Europe's first artificial palate and lip implant operation carried out in Spain

The first artifial cleft palate and lip implant operation in Europe has been successfully carried out on a 16-month-old baby, Nabila, in Granada. The operation was done on at the city's Virgen de las Nieves university hospital on 19 June and one month later, during an event at the hospital to celebrate the success of the operation, little Nabila's parents, Rosana Garrido and José Luis Anguiz, have said that their daughter is "doing great" and that the preliminary results are "very positive".

Nabila is the first patient with cleft lip and palate to have reconstructive surgery with an artificial palate in Europe. Nabila's cleft lip and palate were first picked up during a scan when Rosana was 20 weeks pregnant.

Nabila was born on 2 February 2023 in the San Juan de la Cruz hospital in Úbeda. José Luis, Rosana and Nabilla have been living in Baeza (Jaén) for 17 months and the check-ups since the diagnosis have been in Granada.

When they were told that there was the possibility of participating in this clinical trial, Rosana and José Luis didn't think twice. Ricardo Fernández is the head of the paediatric surgery department and a member of the cleft lip and palate and craniofacial malformations unit at the Virgen de las Nieves hospital.

The trial is the work of the tissue engineering research group of the department of histology of the University of Granada (UGR) and the Hospital Virgen de las Nieves (although some other bodies have participated).

The research at the UGR was led by Professor Antonio Campos, whose team has been working on such trials for two decades. Professor Miguel Alaminos has since taken over the project. They have already achieved artificial skin, recently recognised as a medicine, and the artificial cornea. And now, the artificial palate is beginning its journey.

They have developed an innovative model of artificial palatal mucosa to treat patients with cleft lip and palate. After preclinical research and quality controls developed over the years by the research group, the researchers from the UGR, along with the Andalusian network for the design and translation of advanced therapies (Radytta) of the Andalusian regional government, obtained authorisation from the Spanish agency for medicines and health products (AEMPS) to start the clinical trial.

The aim of this clinical trial is to improve the results of the current treatment of cleft lip and palate, in order to improve the development of craniofacial structures. Cleft lip and palate is one of the most common congenital conditions affecting one in every 700 newborns.

The close collaboration between the tissue engineering research group and the paediatric surgery service, within the framework of the ibs.Granada Biosanitary Research Institute, has made this achievement possible.

In this pioneering intervention surgeons implanted a tissue medicine made up of the patient's own cells and natural biomaterials specifically designed for this structure. She underwent two operations (one routine at three months and the other at sixteen months).

Miguel Alaminos explained that it has been years of hard work. For this artificial palate they have obtained fourteen research projects and two million euros in total. "In this group we work for the good of patients," he stressed. He called for a commitment to basic research and collaboration to achieve more success stories like Nabila's. Nabila was the first, but there are plans to work with around twenty more patients.

The event was attended by the regional minister of health, Catalina García; the rector of the UGR, Pedro Mercado; the managing director of the Virgen de las Nieves Hospital, María Ángeles García and other representatives from the sector.

The rector expressed that the "best result is Nabila" and the "best prize" for the researchers. García stressed the importance of continuing to work as a team because the "common and sole objective" is the patients. She and Mercado praised the work of the researchers and the doctors.