"This is an exciting milestone for StrataGraft, an investigational therapy that has the potential to revolutionize the standard of care for patients with severe burns," said
Autograft, the current standard of care, involves surgically removing a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound. Patients and clinicians report significant morbidity associated with the resulting donor site wounds, which are created during surgical removal of healthy skin. Donor site wounds are extremely painful, and can create risks of additional scarring and infection.
As a result of achieving this important enrollment milestone,
About the Phase 3 Clinical Trial
The open-label, controlled, randomized Phase 3 trial is evaluating the efficacy and safety of StrataGraft in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns. The trial is fully enrolled, and all study participants are ages 18 years and older with 3 to 49 percent total body surface area complex skin defects caused by thermal burns that contain intact dermal elements for which surgical excision and autografts are clinically indicated. The study design uses a within-patient control, with two sites randomly assigned to either standard of care (autograft) or StrataGraft treatment.
The trial's primary endpoints include:
For more information about the Phase 3 trial, visit www.clinicaltrials.gov (identifier: NCT03005106).
About StrataGraft Regenerative Skin Tissue
StrataGraft is an engineered, bilayer human skin substitute in development for patients with severe burns or other complex skin defects. Designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers, StrataGraft is being developed to be sutured, stapled or secured with an adhesive and initially provide coverage during the wound healing process. StrataGraft tissues are cryopreserved in order to deliver viable cells upon application.
StrataGraft regenerative skin tissue is produced using Near-Diploid Immortal Keratinocytes (NIKS®) cells and human dermal fibroblasts grown in accordance with Good Manufacturing Practice. StrataGraft tissue, as well as the NIKS cells and dermal fibroblasts, have been thoroughly characterized, helping to ensure consistent delivery of tissue that is virus-free, non-tumorigenic, and consistent genetically batch to batch. StrataGraft is an investigational product. The safety and effectiveness of StrataGraft have not yet been established by
In addition to the current Phase 3 trial, the company is evaluating StrataGraft in an ongoing Phase 2 trial for the treatment of adults with full-thickness complex skin defects resulting from burns and select other etiologies. There are also plans to study the safety and efficacy of StrataGraft in pediatric populations.
Funding and technical support for the development of StrataGraft regenerative skin tissue is being provided by the
About Serious Thermal Burns Containing Intact Dermal Elements
Serious thermal burns containing intact dermal elements, also known as deep partial-thickness burns, are complex skin injuries in which the entire epidermis and more than two thirds of the dermis are destroyed.
Current standard of care for severe complex skin wounds involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the autologous skin graft to the injury. 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. Donor site wounds are extremely painful and can create risks of additional scarring and infection. 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.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including expectations with regard to related clinical data and regulatory filings, its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical trial results; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of
Vice President, Investor Relations and IRO
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