Successful restoration of corneal surface integrity with a tissue-engineered allogeneic implant in severe keratitis patients
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González Gallardo, Carmen; Garzón Bello, Ingrid Johanna; Campos Muñoz, Antonio Jesús; Alaminos Mingorance, MiguelEditorial
Elsevier
Materia
Tissue bioengineered cornea Clinical trial Corneal transplantation Severe keratitis Limbal stem cell deficiency
Date
2023-03-28Referencia bibliográfica
C. Gonz´alez-Gallardo et al. Successful restoration of corneal surface integrity with a tissue-engineered allogeneic implant in severe keratitis patients. Biomedicine & Pharmacotherapy 162 (2023) 114612[https://doi.org/10.1016/j.biopha.2023.114612]
Sponsorship
Biobank of the Andalusian Public Health SystemAbstract
Objectives: Corneal diseases are among the main causes of blindness, with approximately 4.6 and 23 million
patients worldwide suffering from bilateral and unilateral corneal blindness, respectively. The standard treatment
for severe corneal diseases is corneal transplantation. However, relevant disadvantages, particularly in
high-risk conditions, have focused the attention on the search for alternatives.
Methods: We report interim findings of a phase I-II clinical study evaluating the safety and preliminary efficacy of
a tissue-engineered corneal substitute composed of a nanostructured fibrin-agarose biocompatible scaffold
combined with allogeneic corneal epithelial and stromal cells (NANOULCOR). 5 subjects (5 eyes) suffering from
trophic corneal ulcers refractory to conventional treatments, who combined stromal degradation or fibrosis and
limbal stem cell deficiency, were included and treated with this allogeneic anterior corneal substitute.
Results: The implant completely covered the corneal surface, and ocular surface inflammation decreased
following surgery. Only four adverse reactions were registered, and none of them were severe. No detachment,
ulcer relapse nor surgical re-interventions were registered after 2 years of follow-up. No signs of graft rejection,
local infection or corneal neovascularization were observed either. Efficacy was measured as a significant
postoperative improvement in terms of the eye complication grading scales. Anterior segment optical coherence
tomography images revealed a more homogeneous and stable ocular surface, with complete scaffold degradation
occurring within 3–12 weeks after surgery.
Conclusions: Our findings suggest that the surgical application of this allogeneic anterior human corneal substitute
is feasible and safe, showing partial efficacy in the restoration of the corneal surface.