Virgen del Rocío Seeks to Expand Artificial Skin Treatment for Burn Victims Across Spain

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Authorization Timeline and Clinical Integration

The path to authorization required a lengthy regulatory process that began in 2015, according to Gloria Carmona, coordinator of the Andalusian Network for Design and Translation of Advanced Therapies at the Fundación Pública Andaluza Progreso y Salud. The Spanish Agency of Medicines and Medical Devices (AEMPS) granted hospital-use authorization in June 2024, followed by its inclusion in the National Health System’s pharmaceutical provision in May 2025. Prior to the formal approval, clinicians applied the therapy under compassionate use provisions, with the first patient treated in 2016.

According to clinical data from the hospital, the center has treated 23 patients with the artificial skin, comprising 16 adults and seven children. To evaluate the long-term efficacy and safety of the therapy, the hospital launched an observational study in January 2025 tracking all treated patients.

Manufacturing Process and Clinical Application

The creation of the artificial skin involves a coordinated regional medical process. According to Dr. Francisco David Rodríguez Vela, clinical chief of the Burn Unit at Virgen del Rocío, physicians take a 6-square-centimeter skin biopsy from the patient. This sample is transported to the Cell Production and Tissue Engineering Unit at the Hospital Universitario Virgen de las Nieves in Granada.

Over a three- to four-week period, technicians culture keratinocytes to form the epidermis and fibroblasts to form the dermis under strict laboratory controls. The resulting sheets are then returned to Seville for surgical implantation. Purificación Gacto, a plastic surgeon specializing in severe burns at Virgen del Rocío, notes that this engineered approach provides both epidermal and dermal layers, closely resembling natural skin and reducing the risk of contractures while minimizing the required donor site to a small linear scar.

Managing severe burn patients involves navigating extreme medical vulnerabilities. According to Dr. Gacto, the primary clinical difficulty is infection control. Burn patients suffer from compromised immune systems and reside in hospital environments where multi-resistant germs are prevalent.

Starting around the second week post-treatment, patients frequently face bacterial colonization requiring third- and fourth-generation antibiotics. Specialized nursing teams manage delicate post-surgical dressings to protect the newly integrated tissue. Despite these challenges, the therapy significantly cuts down hospital stays and lowers mortality risks for patients with burns covering over 60 percent of their body surface.

Expanding National Access

The Andalusian regional government is currently drafting a report to assess the needs of other Spanish autonomous communities to expand access to the treatment nationwide, according to Carmona. While current autologous products require roughly a month for laboratory cultivation, researchers are exploring allogeneic alternatives in early development phases that could offer a faster solution in the future.

Regional health officials aim to make the therapy accessible across Spain so that patient outcomes depend on medical need rather than geographic location. Several autonomous communities have already contacted the Andalusian center to initiate institutional discussions regarding the technology.