More than three
million United States adults suffer from venous ulcers, suggested a new report from THE SAGE GROUP. The cost of venous
disease represents a significant burden on patients and the U.S.
economy, with venous ulcers alone costing at least $21 billion annually.
Apligraf® - an FDA-approved, bioengineered living-cell therapy from
Organogenesis Inc. - has become the first wound-healing therapy to
demonstrate a significant change in the genomic profile of a treated
non-healing wound, suggested a new research published in the
peer-reviewed journal Science Translational Medicine
‘The application of Apligraf in conjunction with compression therapy altered specific molecular and cellular responses in the wound environment, converting the chronic wound profile to resemble an acute, healing wound profile.’
analysis from a multidisciplinary research team at the University of
Miami, titled "A bioengineered living cell construct activates an acute
wound healing response in venous leg ulcers," provides new insight on
what happens to a wound's genomic profile when Apligraf is applied to a
chronic venous leg ulcer (VLU), when compared to standard care with
compression therapy alone.
The analysis found that the application of
Apligraf in conjunction with compression therapy altered specific
molecular and cellular responses in the wound environment, converting
the chronic wound profile to resemble an acute, 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," said Marjana Tomic-Canic, Director of the Wound Healing
and Regenerative Medicine Research Program at the University of Miami.
"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."
The research consisted of a prospective, randomized, controlled
clinical trial that analyzed VLUs with less than 40% area
reduction after four weeks of treatment with standard care with
compression therapy. Biopsies were performed at the edge of the wound to
define the profile of the non-healing VLUs.
Patients were then
randomized into: a) a group receiving treatment with standard of care
therapy alone; and b) a group receiving treatment with Apligraf and
standard of care therapy. At Day 7 after Apligraf was applied, biopsies
were performed again to assess changes in the ulcer profile. Results of
the biopsies from this study were compared to the existing data set for
biopsies taken from acute, healing wounds.
The study concluded that, for the group treated with both Apligraf
and standard of care therapy, Apligraf modulated inflammatory and growth
factor signaling and activated keratinocytes at the wound edge; thus
successfully shifting the wound environment from a chronic, non-healing
ulcer microenvironment to a distinctive healing milieu resembling that
of an acute, healing wound.
"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," said Gary S. Gillheeney, Sr., President & CEO of
Organogenesis. "This study provides valuable information to researchers
and clinicians working to promote healing in chronic wounds."