Clinical Evaluation of NIKS-Based Bioengineered Skin Substitute Tissue in Complex Skin Defects: Phase I/IIa Clinical Trial Results

Abstract

A phase I/IIa clinical trial found that NIKS-based BSS was well tolerated and comparable to cadaver allograft in the ability to prepare full-thickness complex skin defects prior to autografting. There were no deaths and no adverse events (AE) associated with this BSS. Exposure of the study subjects to the skin substitute tissue did not elicit detectable immune responses. Notably, this tissue remained viable and adherent in the wound bed for at least 7 days.