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

• Published in: Acta ophthalmologica (Oxford, England) Vol. 100; no. 2; pp. e396 - e408
• Main Authors: Rodríguez Calvo‐de‐Mora, Marina, Domínguez‐Ruiz, Cayetano, Barrero‐Sojo, Francisco, Rodríguez‐Moreno, Gustavo, Antúnez Rodríguez, Cristina, Ponce Verdugo, Laura, Hernández Lamas, María del Carmen, Hernández‐Guijarro, Luisa, Villalvilla Castillo, Jacinto, Fernández‐Baca Casares, Idefonso, Prat Arrojo, Isidro, Borroni, Davide, Alba‐Linero, Carmen, Zamorano‐Martín, Francisco, Moreno‐Guerrero, Antonio, Rocha‐de‐Lossada, Carlos
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.03.2022
• Subjects: Acuity; Aged; Albumin; allogeneic serum eye drops; autoimmune disease; Autoimmune diseases; autologous serum eye drops; Clinical trials; Double-Blind Method; Double-blind studies; dry eye; Dry Eye Syndromes - drug therapy; Dry Eye Syndromes - metabolism; Eye diseases; Female; Fibroblast growth factor 2; Fibronectin; Fluorescein; growth factor; Growth factors; haemoderivatives eye drops; Humans; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Male; Middle Aged; ocular surface; Ophthalmic Solutions - administration & dosage; Questionnaires; Serum - metabolism; Sjögren’s syndrome; Transforming growth factor-b; Umbilical cord; umbilical cord serum eye drops; Vitamin A; Vitamins; growth factor; autologous serum eye drops; allogeneic serum eye drops; ocular surface; Sjögren’s syndrome; umbilical cord serum eye drops; dry eye; autoimmune disease; haemoderivatives eye drops
• ISSN: 1755-375X; 1755-3768; 1755-3768
• DOI: 10.1111/aos.14953

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.