The Spanish Medicines Agency authorizes UGRSKIN, the artificial skin created by scientists from ibs.GRANADA, as a medicine for hospital use
Considered an advanced therapy medicine, it was designed by the Tissue Engineering Group of the Department of Histology of the Faculty of Medicine of the UGR and the Biosanitary Research Institute ibs.GRANADA
In 2012, a team of scientists from ibs.GRANADA and the UGR, led by professor Antonio Campos, created the artificial skin known as UGRSKIN. Now, twelve years later and with notable evolution, the Spanish Medicines Agency has authorized its hospital use for use in large burns at the Virgen del Rocío Hospital in Seville. Until now, it was used as an experimental compassionate use drug, that is, when it was not possible to use another type of treatment, which required case-by-case authorization. UGRSKIN is a human skin obtained by tissue engineering that has also become the first artificial tissue approved and authorized in Spain as a medicine.
The presentation of this authorization took place this Tuesday, June 18, at the Virgen del Rocío hospital in Seville and was attended, among others, by the rector of the University of Granada, Pedro Mercado Pacheco, the Minister of Health and Consumption of the Junta de Andalucía, Catalina García, and Antonio Campos and Miguel Alaminos, heads of the group TEC03-Tissue Engineering from ibs.GRANADA and the research team that created UGRSKIN. For the counselor, the new medication, of which 12 square meters have already been manufactured at the Virgen de las Nieves hospital in Granada, “facilitates the rapid and effective healing of wounds, significantly reducing the risk of infections. In addition, it provides a protective barrier that reduces pain and improves patient comfort, without forgetting that it improves aesthetic and functional results, minimizing the formation of scars and contractures. “Artificial skin shortens recovery time and improves the quality of life of patients.” The profile of the patient who benefits from this coverage is very specific: they cannot present active infections on the skin surface and usually have 60 to 90 percent of their body surface burned in adult patients, and more than 30 percent if it is a pediatric patient.
For his part, the rector of the University of Granada recalled the efforts of the researchers and the university institution itself in recent years and the good results obtained in the tests. UGRSKIN has not only shown great usefulness for the treatment of severely burned patients, but it does not generate any side effects or relevant complications. He Professor Miguel Alaminos commented just three months ago, in the presentation of the results of this skin in a patient, that “once implanted, the UGRSKIN model was quickly integrated into the patient's tissue, showing an epidermis very similar to the normal human epidermis from the first moments that, therefore , contributes to the protection of the patient against possible external pathogens. Likewise, the dermis of the implanted tissue was able to progressively remodel until it became histologically analogous to the normal dermis from the second month of implant evolution."
Directed by Antonio Campos, the Tissue Engineering Group of the Biosanitary Research Institute ibs.GRANADA and the Department of Histology of the Faculty of Medicine of the University of Granada is a pioneer in the design and manufacture of artificial human tissues and the result of its work is UGR SKIN, invented in 2012, the year in in which the first articles about her were also published. It was an artificial skin model based on human skin cells and natural biomaterials designed by the research group itself. The group managed to demonstrate the effectiveness of this skin model in experimental animals and managed to develop all the quality controls necessary for the characterization of said model, according to the requirements of the different drug agencies.
Subsequently, after demonstrating the potential usefulness of the UGRSKIN model, the group from ibs.GRANADA and the UGR managed, in close collaboration with the Andalusian Network for the design and translation of Advanced Therapies (RAdytTA) of the Government of Andalusia, to manufacture this skin. artificial in pharmaceutical quality for use as an advanced therapy medicine in accordance with the regulations of the Spanish Agency for Medicines and Health Products (AEMPS), complying with all existing quality standards in Europe.
In this way, and once approved by the AEMPS, in 2016 the UGRSKIN artificial skin was used for the first time to treat a patient who had severe burns on 70% of her body surface in the reference Burn Unit of Andalusia. located in the Virgen del Rocío Hospital in Seville, with good results. Since then, a total of 15 patients (8 adults and 4 children) have been treated, with an overall survival close to 80%. Now, UGRSKIN has authorization that will allow its regular use in accredited burn units in all hospital centers in Spain.
