Autologous versus allogeneic versus umbilical cord sera for the treatment of severe dry eye disease: a double-blind randomized clinical trial

Marina Rodríguez Calvo-de-Mora (Coresponding Author), Cayetano Domínguez-Ruiz, Francisco Barrero-Sojo, Gustavo Rodríguez-Moreno, Cristina Antúnez Rodríguez, Laura Ponce Verdugo, María del Carmen Hernández Lamas, Luisa Hernández-Guijarro, Jacinto Villalvilla Castillo, Idefonso Fernández-Baca Casares, Isidro Prat Arrojo, Davide Borroni, Carmen Alba-Linero, Francisco Zamorano-Martín, Antonio Moreno-Guerrero, Carlos Rocha-de-Lossada

    Research output: Contribution to journalArticlepeer-review

    1 Citation (Scopus)

    Abstract

    Purpose: To measure the effects of Autologous serum (AS), Allogeneic Serum (HS) and Umbilical Cord serum (CS) eye drops in severe dry eye disease (DES), as well as to characterize and quantify several molecules in the three sera (albumin, fibronectin; Vitamin A and E; IgG, IgA and IgM; Transforming growth factor β; Epithelial growth factor). Methods: Randomized, double-blind, single-centre, three-arm (AS, HS and CS) clinical trial. Sixty-three subjects were included with severe DES, 21 in each arm of the study. Visual acuity, Schirmer test, Breakup time (BUT), lissamine green, fluorescein staining measurements and a questionnaire were performed prior to treatment, and after one-month and three-month follow-up. Results: There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = 0.002, p < 0.001, p < 0.001, p = 0.031 and p < 0.001, respectively), although there was no significant interaction between time and serum type, nor between serum type and the test performed. Regarding the concentration of molecules, in our study AS contained significantly higher concentrations of IgA, IgG and fibronectin whereas HS contained significantly higher concentration of IgM, vitamins A and E, TGF and albumin. Contrary to previous reports, CS did not show higher concentration of any of the molecules analysed. Conclusions and relevance: The three sera were effective in the treatment of severe DES. CS did not contain a higher proportion of molecules compared to AS/HS. More research is needed to assess the effect of AS in patients with DES and autoimmune diseases.

    Original languageEnglish
    Pages (from-to)e396-e408
    JournalActa Ophthalmologica
    Volume100
    Issue number2
    DOIs
    Publication statusPublished - Mar 2022

    Keywords*

    • allogeneic serum eye drops
    • autoimmune disease
    • autologous serum eye drops
    • dry eye
    • growth factor
    • haemoderivatives eye drops
    • ocular surface
    • Sjögren’s syndrome
    • umbilical cord serum eye drops

    Field of Science*

    • 3.2 Clinical medicine

    Publication Type*

    • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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