The Tissue Engineering Group of ibs.GRANADA designs the artificial palatal mucosa implanted for the first time in Europe in a 16-month-old baby
The clinical trial carried out in the Cleft Lip and Palatine and Craniofacial Malformations Unit of the Virgen de las Nieves University Hospital in Granada has allowed the treatment of a girl with cleft lip and palate.
El Tissue Engineering Research Group of the Biosanitary Research Institute of Granada ibs.GRANADA and the Department of Histology of the University of Granada has developed an innovative model of artificial palatal mucosa intended for treat patients with cleft lip and palate who were transplanted to a 19-month-old baby on June 16. After preclinical research and quality controls developed for years by the Research Group, researchers from ibs.GRANADA and the UGR achieved, in collaboration with the Andalusian Network for the Design and Translation of Advanced Therapies (RADYTTA) of the Junta de Andalucía , the authorization of the Spanish Agency for Medicines and Health Products (AEMPS) for the start of the clinical trial. The first patient in this trial was the 16-month-old baby who, one month after the transplant, is progressing favorably and whose preliminary results are very positive.
The intervention, carried out by Dr. Ricardo Fernández Valadés, head of the Pediatric Surgery Service and member of the Cleft Labiopalatine and Craniofacial Malformations Unit of the Virgen de las Nieves University Hospital in Granada, consisted of implantation of an artificial palatal mucosa generated by tissue engineering at the level of the patient's palate. This is a pioneering intervention in which, for the first time, a tissue medicine made up of the patient's own cells and natural biomaterials specifically designed for this structure is implanted. The objective of this novel clinical trial is improve the results of current cleft lip and palate treatment, one of the most common congenital malformations that affects one in every 700 newborns, to improve the development of the craniofacial structures of these patients. The close collaboration between the Tissue Engineering Research Group and the Pediatric Surgery Service, within the framework of the ibs.GRANADA Biosanitary Research Institute, has allowed us to achieve this achievement.
The presentation of this pioneering transplant in Europe took place this Thursday, July 18, at the Virgen de las Nieves Hospital with the presence of the rector of the University of Granada, Pedro Mercado Pacheco, and the Minister of Health and Consumer Affairs, Catalina García Carrasco, and the managing director of the Virgen de las Nieves University Hospital, María Ángeles García Rescalvo, among others. For the rector of the UGR, “this milestone is a magnificent example of how collaboration between public institutions contributes to creating a better society and, of course, how the University of Granada and its researchers always aim to help society, in “In this case, people with pathologies such as cleft lip and palate.” The rector thanked the researchers and the Government of Andalusia for their participation in this project, which has its origins in the design and creation of the artificial skin UGRSKIN.
This clinical trial is being developed under the BIOCLEFT project, financed by the Carlos III Health Institute and led by Prof. Miguel Alaminos, co-principal investigator of the Tissue Engineering group at ibs.GRANADA and Professor of the Department of Histology at the University of Granada. Funded with nearly €650.000, the BIOCLEFT project has made it possible to carry out this cutting-edge research in the laboratories of the Department of Histology at the University of Granada. This research is part of the group's previous trajectory, which has previously generated cornea and artificial skin that has recently been authorized by the AEMPS as the first tissue medicine incorporated into the Agency's authorization list for use.
