Organogenesis Inc. said yesterday that its wound-healing cell therapy Apligraf is the 1st of its kind to significantly change the genomic profile of a treated chronic wound. The claim was supported by new research done at the University of Miami and published in the journal Science Translational Medicine.
The team applied Apligraf to a chronic venous leg ulcer and studied the wound’s genomic profile, comparing it to compression therapy, which is a standard method of care. The study showed that using the cell therapy in combination with compression therapy changed the wound’s microenvironment and altered the chronic wound’s genomic profile to a healing wound profile.
“This is the first time this type of detailed gene expression analysis has been conducted to evaluate the response to a wound healing modality,” Marjana Tomic-Canic, from the University of Miami, said. “Our findings show that Apligraf can shift the gene expression profile of a chronic, non-healing ulcer to resemble a profile similar to that of an acute, healing wound. This is important as we now can use this as a guiding tool to understand healing of a chronic wound and mechanisms by which therapies can work.”
Patients in the trial were randomized into 2 groups – a control arm received treatment with compression therapy and their counterparts received Apligraf in combination with compression therapy. The researchers performed biopsies at the edge of patients’ wounds to better understand the chronic wound genomic profiles of each patient.
A week after patients received treatment, biopsies were taken again to measure any changes in the ulcer’s profile. Results from the biopsies were compared to an data set of biopsies taken from healing wounds. The cohort treated with both Apligraf and compression therapy had modulated inflammatory and growth factor signaling at the edge of their wounds.
“The acceptance of this groundbreaking research into the prestigious Science Translational Medicine journal underscores our company’s commitment to developing safe, effective, and evidence-based advanced wound care products for clinicians,” Organogenesis president & CEO Gary Gillheeney, Sr., said in prepared remarks. “This study provides valuable information to researchers and clinicians working to promote healing in chronic wounds.”
Apligraf is approved by the FDA for the treatment of venous leg ulcer and diabetic foot ulcers that have lasted longer than 1 month and have not responded to standard therapy. The cell therapy is composed of a layer of differentiated keratinocytes and fibroblasts in a collagen matrix.