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Friday, 21 June 2024, 14:59
The Virgen del Rocío University Hospital in Seville is the first centre in Spain to obtain authorisation for hospital use of the advanced therapy medication 'human skin obtained by tissue engineering', for treating patients with severe burns.
This type of treatment had already being used in the major burns unit of the hospital on a compassionate use basis, meaning it was employed when no other treatment options were available.
Catalina García, the Andalusian Regional Minister of Health and Consumer Affairs, who presided over the presentation of this scientific milestone, emphasised that the therapeutic use of human artificial skin offers "numerous benefits". She explained that it "facilitates the rapid and effective healing" of wounds, significantly reducing the risk of infections. "Moreover, it provides a protective barrier that decreases pain and enhances patient comfort, while also improving aesthetic and functional outcomes by minimising scar and contracture formation," she added.
The artificial skin is manufactured according to the specific needs of each patient, optimising compatibility and integration. "This advance also reduces the need for additional grafts, shortening recovery time and improving patients' quality of life," said García.
In order to obtain authorisation from the Spanish medicines and health products agency (AEMPS), the Virgen del Rocío Hospital, together with the Andalusian network for the design and translation of advanced therapies of the Progreso y Salud foundation, prepared a registration dossier containing all the information related to the development of the treatment.
This includes the stages of basic research, clinical research, manufacturing as a medicinal product for human use, as well as all aspects of safety monitoring and pharmacovigilance, so that the quality, safety and efficacy of the medicinal product can be guaranteed.
In addition, the clinical pharmacology unit of Virgen del Rocío is in charge of supervising, together with the Andalusian network for the design and translation of advanced therapies. This treatment is then administered by professionals from the plastic surgery and burns unit.
The major burns unit at the Virgen del Rocío University Hospital is the reference point in Spain's National Health System (CSUR) for the treatment of burn patients in Spain. Each year it treats more than 1,000 emergency patients from all over Andalucía, the Canary Islands, Ceuta, Melilla and part of Extremadura. About 130 of these patients are hospitalised for extended periods due to the need for prolonged wound care and sometimes multiple surgeries to generate healthy new skin. More than 50 professionals are part of this service.
The use of artificial skin is the most innovative treatment available. This skin is generated in public laboratories with an infrastructure that follows very strict quality and safety standards (GMP conditions, Good Manufacturing Practices). The specialists at the Virgen del Rocío have already treated 18 patients, six of them children, with personalised artificial skin cultures, since this treatment was incorporated for compassionate use in 2016.
The GMP laboratory of the cell production and tissue engineering unit at the Virgen de las Nieves University Hospital, coordinated by the Andalusian network for the design and translation of advanced therapies, creates the artificial skin from a sample of the patient's healthy skin taken by specialists in the burn unit.
In the lab, they extract dermis and epidermis cells and integrate them into an agarose fibrin mesh, which is then placed on the patient. Healthy tissue grows on this mesh until it integrates into the new dermis. This project has been developed from its initial preclinical stages in the tissue engineering group at the faculty of medicine, University of Granada.
To date, the Virgen de las Nieves has manufactured more than 12 square metres of artificial human skin sheets from samples sent by the Virgen del Rocío, for the 18 patients treated. This skin has been successfully implanted in patients in the Seville burn unit. This consolidated experience has enabled the Spanish medicines agency to approve the use of artificial skin as a medicine for all types of treatment, and not only for compassionate use.
The profile of patients benefitting from this coverage is very specific: they cannot have active infections on the skin's surface and usually have 60 to 90 per cent of their body surface burned in adults, and more than 30 per cent in paediatric patients.
Álvaro Trigo, who gave his testimony during the presentation of this scientific milestone, is one of the success stories in the use of artificial human skin. In early 2018, at the age of 23, he suffered an accident in Andújar (Jaén), caused by the fireplace flames, which burned 63 percent of his body (arms, legs and back). He spent over two months hospitalised at Virgen del Rocío and, after that, began receiving treatment with artificial human skin, using up to 60 sheets, each 12x12 centimetres, on his back and legs alone.
"The skin is an organ with much more importance than cosmetics or aesthetics. Because when this first barrier is lost massively, it leaves us completely exposed to the outside," explained Purificación Gacto, director of the clinical management unit for plastic surgery and burns, alongside Manuel Ginés Roldán, nursing supervisor. This team of specialists regularly works with the intensive care unit at the Seville hospital, where burn patients are initially admitted from the emergency room until they stabilise.
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