June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
A Randomized Controlled Trial of Cultivated Limbal Epithelial Cells Compared to Mesenchymal Stem Cells for the Treatment of Corneal Failure due to Limbal Stem Cell Deficiency
Author Affiliations & Notes
  • Margarita Calonge
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
  • Jose-Maria Herreras
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
  • Inmaculada Pérez
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
  • Itziar Fernández
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
  • Sara Galindo
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
  • Teresa Nieto-Miguel
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
  • Marina López-Paniagua
    IOBA (Institute of Applied Ophthalmobiology), University of Valladolid, Valladolid, Spain
    CIBER-BBN (Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine), Carlos III National Institute of Health, Valladolid, Spain
  • Mercedes Alberca
    IBGM (Institute of Molecular Biology and Genetics), University of Valladolid and National Research Council (CSIC), Valladolid, Spain
  • Javier García-Sancho
    IBGM (Institute of Molecular Biology and Genetics), University of Valladolid and National Research Council (CSIC), Valladolid, Spain
  • Ana Sánchez
    IBGM (Institute of Molecular Biology and Genetics), University of Valladolid and National Research Council (CSIC), Valladolid, Spain
  • Footnotes
    Commercial Relationships   Margarita Calonge, None; Jose-Maria Herreras, None; Inmaculada Pérez, None; Itziar Fernández, None; Sara Galindo, None; Teresa Nieto-Miguel, None; Marina López-Paniagua, None; Mercedes Alberca, None; Javier García-Sancho, None; Ana Sánchez, None
  • Footnotes
    Support  Advanced Therapies Program (SAS/2481/2009), Ministry of Health, Spain. Regional Center for Regenerative Medicine and Cell Therapy, SAN 1178/200, Castile and Leon, Spain. CIBER-BBN, Spain; Spanish l Network on Cell Therapy (TerCel RD12/0019/0036), Spain.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 3372. doi:
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    • Get Citation

      Margarita Calonge, Jose-Maria Herreras, Inmaculada Pérez, Itziar Fernández, Sara Galindo, Teresa Nieto-Miguel, Marina López-Paniagua, Mercedes Alberca, Javier García-Sancho, Ana Sánchez; A Randomized Controlled Trial of Cultivated Limbal Epithelial Cells Compared to Mesenchymal Stem Cells for the Treatment of Corneal Failure due to Limbal Stem Cell Deficiency. Invest. Ophthalmol. Vis. Sci. 2017;58(8):3372.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Ocular stem cell transplantation derived from donor corneoscleral junction is a functional cell therapy to correct limbal stem cell deficiencies that lead to corneal blinding. Mesenchymal stem cells have been properly tested in animal models of this ophthalmic pathology, but never in human eyes despite the multiple advantages over limbal epithelial cells.

Methods : We conducted a 6- to 12-month randomized, double-masked trial with the hypothesis that bone marrow-derived mesenchymal stem cell transplantation (MSCT) is safe and equally efficient as cultivated limbal epithelial transplantation (CLET) in the management of epithelial recovery in corneas damaged due to limbal epithelial stem cell deficiency. Both cell types were cultured on human amniotic membrane. Primary endpoints included a combination of symptoms, clinical signs, and the objective improvement of the epithelial phenotype in the central cornea by in vivo confocal microscopy.

Results : We included 28 transplants, 11 randomized to CLET and 17 to MSCT. Global success at 6 and 12 months was achieved by 72.7% and 77.8% of CLET cases and by 76.5% and 85.7% of MSCT cases, respectively (no significant differences). Improvement of epithelial phenotype in central cornea at 12 months occurred in 55.6% and 71.4% of CLET and MSCT cases, respectively (no significant difference). There were no serious adverse events related with transplants or medications. Thus, MSCT was safe and as efficacious as CLET.

Conclusions : Our evidence-based approach showed that mesenchymal stem cells transplanted to the ocular surface facilitated recovery of a potentially blinding epithelial pathology due to limbal stem cell deficiency. Since MSCT is more efficient in terms of patient morbidity, time- and resource-consumption, and economic expenditure than CLET, MSCT translation into clinical practice should be pursued. (ClinicalTrials.gov number, NCT01562002.)

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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