RenovaCare, Inc. announced that its investigational device exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This approval enables the company to conduct a clinical trial to evaluate the safety and feasibility of its SkinGun and CellMist System for the treatment of burn wounds using skin cells obtained directly from the burn patient. The clinical trial protocol is an open-label, single-arm clinical study that will enroll 14 adult burn subjects with partial-thickness second degree thermal burn wounds.
The company expects to conduct the clinical study at four U.S. burn centers over twelve months. Spraying Cells onto Burns and Wounds: to date, over 70 patients with various types of burns have been treated in investigator initiated clinical case studies utilizing the technology underlying the company's SkinGun and CellMist System, which the company has developed as a potential alternative to skin grafting and other treatment options, such as in vitro cultured skin epithelial cells that require a specialized and expensive external laboratory. Clinical outcomes of these early experimental studies have been peer-reviewed and published in several medical journals, including Burns and Annals of Plastic Surgery.
In late 2019, the company was issued a patent allowing the company's novel SkinGun spray device to spray a variety of tissues and cells, thus opening the door for its potential application in the regeneration of other tissues, beyond skin.