Type of information: Recruitment of the first patient
Announcement: recruitment of the first patient
Company: Mallinckrodt (UK)
Product: StrataGraft® regenerative skin tissue
Action mechanism: cell therapy. StrataGraft® regenerative skin tissue, is a viable, full-thickness product being developed for severe burns and other complex skin defects. It was designed to mimic natural human skin, with both dermal and fully- differentiated epidermal layers. Unlike first generation products, this resorbable tissue can be sutured or stapled and remains intact in the wound bed, providing critical barrier functionality during the wound healing process. StrataGraft® is produced using unmodified NIKS® cells grown under standard operating procedures. Because the continuous NIKS skin cell line has been thoroughly characterized, StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.
Disease: healing of excised full-thickness complex skin defects resulting from acute traumatic skin loss
Therapeutic area: Dermatological diseases
Trial details: The proposed study is designed as a phase II open-label, controlled, randomized, multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or multiple applications of StrataGraft® skin tissue as an alternative to autografting in promoting the healing of excised full-thickness complex skin defects resulting from acute traumatic skin loss. The proposed study population will include patients with up to 49% Total Body Surface Area (TBSA) complex skin defects including a full-thickness component. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single or multiple applications of StrataGraft® skin tissue, while also assessing the potential for StrataGraft® tissue to promote healing of the full-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 20 subjects with complex skin defects due to acute traumatic skin loss which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft® skin tissue. (NCT03005054)