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

Abstract

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.

Visual analysis of autoimmune dry eye studies based on bibliometrics

“…[9] Many clinical randomized controlled trials have been reported, exploring many drugs and therapies for the treatment of autoimmune diseases. Intramuscular injection of ianalumab (VAY736), shown to be effective and safe [10] ; Autologous versus allogeneic versus umbilical cord sera has obvious effect on severe dry eye [11] ; LD-IL-2 was effective and well tolerated in patients with pSS, and it restored immune balance, with enhanced regulatory T cells and CD24highCD27 + B cells. [12] However, there are no high-quality reviews of advances in disease treatment, and the field urgently needs high-quality review articles.…”

Therapeutic Hyper-CL soft contact lens in Sjögren's syndrome

“…Allo-SED was preferred to auto-SED in view of similar efficacy and better logistic organization, as it is made using previously stored blood, with subsequent quicker and more convenient production. 8 , 17 …”

“…The efficacy of SED, both allogenic (allo-SED) and autologous (auto-SED), has been well proved in case of dry eye associated with SS, while the literature regarding the efficacy of contact lens is manly based on no-SS-associated dry eye, with only few studies reporting the results of standard bandage contact lenses and scleral contact lens in patient with SS. 6 , 7 , 8 , 9 , 10 , 11 …”

Update on Dry Eye Disease Treatment: Evidence From Randomized Controlled Trials

“…90 As yet, there are only 4 RCTs on limited number of severe DED patients, which comparatively evaluated the efficacy of allo-PBS versus other serum eye drops, with equivocal results. [85][86][87][88] Umbilical Cord Blood Serum…”