Pediatric Compassionate use of denovoSkin™, a Novel, Autologous, Engineered, Hydrogel-Based Skin Graft with Keratinocytes and Fibroblasts

The development of an autologous, full-thickness skin replacement remains the holy grail for the treatment of full thickness skin loss from burns, wounds, and trauma. With massive burn injury and limited donor-site, cultured epidermal autografts (CEAs) can be lifesaving, however they have significant limitations. Furthermore, reconstruction in such patients is challenging. We describe the compassionate use of an autologous, engineered, hydrogel skin graft with keratinocytes and fibroblasts (EHSG-KF), in the treatment of a pediatric patient with massive burn injury. A compassionate use exemption was obtained from the U.S. Food and Drug Administration allowing for up to 3 separate treatments using an EHSG-KF for a 3-year-old patient with a 90% TBSA burn. Grafts were based on plastically compressed collagen type I hydrogels with incorporated keratinocytes and fibroblasts. We retrospectively review our experience with two separate applications and early outcomes. A 2x2cm split thickness skin graft was harvested and shipped internationally for processing. At the same time, contracture releases were performed, and dermal matrices were applied. EHSG-KF were then applied approximately 4 weeks after contracture release. In some areas, EHSG-KF was applied without a dermal matrix, immediately post debridement. Grafts were secured for 7 days with staples and covered with silver foam and tie over bolsters or circumferential gauze wrapping. Graft take was >95%. This novel EHSG-KF was relatively easy to handle, apply, and care for, similar to a traditional autologous FTSG. Engraftment rate was >95% and the resulting healed skin appears to be durable. Our impression has been extremely positive, particularly when compared to traditional CEAs. Additional trials in Europe using this particular EHSG-KF are ongoing.