Mallinckrodt plc has reported today that they have finished enrollment for the multi-center phase 3 clinical trial of their skin regenerating therapy, Stratagraft.
Current skin therapies rely on autografts, IE transplanting healthy skin from one area of the body to another. Stratagraft is a bioengineered, dual layer human skin substitute which is intended to either reduce the need for autografts, or replace them entirely in burn cases and other skin conditions.
The skin graft is produced using a combination of keratinocyte cells and human derman fibroblasts. Earlier clinical trials showed a high degree of tolerance and safety, and we suspect it is likely that approach will result in an a FDA approved treatment.