The pioneering artificial cornea designed and generated from biomaterials and stem cells by Grenada scientists has successfully passed its first human clinical trial. This clinical study allowed to demonstrate its safety, once implanted in patients with severe corneal diseases, who were practically blind.
The announcement was made by the researchers themselves, belonging to the Tissue Engineering Group of the University of Granada (UGR) and the Biosanitary Research Institute ibs.GRANADA, who published the research results in the journal Biomedicine and Pharmacotherapy.
The artificial cornea implanted in this study was designed in the laboratory of the Tissue Engineering Group of the UGR from donor eyes.
The Tissue Engineering Group created the first artificial cornea in 2006 and, after years of preclinical and experimental research, started a clinical trial in 2014, authorized by the Spanish Agency for Medicines and Health Products of the Ministry of Health.
The artificial cornea implanted in this study was designed in the laboratory of the Tissue Engineering Group of the UGR from the eyes of donors, whose cells were used to manufacture the corneas for this clinical trial, the first of its kind to be carried out in Europe. It involved five patients aged between 30 and 75 with severely reduced vision due to chronic corneal ulcers.
The transplants were performed during 2014 and 2015 at Hospital Clínico San Cecilio, Hospital Universitario Virgen de las Nieves and Hospital Universitario Virgen Macarena. Each patient was evaluated for five years to ensure the absence of relevant side effects or complications.
The implant proved to be highly biocompatible
Miguel Alaminos, principal investigator of the study
“Due to the complexity of this type of clinical trial, the artificial corneas were implanted three months apart in each patient, to verify that there were no side effects, which is why the last one received it in 2015.”, highlights the professor of Histology at the UGR, Miguel Alaminos, principal investigator of this study, in the note distributed by the University of Granada.
“The results are really promising, as the implant proved to be highly biocompatible and, in addition, the five patients, whose vision was almost residual, reported a significant improvement in their symptoms”, highlights Alaminos. “We can state, after several years of follow-up, that the artificial cornea has demonstrated its efficacy and safety, successfully surpassing the requirements for its future use as a medicine for advanced therapies”, in his own words.
corneal blindness
In 2006, the Histology group started experiments that led to the generation of artificial cornea models from an innovative nanostructured fibrin and agarose biomaterial and stem cells obtained from the cornea itself or from other cellular sources.
The five years of follow-up of each patient highlighted “the usefulness of the model”, as well as “a high degree of integration” in the receptors, as well as the “tissue restoration of the corneal surface”, points out Carmen González , study coordinator.
Corneal diseases are among the leading causes of blindness, with up to 23 million patients worldwide suffering from corneal blindness. The standard treatment for serious corneal diseases is transplantation, an operation that more than 3,000 patients undergo each year in Spain.
Each patient was evaluated for five years to ensure the absence of side effects.
“The artificial cornea used in this clinical trial has the particularity of reproducing the structure of the human cornea, that is, it recreates the natural components of the tissue with stem cells from the patient’s own cornea, instead of using substances that are not present in the eye. ”, says Gloria Carmona, director of the Andalusian Network for the design and translation of Advanced Therapies of the Department of Health of the Government of Andalusia (RAdytTA).
This design is especially useful for people with injuries, either due to traumatic processes (such as chemical burns or accidents) or due to an infection (such as herpetic keratitis). When these ulcers do not regenerate properly and give rise to a scar, the corneal tissue ceases to be transparent and the patient loses sight.
In addition to the clinical trial presented, the researchers from Granada are carrying out a second trial with nine other patients who have already received implants of this artificial cornea and will soon launch a third one.
Reference:
Alaminos, M. et al. “Successful restoration of corneal surface integrity with an allogeneic tissue-engineered implant in patients with severe keratitis” Biomedicine and Pharmacotherapy (2023)