Granada, (EFE).- The pioneering artificial cornea developed with biomaterials and stem cells by Granada scientists has successfully completed the first trial in patients carried out in Europe, in which its safety has been demonstrated once implanted in patients with serious diseases that were practically blind.
The professor of Histology at the University of Granada (UGR) Miguel Alaminos, and the ophthalmologist at the San Cecilio Clinical Hospital in Granada, Carmen González, have presented the main advances of this pioneering cornea.
The researchers, belonging to the UGR Tissue Engineering Group and the ibs.GRANADA Biosanitary Research Institute, created the first artificial cornea in 2006 and, after years of preclinical and experimental research, began in 2014 a clinical trial authorized by the Spanish Agency of Medicines and Sanitary Products of the Ministry of Health.
Complexity of clinical trials
The artificial cornea implanted in this study was designed from the eyes of donors, whose cells were used to manufacture the implanted corneas in this clinical trial, the first of its kind to be carried out in Europe.
Five patients between the ages of 30 and 75 with severely reduced vision due to chronic corneal ulcers who received the artificial corneal implant designed in Granada during 2014 and 2015 participated in the trial.
“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, so the last one received it in 2015. ”, has detailed Alaminos, principal investigator of this study.
“The results have been really promising, since the implant has proven to be highly biocompatible and, in addition, the five patients, whose vision was almost residual, report having significantly improved their symptoms”, added Alaminos.
The follow-up of the patients for five years has demonstrated the efficacy and safety of the cornea, which has exceeded the requirements for its future use as a medicine for advanced therapies.
Experiments since 2006
The Histology group began experiments in 2006 to generate artificial cornea models using an innovative nanostructured fibrin and agarose biomaterial and stem cells obtained from the cornea itself or from other cellular sources.
“The results of the clinical trial highlight, after five years of follow-up in each patient, the usefulness of the model, as well as a high degree of integration in recipient patients, and tissue restoration of the corneal surface,” said González.
Diseases of the cornea are among the leading causes of blindness, and up to 23 million patients worldwide suffer from corneal blindness, which is standardly treated with a corneal transplant, an operation that more and more are undergoing every year. than 3,000 patients in the country.
“This cornea has the particularity of reproducing the structure of the human cornea, that is, it recreates the natural components of the tissue with stem cells instead of using substances that are not present in the eye”, has clarified the director of the Andalusian Network of design and translation of Advanced Therapies of the Ministry of Health (RAdytTA), Gloria Carmona Sánchez.
In addition to the clinical trial that has been presented today, the researchers are currently conducting a second trial with another nine patients who have already been implanted with this artificial cornea, and will shortly launch a third. EFE