RenovaCare, a company based in New York City, is seeking FDA approval for the SkinGun, a device to treat burns using a patient’s own stem cells. Significant portions of skin can be destroyed in burn injuries, meaning that regenerative therapy is required to restore or replace the injured tissue. Current treatments for burns involve skin grafting, where healthy skin is removed from the patient and then cultured in a laboratory, sometimes for several weeks, to grow larger sheets of cells. This delay in treatment can sometimes mean that the patient dies or develops complications such as infections.
The SkinGun has been developed with the aim of providing a rapid treatment for burns. The developers say that compared with skin grafting, a much smaller healthy skin sample can be converted into a regenerative treatment for an equivalent sized burn injury within just 2 hours. The treatment involves converting the harvested healthy skin into a solution containing the patient’s own regenerative stem cells, which is then sprayed onto the wound using the SkinGun device.
RenovaCare have reported that in their preliminary investigations, the device shows potential for the effective treatment of second degree burns. In some patients, the signs of skin healing have become apparent in as little as four days following treatment. So far, SkinGun has been used in a small number of burn patients as an investigational therapy.
The preliminary data point to the potential for reduced recovery times and greater levels of restoration of burnt tissue. However, the device will need to receive FDA approval before it becomes clinically available in the U.S. and clinical trials are needed to fully determine its efficacy and safety.
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