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FDA approves "artificial skin", new option for burn transplantation

 Last Update: 2021-08-10
 Source: Internet
 Author: User

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On June 15, local time, the U.

It is reported that StrataGraft is one of the first products designated as Regenerative Medicine Advanced Therapy (RMAT) by the FDA in accordance with the 21st Century Cures Act

Burns are a global public health problem.

The source of skin grafts is often the patient's own healthy skin, which is tantamount to "removing the east wall and replenishing the west wall", so "artificial skin" is a very potential substitute

StrataGraft is composed of keratinocytes and dermal fibroblasts.

According to data published by Mallinckrodt, in the key phase 3 clinical trial STRATA2016, 71 patients with a deep burn area of 3%-37% were treated by StrataGraft, and 68 (96%) of the burn site did not require autologous skin grafting

In terms of adverse reactions, StrataGraft has the same performance as autologous transplantation.

"Severe burns are a very difficult injury, and the goal of burn management is to help patients restore their skin to the best possible condition while improving the overall quality of life of patients," said Dr.

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