)30841-x. |
| 12093650 | Background | Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface disorders. Ophthalmology. 2002 Jul;109(7):1278-84. doi: 10.1016/s0161-6420(02)01081-3. |
| 17959397 | Background | Pellegrini G, De Luca M, Arsenijevic Y. Towards therapeutic application of ocular stem cells. Semin Cell Dev Biol. 2007 Dec;18(6):805-18. doi: 10.1016/j.semcdb.2007.09.011. Epub 2007 Sep 16. |
| 16458679 | Background | Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation. Am J Ophthalmol. 2006 Feb;141(2):267-275. doi: 10.1016/j.ajo.2005.09.003. |
| 7499085 | Background | Yao YF, Inoue Y, Miyazaki D, Shimomura Y, Ohashi Y, Tano Y. Ocular resurfacing and alloepithelial rejection in a murine keratoepithelioplasty model. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2623-33. |
| 15745776 | Background | Daya SM, Watson A, Sharpe JR, Giledi O, Rowe A, Martin R, James SE. Outcomes and DNA analysis of ex vivo expanded stem cell allograft for ocular surface reconstruction. Ophthalmology. 2005 Mar;112(3):470-7. doi: 10.1016/j.ophtha.2004.09.023. |
| 14703711 | Background | Nakamura T, Kinoshita S. Ocular surface reconstruction using cultivated mucosal epithelial stem cells. Cornea. 2003 Oct;22(7 Suppl):S75-80. doi: 10.1097/00003226-200310001-00011. |
| 15377551 | Background | Nakamura T, Inatomi T, Sotozono C, Amemiya T, Kanamura N, Kinoshita S. Transplantation of cultivated autologous oral mucosal epithelial cells in patients with severe ocular surface disorders. Br J Ophthalmol. 2004 Oct;88(10):1280-4. doi: 10.1136/bjo.2003.038497. |
| 15371576 | Background | Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455. |
| 9730979 | Background | Lehrer MS, Sun TT, Lavker RM. Strategies of epithelial repair: modulation of stem cell and transit amplifying cell proliferation. J Cell Sci. 1998 Oct;111 ( Pt 19):2867-75. doi: 10.1242/jcs.111.19.2867. |
| 16109757 | Background | Ma Y, Xu Y, Xiao Z, Yang W, Zhang C, Song E, Du Y, Li L. Reconstruction of chemically burned rat corneal surface by bone marrow-derived human mesenchymal stem cells. Stem Cells. 2006 Feb;24(2):315-21. doi: 10.1634/stemcells.2005-0046. Epub 2005 Aug 18. |
| 19074417 | Background | Blazejewska EA, Schlotzer-Schrehardt U, Zenkel M, Bachmann B, Chankiewitz E, Jacobi C, Kruse FE. Corneal limbal microenvironment can induce transdifferentiation of hair follicle stem cells into corneal epithelial-like cells. Stem Cells. 2009 Mar;27(3):642-52. doi: 10.1634/stemcells.2008-0721. |
| 19156227 | Background | Gu S, Xing C, Han J, Tso MO, Hong J. Differentiation of rabbit bone marrow mesenchymal stem cells into corneal epithelial cells in vivo and ex vivo. Mol Vis. 2009;15:99-107. Epub 2009 Jan 16. |
| 18065394 | Background | Arnalich-Montiel F, Pastor S, Blazquez-Martinez A, Fernandez-Delgado J, Nistal M, Alio JL, De Miguel MP. Adipose-derived stem cells are a source for cell therapy of the corneal stroma. Stem Cells. 2008 Feb;26(2):570-9. doi: 10.1634/stemcells.2007-0653. Epub 2007 Dec 6. |
| 38152876 | Derived | Boto de Los Bueis A, Vidal Arranz C, Del Hierro-Zarzuelo A, Diaz Valle D, Mendez Fernandez R, Gabarron Hermosilla MI, Benitez Del Castillo JM, Garcia-Arranz M. Long-Term Effects of Adipose-Derived Stem Cells for the Treatment of Bilateral Limbal Stem Cell Deficiency. Curr Eye Res. 2024 Apr;49(4):345-353. doi: 10.1080/02713683.2023.2297342. Epub 2023 Dec 28. |