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    Por favor, use este identificador para citar o enlazar este ítem:http://uvadoc.uva.es/handle/10324/40509

    Título
    A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency
    Autor
    Calonge, MargaritaAutoridad UVA Orcid
    Pérez Soto, María InmaculadaAutoridad UVA
    Galindo de la Rosa, SaraAutoridad UVA Orcid
    Nieto Miguel, TeresaAutoridad UVA Orcid
    López Paniagua, MarinaAutoridad UVA Orcid
    Fernández Martínez, ItziarAutoridad UVA Orcid
    Alberca Zaballos, María MercedesAutoridad UVA Orcid
    García-Sancho Martín, Francisco JavierAutoridad UVA Orcid
    Sánchez García, Ana María de los ÁngelesAutoridad UVA Orcid
    Herreras Cantalapiedra, José MaríaAutoridad UVA Orcid
    Año del Documento
    2019
    Editorial
    Elsevier
    Descripción
    Producción Científica
    Documento Fuente
    Translational Research, 2019, vol. 206. p. 18-40
    Zusammenfassung
    Ocular stem cell transplantation derived from either autologous or allogeneic donor corneoscleral junction is a functional cell therapy to manage extensive and/or severe limbal stem cell deficiencies that lead to corneal epithelial failure. Mesenchymal stem cells have been properly tested in animal models of this ophthalmic pathology, but never in human eyes despite their potential advantages. We conducted a 6- to 12-month proof-of-concept, randomized, and double-masked pilot trial to test whether allogeneic bone marrow-derived mesenchymal stem cell transplantation (MSCT], n = 17) was as safe and as equally efficient as allogeneic cultivated limbal epithelial transplantation (CLET), (n = 11) to improve corneal epithelial damage due to limbal stem cell deficiency. Primary endpoints demanded combination of symptoms, signs, and the objective improvement of the epithelial phenotype in central cornea by in vivo confocal microscopy. This proof-of-concept trial showed that MSCT was as safe and efficacious as CLET. Global success at 6–12 months was 72.7%–77.8% for CLET cases and 76.5%–85.7% for MSCT cases (not significant differences). Central corneal epithelial phenotype improved in 71.4% and 66.7% of MSCT and CLET cases, respectively at 12 months (P = 1.000). There were no adverse events related to cell products. This trial suggests first evidence that MSCT facilitated improvement of a diseased corneal epithelium due to lack of its stem cells as efficiently as CLET. Consequently, not only CLET but also MSCT deserves more preclinical investigational resources before the favorable results of this proof-of-concept trial could be transformed into the larger numbers of the multicenter trials that would provide stronger evidence. (ClinicalTrials.gov number, NCT01562002.)
    Palabras Clave
    Clinical trial
    Ensayo clínico
    Corneal blindness
    Ceguera corneal
    In vivo confocal microscopy
    Microscopía confocal in vivo
    Mesenchymal stem cells
    Células madre mesenquimales
    Stem cell transplantation
    Células madre, Trasplante de
    ISSN
    1931-5244
    Revisión por pares
    SI
    DOI
    10.1016/j.trsl.2018.11.003
    Patrocinador
    Ministerio de Sanidad, Consumo y Bienestar Social (project SAS/2481/2009)
    Centro en Red de Medicina Regenerativa y Terapia Celular de Castilla y León (grant SAN 1178/200)
    Red de Terapia Celular TerCel (project RD12/0019/0036)
    Version del Editor
    https://www.sciencedirect.com/science/article/pii/S1931524418302160?via%3Dihub
    Propietario de los Derechos
    © 2019 Elsevier
    Idioma
    eng
    URI
    http://uvadoc.uva.es/handle/10324/40509
    Tipo de versión
    info:eu-repo/semantics/acceptedVersion
    Derechos
    openAccess
    Aparece en las colecciones
    • IOBA - Artículos de revista [82]
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    Dateien zu dieser Ressource
    Nombre:
    Mesenchymal-stem-cells-postprint.pdf
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    742.7Kb
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