The artificial cornea developed in Granada successfully completes its first trial in patients

The pioneering artificial cornea designed and generated from biomaterials and stem cells by scientists from Granada has successfully passed its first clinical trial in humans, and has made it possible to demonstrate its safety once implanted in patients with severe corneal diseases who were practically blind. .

This was announced this morning at a press conference by the researchers themselves, belonging to the Tissue Engineering Group of the University of Granada (UGR) and the Biosanitary Research Institute ibs.GRANADA, who have published the results of this study in the prestigious journal Biomedicine & Pharmacotherapy.

The Tissue Engineering Group (whose members belong to the Department of Histology of the UGR and ibs.GRANADA) created the first artificial cornea in 2006 and, after years of preclinical and experimental research, began in 2014 a clinical trial of the same, 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 and the ibs.GRANADA from the eyes of donors, whose cells were used to manufacture the corneas implanted in this clinical trial.

Five patients with severely reduced vision due to chronic corneal ulcers participated in this clinical trial, the first of its kind to be carried out in Europe. During the years 2014 and 2015, the artificial cornea designed in Granada was implanted.

These patients were between 30 and 75 years of age, and were transplanted at the San Cecilio Clinical Hospital, the Virgen de las Nieves University Hospital and the Virgen Macarena University Hospital.

“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. ”, highlighted Miguel Alaminos, professor of Histology at the UGR, principal investigator of this study. Each patient has been evaluated for 5 years, to guarantee the absence of relevant side effects or complications.

"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", pointed out Professor Alaminos.

And it is that, in the surveys carried out on the patients participating in the trial, they reflected a significant improvement and expressed their satisfaction with the treatment received and, therefore, for having been able to receive this innovative therapy.

multicentre trial

The 5 patients treated in this preliminary trial were treated in the Ophthalmology Services of the San Cecilio Clinical University Hospital, the Virgen de las Nieves University Hospital and the Virgen Macarena University Hospital, with the coordination of the Andalusian Network for Design and Translation of Advanced Therapies of the Ministry of Health and Consumption of the Junta de Andalucía (RAdytTA).

"Today we can affirm, after several years of follow-up, that the artificial cornea designed at the UGR and the ibs.GRANADA has shown its efficacy and safety, successfully exceeding the requirements required for its future use as a drug for advanced therapies", has featured Miguel Alaminos.

Indeed, in 2006 the Histology group began experiments leading to the generation of 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, which we present to society today, highlight, after 5 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”, highlighted Carmen González, a doctor from the Ophthalmology service of the San Cecilio Clinical Hospital and coordinator of the clinical trial.

23 million patients in the world with corneal blindness

Diseases of the cornea are among the leading causes of blindness, with up to 23 million patients worldwide suffering from corneal blindness. The standard treatment for serious diseases of the cornea is corneal transplantation, an operation to which more than 3.000 patients undergo each year in Spain.

"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”, points out Gloria Carmona Sánchez, director of the Andalusian Network for the design and translation of Advanced Therapies of the Health Department of the Junta de Andalucía (RAdytTA).

The artificial cornea designed in Granada is especially useful for patients with corneal lesions, either due to traumatic processes (such as burns with chemical products or accidents) or infection (such as herpes keratitis). When these ulcers do not regenerate properly and give rise to a scar, the corneal tissue is no longer transparent and the patient loses vision.

In addition to the clinical trial that has been presented today, the researchers from Granada are currently conducting a second trial with another nine patients who have also been implanted with this artificial cornea, and will soon launch a third.

Bibliographic reference: Successful restoration of corneal surface integrity with a tissue-engineered allogeneic implant in severe keratitis patients. Biomed Pharmacother. 2023 Mar 27;162:114612. doi: 10.1016/j.biopha.2023.114612