The artificial skin development began at the Tissue Engineering Research Group of the University of Granada 10 years ago. By the end of 2014, this multidisciplinary work group managed to standardise the manufacturing process and quality control of this innovative skin substitute with improved resistance, consistency, elasticity and easy-handling.
In the clinical field, a patient presenting 70% of the body surface deeply burned underwent two interventions for skin transplantation with this product achieving tissue regeneration and patient survival. At the end of 2017, a total of 4 patients in 2016 and 5 in 2017 have been treated with the autologous artificial skin obtaining a positive outcome. Safety and efficacy of these grafts have been proved together with a good prognosis of recovery.
The artificial skin is in a pending authorization process for hospital use, although it’s currently approved its compassionate use outside of a clinical trial, according to Spanish Royal decree 477/2014.
Given the promising results of the fibrin-agarose technology, it has been decided over the years to promote studies on several indications, developing a wide pipeline of clinical and preclinical developments:
In fact, the bioengineered human skin substitute is the result of the experience gained in the most advanced use of fibrin-agarose technology, the artificial cornea for the treatment of Corneal Ulcers which its clinical trial (NCT01765244) is currently ongoing with promising results.