Mallinckrodt plc, a leading global specialty pharmaceutical company, announced the enrollment of the first patient in the company's phase 2 study assessing the safety, tolerability and efficacy of Stratagraft regenerative skin tissue as an alternative to autografting full-thickness complex skin defects.
"We are dedicated to providing regenerative medicine advanced therapies to patients with serious complex skin wounds, such as burns and other trauma," said Lynn Allen-Hoffmann, senior vice president, Regenerative Medicine at Mallinckrodt. "Our commitment to clinical investigation in full-thickness wounds underscores our focus on this important unmet medical need."
The phase 2 clinical study currently being investigated is titled "Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects." This range-finding study is designed to evaluate StrataGraft skin tissue as an alternative to autografting in promoting autologous tissue regeneration of the full-thickness component of complex skin defects resulting from acute traumatic skin loss (e.g., burn or degloving injuries). The study population will include patients with up to 49% total body surface area complex skin defects that include a full-thickness component.
Primary outcome measures will include the percent area of the StrataGraft treatment site requiring autografting by three months and wound closure of the treatment sites at three months. Targeted enrollment for this study is up to 20 patients 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. Study completion is expected by late 2018.
"We look forward to studying StrataGraft's potential to be a treatment option for patients with third-degree severe burns," said Steven Romano, M.D., chief scientific officer and executive vice president at Mallinckrodt. "We are pleased to enroll the first patient in this phase 2 clinical trial."
Full-thickness burns can also be referred to as third-degree burns. The standard of care for severe complex skin defects is the surgical harvesting of a sheet of healthy skin from an uninjured site on the patient and transplantation of this autologous skin graft to the injury once the wound is ready to receive an autograft. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of autologous skin tissue for grafting. These donor site wounds are extremely painful, prone to infection and scarring, and can themselves convert to full-thickness wounds that must then be managed to promote healing. In addition, the amount of healthy skin available for harvesting is frequently limited in large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is an urgent need for alternatives to donor site harvesting for treatment of severe burns and other complex skin defects
StrataGraft regenerative skin tissue, is a viable, full-thickness product being developed for severe burns and other complex skin defects that is not yet approved by the US Food and Drug Administration. 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.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.