Evaluation of the Efficacy of Human Umbilical Cord Blood Serum in the Treatment of Moderate to Severe Dry Eye Disease: A Double-Blind Randomized Clinical Trial



Validad M H ; Jafari M ; Ghasemi M ; Salehi E ; Payandeh A
Source: Tehran University Medical Journal Published:2026

Abstract

Background: Moderate to severe dry eye disease is a prevalent ocular surface disorder characterized by discomfort, fluctuating vision, and epithelial instability, significantly impacting patients' quality of life. In recent years, biologically derived tear substitutes, particularly umbilical cord blood serum, have attracted attention due to their high concentrations of growth factors, anti-inflammatory components, and regenerative potential. This randomized clinical trial aimed to evaluate the effectiveness of diluted human umbilical cord blood serum in improving clinical parameters of moderate to severe dry eye disease. Methods: This double-blind, randomized controlled trial was conducted in 2025 on patients diagnosed with moderate to severe dry eye disease. Eligible participants were randomly assigned to either the intervention group, receiving 20% umbilical cord blood serum eye drops in combination with artificial tears, or the control group, receiving only artificial tears. Clinical evaluations included best-corrected visual acuity, Ocular surface disease index (OSDI), Tear breakup time (TBUT), corneal fluorescein staining score, tear meniscus height, and blink frequency. Measurements were performed at baseline, one month, and three months after initiation of treatment. Statistical analysis was performed using SPSS with a significance level set at 0.05. Results: The intervention group demonstrated statistically significant improvement in all assessed parameters compared to the control group after three months of treatment (P<0.001). Significant reductions in OSDI scores along with increases in TBUT and tear meniscus height were recorded. Corneal staining and blink frequency also showed marked improvement, indicating enhanced epithelial healing and tear film stability. No significant changes were observed in the control group throughout the study period. Conclusion: Administration of 20% umbilical cord blood serum for three months leads to meaningful improvement in both subjective and objective measures of moderate to severe dry eye disease. Given its regenerative capacity, safety profile, and accessibility, cord blood serum represents a promising therapeutic option, particularly for patients with refractory disease. Copyright © 2026 Validad et al. Published by Tehran University of Medical Sciences. This work is licensed under a Creative Commons Attribution-Non-Commercial 4.0 International license (https://creativecommons.org/licenses/by-nc/4.0/). Non-commercial uses of the work are permitted, provided the original work is properly cited.