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Positive Results Reported for StrataGraft Skin Tissue in Patients With Severe Burns
Positive results have been reported from a mid-stage proof-of-concept trial of StrataGraft skin tissue in patients with deep partial-thickness burns. The study’s goal was to assess the product’s safety and efficacy, as measured by the degree and durability of wound closure.
Twenty-eight patients received a single randomized treatment of StrataGraft tissue on one burn site and an autograft on a comparator site. Of these patients, 27 (96%) had complete wound closure of their StrataGraft-treated site at the 3-month primary endpoint.
Currently, patients who incur severe burns that are not expected to heal on their own undergo autografting, a surgical procedure involving the harvesting and transplantation of the patient’s own skin from an uninjured donor site to the trauma site. Although this regimen has been the standard of care for decades, donor sites are painful; have a risk of infection until healed; and can remain fragile for a prolonged period.
StrataGraft is a human cellular therapeutic being developed as a treatment for severe burns. According to the product’s developer (Stratatech Corporation), it was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers, and is cryopreserved to sustain a long shelf life. The biologically active tissue has a barrier function comparable with that of intact human skin. In addition to providing immediate wound coverage to minimize fluid loss, the viable cells of StrataGraft tissue express numerous antimicrobial peptides, growth factors, and cytokines, which facilitate regeneration of the patient’s own skin. StrataGraft tissue was granted an “orphan product” designation in 2012 by the FDA for the treatment of partial and full-thickness burns.
The new clinical trial was designed to assess the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns without the need for autografting. Each patient had two comparable areas identified and randomized to receive autologous skin grafts or StrataGraft skin tissue. In this dose-escalation study, three cohorts of 10 patients each received a single application of StrataGraft skin tissue immediately after surgical excision of nonviable tissue. Cohort 1 received up to 220 cm2 of refrigerated StrataGraft skin tissue; cohort 2 received up to 440 cm2 of refrigerated StrataGraft tissue; and cohort 3 received up to 440 cm2 of cryopreserved StrataGraft tissue. The study’s primary endpoints were wound closure after 3 months and the percentage of the initial StrataGraft treatment site requiring autografting by day 28. Additional assessments included wound and donor site cosmesis, pain at donor sites, immunological responses to StrataGraft skin tissue, and the persistence of allogeneic DNA.
The final patient assessment was completed in October 2014. The key findings are as follows:
- No study sites treated with StrataGraft skin tissue required autografting by day 28.
- Twenty-seven of the 28 per-protocol subjects for whom 3-month data were available had complete wound closure of both the StrataGraft-treated and autograft study sites at the 3-month study session. The 28th subject exhibited 85% re-epithelialization at 3 months.
- StrataGraft DNA was undetectable in all assessed patients at 3 months, confirming that the patient’s skin had been regenerated with their own cells.
- There was no evidence of infection at any of the StrataGraft-treated sites.
- Cosmesis assessments by clinicians of StrataGraft and autograft study sites were comparable.
The American Burn Association estimates that 1.1 million people incur burns annually in the U.S. Of these individuals, approximately 40,000 are hospitalized for treatment, and 30,000 are admitted to specialized burn centers.
Source: Stratatech Corporation; March 10, 2015.