Science Translational Medicine on January 4 epublished randomized clinical trial results showing Organogenesis’s bioengineered living-cell wound-healing therapy demonstrated a significant change in the genomic profile of treated nonhealing venous leg ulcers (VLUs) compared with standard care.
The analysis from researchers at the University of Miami in Florida compared acute wound healing response in VLUs treated with the Canton, MA-based company’s Apligraf plus compression therapy and VLUs treated with compression alone.
Investigators applied the therapies to VLUs equal to or larger than 5 cm2 in area that had undergone less than 40% area reduction after four weeks of treatment with compression therapy.
They biopsied the edge of the wounds before Apligraf application and one week after application.
Apligraf, Food and Drug Administration-approved for treatment of VLUs and chronic diabetic foot ulcers, modulated inflammatory and growth factor signaling and activated keratinocytes at the wound edge, successfully shifting the wound microenvironment from that of a chronic nonhealing ulcer to a healing milieu resembling that of an acute healing wound.