2024-03-29T15:40:15Zhttps://uvadoc.uva.es/oai/requestoai:uvadoc.uva.es:10324/405092021-06-24T07:50:10Zcom_10324_40357com_10324_952com_10324_894col_10324_40358
Calonge, Margarita
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0000-0001-8178-4836
Pérez Soto, María Inmaculada
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Galindo de la Rosa, Sara
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0000-0002-3184-2425
Nieto Miguel, Teresa
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500
López Paniagua, Marina
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0000-0002-5712-3322
Fernández Martínez, Itziar
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0000-0002-5077-4448
Alberca Zaballos, Mercedes
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500
García-Sancho Martín, Francisco Javier
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0000-0003-4573-7930
Sánchez García, Ana María de los Ángeles
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0000-0003-3283-8812
Herreras Cantalapiedra, José María
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0000-0001-5487-0579
2020-02-19T10:07:47Z
2020-02-19T10:07:47Z
2019
Translational Research, 2019, vol. 206. p. 18-40
1931-5244
http://uvadoc.uva.es/handle/10324/40509
10.1016/j.trsl.2018.11.003
Producción Científica
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.)
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)
application/pdf
eng
Elsevier
info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc-nd/4.0/
© 2019 Elsevier
Attribution-NonCommercial-NoDerivatives 4.0 Internacional
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
A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency
info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
https://www.sciencedirect.com/science/article/pii/S1931524418302160?via%3Dihub
SI
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Mesenchymal-stem-cells-postprint.pdf
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2021-06-24 09:50:10.32
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