Andalusia launches a clinical trial with an artificial tissue in pediatric patients with cleft lip and palate

The Tissue Engineering Research Group of the University of Granada and the Pediatric Surgery Service of the Virgen de las Nieves University Hospital, begin a pioneering clinical trial in Europe for the treatment of minors with this condition. It will last four years and 15 patients will participate.

The research has been carried out within the framework of the Biosanitary Research Institute ibs.GRANADA, in which both Units are integrated.

Andalusia maintains its commitment to biomedical health research with the aim of continuing to advance in the resolution of complex pathologies. In this sense, professionals from the Pediatric Surgery Service of the Virgen de las Nieves University Hospital in Granada and the research group of tissue engineering of the Department of Histology of the Biosanitary Research Institute of Granada (ibs.GRANADA) and University of Granada, with the support of the Network for the Design and Translation of Advanced Therapies (RAdytTA) of the Progreso y Salud Foundation, have launched the first clinical trial with an artificial tissue in which 15 pediatric patients affected by cleft lip and palate will participate.

The objective of this study, promoted by the Foundation for Biosanitary Research of Eastern Andalusia – Alejandro Otero (FIBAO), is to evaluate the safety and efficacy of the palatal mucosa generated by tissue engineering as a possible autologous substitute (from the patient's own) for the human palatal mucosa in patients with severe congenital anomalies of the oral cavity.

The drug under investigation is a palatal mucosa substitute made from the patient's own cells (keratinocytes and fibroblasts), on a fibrin and agarose biomaterial matrix. The objective of this clinical trial is to evaluate in pediatric patients with this condition the possible regenerative effect and biosafety of the human palatal mucosa previously generated in the laboratory through tissue engineering. Cleft lip and palate is one of the most common congenital malformations and is estimated to affect one in every 700 newborns.

The medication that will be administered to the patients participating in the trial will be manufactured in the GMP Laboratory (Good Manufacturing Practices) of the Cellular Production and Tissue Engineering Unit of Granada located in the Virgen de las Nieves Hospital of Granada belonging to the network of GMP laboratories for advanced therapies of the Public Health System of Andalusia. For their development and correct management, these professionals have the support of the RAdytTA.

The research and clinical trial are led by Ricardo Fernández Valadés, head of the Pediatric Surgery service and co-director of the Cleft Lip and Palatine Unit at the Virgen de las Nieves University Hospital in Granada, and coordinated by Miguel Alaminos, from the Tissue Engineering Group of the University of Granada at the Biosanitary Research Institute. Likewise, it is part of the translational research work carried out at the Biosanitary Research Institute of Granada (ibs.GRANADA) with the coordination of the RAdytTA.

The overall duration of the study, in which 15 patients will participate, is four years: 24 months for the inclusion of the patients and another 24 months for their follow-up.

This clinical trial joins 15 others that are being developed in terms of advanced therapies within the framework of the Andalusian Public Health System, including cell therapy, gene therapy and tissue engineering, with the support of the RAdytTA. Through research in this field and the development of these studies, new avenues are opened to treat diseases and conditions that, today, lack a therapeutic solution. To this end, the RAdytTA coordinates a network of GMP laboratories for advanced therapies distributed throughout different provinces of the Autonomous Community.

In these spaces, which meet the requirements demanded by the Spanish Agency for Medicines and Health Products, 1.232 doses of advanced therapy medicines have been manufactured to date, which have been used to treat more than 800 patients in the context of clinical trials. or administered as compassionate use, or within the service portfolio of Andalusian public hospitals, as is the case of artificial skin for large burns or chondrocytes for joint injuries.