New publication reports 1-year phase II results for denovoSkin™ in reconstructive surgery

A new peer-reviewed publication reports 1-year results from a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial evaluating denovoSkin™ in reconstructive surgery in patients of all ages.

The study evaluated denovoSkin™ against autologous split-thickness skin grafts (STSG) in 23 patients with full-thickness skin defects requiring planned elective reconstruction. According to the publication, denovoSkin™ demonstrated significantly better scar quality than STSG at 3 months, with benefits maintained at 12 months. Elasticity parameters also consistently favored denovoSkin™, and significant donor site sparing was also demonstrated.

The authors conclude that denovoSkin™ is a safe and effective treatment for full-thickness skin defects and provides favorable skin quality over 12 months.

The study was conducted across sites in Italy, the Netherlands and Switzerland. denovoSkin™ was manufactured under GMP conditions, first at Wyss Zurich and thereafter at CUTISS in Schlieren, Switzerland.

This publication adds to the growing body of clinical evidence supporting denovoSkin™ as a personalized, bio-engineered dermo-epidermal skin graft for the treatment of acute and elective full-thickness skin defects.

The paper, published in the Journal of Tissue Engineering, is titled “Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial” and can be found online here.

Our clinical development pipeline is available here.