Cellularized Skin Scaffold Treats Deep Partial-Thickness Burns

The Stratatech (Madison, WI, USA) StrataGraft is made of human keratinocytes and dermal fibroblasts that are grown together to form a bi-layered rectangular sheet, mimicking natural human skin with both inner dermis-like and outer epidermis-like layers. The cellular construct is meshed (dotted with slits), similar to an autograft prepared for surgical use, and is applied to the burn wound by suturing, stapling, or with an adhesive to provide initial coverage during the healing process.

StrataGraft is produced using patented Near-Diploid Immortal Keratinocytes (NIKS) cells and human dermal fibroblasts, all of which have been thoroughly characterized, helping to ensure delivery of tissue that is virus-free, non-tumorigenic, and consistent genetically batch to batch. NIKS keratinocyte progenitor cells also produce growth factors that stimulate regeneration of the patient’s own skin cells, while evoking a very limited immune response.

“We are hopeful that the presence of our tissue will enable the patient’s own tissue to heal underneath over time without taking that autograft. So we are going to be reducing surgical procedures and eliminating a lot of pain and hopefully promoting wound healing,” said Lynn Allen-Hoffmann, MD, PhD, founder of Stratatech, which is now part of Mallinckrodt ( Staines-upon-Thames, United Kingdom). “We can make it, stockpile or store it for a period of time, and then get it out to clinical sites as its needed.”

Deep partial-thickness burns affect all layers of the skin, and may cause damage down to underlying muscles. These burns carry severe risk for complications, such as infections, blood loss and shock, which could lead to organ failure or death. The current standard of care for severe burns is skin-grafting, or autografting, which is the surgical harvest of healthy skin from an uninjured site on the patient’s body followed by transplant to the wound. It results in a donor site wound that requires medical management of pain, and may result in infection and/or scarring.

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Stratatech
Mallinckrodt