First ever compassionate use of denovoSkin delivers proof of principle
The patient had experienced a 95% total body surface area (TBSA) deep flame burn, and the use of a bio-engineered dermo-epidermal skin graft was therefore justified and permitted. A total of 1,626 cm2 of denovoSkin was transplanted onto the patient (approximately 20% TBSA).
This first large-scale application of denovoSkin reported:
- Ease of handling and application
- Excellent engraftment rates (80 - 90%) over dermal substitutes as well as over allodermal remnants
- Soft and solid, close to natural skin coverage, after a maturation process
As such, the reported case has delivered the clinical proof of principle that denovoSkin has the potential to help substantially in severe and acute burns.
It must be noted that, despite the promising skin grafting and healing process, the patient sadly died from multiple organ failure unrelated to the grafts. We believe that in the future, if denovoSkin can be applied sooner and in greater quantities in such disastrous cases, then it could lead to life-saving outcomes.
As the authors in the report conclude, the prospect of scaling up denovoSkin to provide more rapid response and treatment for major burns would be “a paradigm shift in the care of such patients”.
The full report case can be read online, see link below.
denovoSkin has Orphan Drug Designation for the treatment of partial and full thickness burn wounds by Swissmedic, EMA, and FDA. It is currently in Phase II clinical trials comparing denovoSkin to conventional split-thickness skin grafts.