A new study published in Journal Burn Care & Research
shows great promise for an engineered skin substitutes (ESS) to treat pediatric burn victims.
The study sponsor, Amarantus BioScience, has an orphan drug designation for the ESS to treat full-thickness burns covering over 50% total body surface area.
In the study, ESSs and split-thickness autograft were applied to 15 pediatric burn patients with full-thickness burns involving a mean of 76.9% total body surface area. A 16th
patient planned for the study died prior to the application.
Data consisted of photographs, tracings of donor skin and healed wounds, comparison of mortality with the National Burn Repository, correlation of total body surface area closed wounds with total body surface area full-thickness burn, frequencies of regrafting, and immunoreactivity to the biopolymer scaffold.
The ratio of closed wound to donor areas was 108.7 +/- 9.7 for ESSs compared with a maximum of 4.0 +/- 0.0 for autograft.
Mortality for enrolled subjects was 6.25% compared to 30.3% in the National Burn Repository (P
< .05). Engraftment was 83.5 +/- 2.0% for ESSs and 96.5 +/- 0.9% for autograft.
The study also noted that percentage total body surface area closed was 29.9 +/- 3.3% for ESSs, and 47.0 +/- 2.0 for autograft.
In a press release
, David Ahrenholz, MD, retired President of the American Burn Association said, "The publication of the human clinical data from the compassionate use study of ESS in the treatment of pediatric severe burns provides important detail surrounding the unprecedented results generated in the study, where all patients who survived long enough to receive ESS treatment ultimately survived, whereas the standard of care for the comparable patient population has a mortality rate in excess of 30%. "
Dr Ahrenholz added, "ESS has the potential to establish a new standard of care in the treatment of pediatric and adult severe burns, and I look forward to assisting the team at Amarantus in turning this clinical potential into medical reality."
About Engineered Skin Substitute (ESS)
Engineered Skin Substitute (ESS) is a tissue-engineered skin prepared from autologous (patient's own) skin cells. It is a combination of cultured epithelium with a collagen-dermal fibroblast implant that produces a skin substitute that contains both epidermal and dermal components.
Boyce ST, Simpson PS, Rieman MT, et al. Randomized, paired-site comparison of autologous engineered skin substitutes and split-thickness skin graft for closure of extensive, full-thickness burns. J Burn Care Res.
Published online ahead of print July 21, 2016. doi: 10.1097/BCR.0000000000000401