StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat), created by StrataTech Corporation, a Mallinckrodt company, has been FDA-approved for the treatment of deep partial-thickness thermal burns in adults. It gives burn surgeons another treatment option, one which showed a reduction in the need for harvesting skin (autografting) in clinical trials. Please see Important Safety Information below.
Each year, approximately 40,000 patients in the United States require hospitalization for the treatment of severe burns. To date, standard treatment involves the surgical harvesting of healthy skin from an uninjured area on the patient. That skin would be transplanted to the burned area, leaving the patient with both the burn wound and a secondary wound where the skin was removed.
StrataGraft, on the other hand, is a bioengineered product with both dermal and epidermal layers that deliver viable cells to support the body’s own ability to heal. It is placed by a surgeon in lieu of harvested skin onto a surgically prepared wound bed. It does not permanently engraft but is replaced over time by the patient’s own cells.1
StrataGraft had been in development for over 20 years, with technical support and $122 million of funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR), formally the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS).
BARDA expressed interest in StrataGraft as a medical countermeasure in response to large-scale burn incidents. In addition to ongoing burn treatment measures, StrataGraft could be deployed quickly by BARDA to care sites should a mass casualty thermal burn event occur.
The technology was developed by University of Wisconsin-Madison Professor, Lynn Allen-Hoffmann, PhD. She founded StrataTech Corporation in 2000, which was acquired by Mallinckrodt Pharmaceuticals in 2016. StrataGraft was approved by the U.S. Food and Drug Administration in 2021.
Mallinckrodt is currently conducting a study in full-thickness thermal burns in adults and also planning to initiate a study investigating StrataGraft as a deep partial-thickness burn treatment option in pediatric patients. StrataGraft is not yet approved for these indications, and the safety and efficacy have not been evaluated by the FDA. These therapies align with the Ireland-based company’s mission to develop and provide solutions for underserved patients with severe and critical conditions.
IMPORTANT SAFETY INFORMATION
- Do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin.
Warnings and Precautions
- StrataGraft contains glycerin. Avoid glycerin in patients with known sensitivity (irritant reaction) to glycerin.
- Severe hypersensitivity reactions may occur. Monitor for both early and late symptoms and signs of hypersensitivity reaction following StrataGraft application, and treat according to standard medical practice.
- StrataGraft contains cells from human donors and may transmit infectious diseases or infectious agents, eg, viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD or variant CJD]).
StrataGraft is a xenotransplantation product because of an historic exposure of the keratinocyte cells to well-characterized mouse cells. The cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are not used in the manufacture of StrataGraft; however, these measures do not entirely eliminate the risk of transmitting infectious diseases and disease agents.
Transmission of infectious diseases or agents by StrataGraft has not been reported.
- Because StrataGraft is a xenotransplantation product, StrataGraft recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans.
- The most common adverse reactions (incidence ≥2%) were itching (pruritus), blisters, hypertrophic scar, and impaired healing. Other adverse events reported are included in the full Prescribing Information.
- The safety and effectiveness of StrataGraft in pediatric patients (<18 years) have not been established.
Please see full Prescribing Information
StrataGraft® is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2022 Mallinckrodt. US-2200825 09/22
 StrataGraft Package Insert. Stratatech Corporation; 2021.
 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed August 16, 2022.
 Girard D, Laverdet B, Buhe V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82. doi:10.1089/ten.TEB.2016.0195.
 Department of Pathology and Laboratory Medicine. 2022. B. Lynn Allen-Hoffmann receives Chancellor’s Entrepreneurial Achievement Award. [online] Available at: <https://pathology.wisc.edu/2022/03/25/b-lynn-allen-hoffmann-receives-chancellors-entrepreneurial-achievement-award/> [Accessed 16 August 2022].