StrataGraft (burn healing agent)

2021: Announcement of a burn healing agent made from human skin cells

In mid-June 2021, the biopharmaceutical company Mallinckrodt introduced a human skin cell StrataGraft agent for the treatment of adults with thermal burns. The agent includes allogeneic cultured keratinocytes and dermal fibroblasts suspended in mouse collagen and can be used in deep burns that typically require surgical treatment.

The effectiveness of the agent is confirmed by the results of a phase 3 reference clinical trial, STRATA2016, in which StrataGraft were used in patients with acute thermal burns covering 3-37% of the total body surface area. The results, published in the journal Burns, showed that when treating StrataGraft, the area of ​ ​ burn wounds requiring autotransplantation after 3 months decreased significantly.

StrataGraft (burn healing agent)

Autotransplantation is considered the modern standard of treatment for deep burns - complex skin injuries, in which the lesion extends to the entire epidermis (the outermost layer of the skin) and reaches the lower part of the dermis (the deepest layer of the skin). Although autotransplantation is an effective method of closing burn wounds, it can lead to various complications, including pain, itching, increased risk of infection, and scarring. The StrataGraft agent is practically devoid of these disadvantages, and therefore more preferably for patients.

In a clinical trial, 96% of burn sites treated with StrataGraft did not require further autotransplantation. The difference in the area of the wounds which demanded transplantation between the StrataGraft group and control group made 98%, and the share of patients with the closed wounds in 3 months after processing of StrataGraft reached 86%. The most frequent adverse reactions were itching, blisters, hypertrophic scar and impaired healing.^[1]

Notes