Date: 2016-08-08
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results the Journal of Burn Care and Research
Company: Amarantus BioScience (USA – CA)
Product: Permaderm™ (Engineered Skin Substitute - ESS)
Action
mechanism: cell therapy. Engineered Skin Substitute (ESS) is a tissue-engineered skin prepared from autologous skin cells. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier. A non-GMP version ESS has been used in investigator-initiated and compassionate-use clinical settings in over 150 human subjects, primarily pediatric patients, for the treatment of severe burns up to 95% of total body surface area. The non-GMP version has also been used in the treatment of two patients with Giant Congenital Melanocytic Nevi (GCMN). Amarantus BioScience is evaluating opportunities to launch a pivotal clinical study with ESS in the areas of GCMN and pediatric severe burns once experience is gained in the adult severe burn setting. Amarantus is planning three distinct clinical development programs for ESS, all of which have the opportunity to gain rapid market approval in various orphan dermatologic conditions: - adult severe burns: initiating a 10-patient Phase 2 clinical development program with US Army study under CRADA at ISR and two additional leading civilian burn centers; ESS has received orphan drug designation from the FDA in the treatment of full-thickness burns covering over 50% TBSA.
- pediatric severe burns: evaluating Phase 3 development program designs with leading pediatric burn centers in the US;
- giant congenital melanocytic nevi (GCMN): evaluating pivotal Phase 3 development program designs with leading dermatology center(s) in the US.
Disease: full-thickness (dermal and epidermal layers of skin) life-threatening pediatric severe burns covering a total body surface area (TBSA) of 50% or greater
Therapeutic area: Dermatological diseases
Country:
Trial details:
Latest
news: * On August 8, 2016, Amarantus BioScience announced the publication of a 16-subject clinical study of Engineered Skin Substitute (ESS or "Permaderm™") in children with life-threatening severe burns. In this study, ESS was compared with the standard of care (split-thickness autograft "AG") for treating full-thickness (dermal and epidermal layers of skin) life-threatening pediatric severe burns covering a total body surface area (TBSA) of 50% or greater. Amarantus' wholly-owned subsidiary Cutanogen Corporation is pursuing the development of ESS towards regulatory approval for the treatment of life-threatening severe burns. The article entitled "Randomized, Paired-Site Comparison of Autologous Engineered Skin Substitutes and Split-Thickness Skin Graft for Closure of Extensive, Full-Thickness Burns" was published online in the July edition of the Journal of Burn Care and Research (Boyce, et al, 2016). Summary of the data: ESSs were prepared from split-thickness skin biopsies that were harvested from 16 pediatric burn patients who were enrolled in the IRB-approved study protocol;
ESSs and split-thickness autograft (AG) were applied to 15 subjects with full-thickness burns covering a mean of 76.9% TBSA;
Data consisted of photographs, tracings of donor skin and healed wounds, comparison of mortality with the National Burn Repository, correlation of TBSA closed wounds with TBSA full-thickness burn, frequencies of re-grafting, and immunoreactivity to the biopolymer scaffold;
One subject expired before ESS application, and 15 subjects received 2056 ESS grafts in total;
Correlation of % TBSA closed with ESSs with % TBSA full-thickness burn generated an R2 value of 0.65 (P < .001);
All 15 patients who received ESS survived;
Mortality in this ESS study was 6.25%, as compared to a 30.3% mortality rate for a comparable population from the National Burn Repository (P < .05), indicating that ESS may potentially reduce mortality by over 75% in this pediatric patient population;
These results indicate that autologous ESSs reduce mortality and requirements for donor skin harvesting, for grafting of full-thickness burns of greater than 50% TBSA.
