Granada starts a clinical trial to manufacture artificial corneas
The San Cecilio Hospital coordinates this study that is part of the Andalusian Initiative for Advanced Therapies and in which five public health hospital centers and the University of Granada participate
Andalusia begins a multicenter trial to manufacture and implant artificial corneas in patients with severe ulcers for whom there is currently no effective therapeutic alternative. This project, the first of its kind in Spain, began to be developed this February, once authorization from the Spanish Medicines Agency had been received. Five Andalusian hospitals, the University of Granada and the Regional Blood Transfusion Center and the Tissue Bank of Granada-Almería participate in the study, which is coordinated by the San Cecilio Hospital.
The research work begins with the manufacture of the artificial corneas, which will be carried out in the GMP laboratory (white room) of the Virgen de las Nieves Hospital. In the development of the study in patients, in its different phases, the Sevillian hospitals Virgen Macarena and Virgen del Rocío and the Hospital Puerta del Mar de Cádiz will also participate.
The objective of this trial, which is part of the Andalusian Initiative for Advanced Therapies, is to evaluate the safety and clinical efficacy of a human artificial cornea model in a group of patients with severe corneal pathology. A total of 20 patients with corneal opacity or severe and poorly evolving corneal ulcers are expected to be included. In Andalusia, about 400 cases of this type are diagnosed per year.
In an initial phase, five patients will be included sequentially, with a safety period for a month and a half between each one, who will undergo the graft at Hospital San Cecilio. The first five patients will be studied by the Independent Data Monitoring Committee and once the first safety and feasibility data have been obtained, which are collected during three months after the implantation of the artificial cornea in the fifth patient, the trial will continue, recruiting to the remaining fifteen patients.
At random, five of these patients will have the artificial cornea implanted and another ten will be control patients who will receive an amniotic membrane transplant as a conventional treatment for their severe corneal ulcers. In the event that the patient presents lesions that meet treatment criteria in both eyes, the implant will be performed, only in one of them, the one that, in the opinion of the ophthalmologist in charge of the patient, has a worse prognosis. The other eye may be treated with standard treatment, outside the framework of the clinical trial.
Collaboration with the ibs.GRANADA
Collaboration with the Biosanitary Research Institute of Granada has made it possible to offer this therapeutic alternative for the treatment of patients with severe corneal ulcers through tissue engineering technology developed by the team of professionals Mr. Antonio Campos and Mr. Miguel Alaminos.
This collaboration was born after the recognition that the Ministry of Health and Social Welfare granted to Professor Miguel Alaminos, who obtained the award for Vanguard Research within the 2008 call for the Health Investiga Awards, for a research project carried out consistently in the elaboration of artificial corneas by means of tissue engineering in a rabbit animal model.
After obtaining the aforementioned award, the Andalusian public health system, through the Andalusian Initiative in Advanced Therapies, established the necessary collaboration so that the results obtained at the level of animal experimentation could be transferred to patients affected by serious corneal injuries.
Accreditation of the Medicines Agency
On January 31, the Virgen de las Nieves University Hospital in Granada received authorization from the Spanish Agency for Medicines and Health Products for the manufacture of artificial human corneas, considered as tissue engineering medicine, which will allow the clinical trial to be carried out. For its manufacture, in which professionals from the Regional Blood Transfusion Center of Granada also collaborate, limbal cells and keratocytes are obtained from a part of the cornea extracted from a cadaver donor and cultured on a matrix.
The Virgen de las Nieves University Hospital in Granada was the first Andalusian hospital to receive accreditation by the Spanish Agency for Medicines and Health Products in 2010, for the isolation and expansion of mesenchymal stem cells, which it has recently renewed. It is the center of reference in carrying out the quality controls necessary for the manufacture of advanced therapy medicines for the entire network of clean rooms in Andalusia and this renovation allows the activity that is currently being carried out to continue.
GMP (Good Manufacturing Practice) laboratories are facilities in which drugs are manufactured under the standards of the Standards of Correct Manufacturing (regulations that govern the manufacture of drugs) for use in patients, whether they are drugs considered in the research phase, and that therefore they must be administered under the strict control of clinical trials, or drugs that have already received authorization for routine use in patients. The GMP laboratory of the Virgen de las Nieves Hospital has a total area of approximately 48 square meters in which two production rooms are distributed, as well as the changing rooms necessary for access to said area.
Andalusian Initiative for Advanced Therapies
The Andalusian Initiative in Advanced Therapies is an initiative of the Ministry of Health and Social Welfare, with the collaboration of the Ministry of Economy, Innovation, Science and Employment. With its launch, Andalusia has established the necessary mechanisms to promote the development and application of advanced therapies so that, in a coordinated way and with the support of universities, the pharmaceutical sector, private companies, researchers and patient associations, give a qualitative leap and implement Health research as a competitive element of the community.
The development of lines of research in this field has allowed that there are currently, with this, 18 clinical trials in cell therapy and tissue engineering in different phases of development within the Andalusian health in areas such as immunology, cardiology, neurology, digestive, ophthalmology, hematology, peripheral vascular and gastroenterology. For the development of these tests, the Ministry of Health and Social Welfare has provided the community with an efficient network of specific infrastructures, such as the 10 existing GMP laboratories within the public health system in the provinces of Córdoba, Granada, Málaga and Seville. These laboratories are managed with the support of the Andalusian Initiative in Advanced Therapies, which plays a coordinating role to facilitate the specialization of the different laboratories in different advanced therapy drugs that allow supporting the widest range of clinical research lines possible.
With these actions, the aim is to place Andalusia in a vanguard position in the field of translational biomedical research, a field of action that seeks to find solutions for diseases that currently lack them and that, at the same time, are part of the sustainable economy strategy, since investment in research functions as an engine of economic and social development in Andalusia and its results, therefore, revert to citizens.