The trial will assess the safety and feasibility of the system to treat burn wounds
The US Food and Drug Administration (FDA) has approved RenovaCare’s investigational device exemption (IDE) application to begin the clinical trial of the SkinGun and CellMist system.
The approval allows RenovaCare to carry out a study to assess the safety and feasibility of the system to treat burn wounds using skin cells secured directly from the burn patient.
RenovaCare chief scientific officer Dr Robin Robinson said: “This marks the first FDA approval of a RenovaCare-sponsored regulatory submission, which is an important inflection point for our company and all our stakeholders.
“This approval enables RenovaCare to demonstrate how its CellMist™ System and Electronic SkinGun spray device can deliver a regenerative cell therapy to treat burn wounds in a controlled, definitive care setting.”
RenovaCare will recruit 14 adult burn subjects with partial-thickness second degree thermal burn wounds in an open-label and single-arm clinical study.
The company intends to carry out the clinical study at four US burn centres over 12 months.
RenovaCare president and CEO Dr Kaiyo said: “Acute severe burn wounds are often times debilitating. Severe burns result in symptoms that impact quality of life which commonly persist for years, despite following current standard-of-care medical treatment.
“Today, the FDA’s approval of our IDE application is a truly momentous occasion for RenovaCare and affirms our mission of delivering breakthrough cell therapy for burn patients around the world.”
According to the company, the SkinGun and CellMist system has already been used to treat more than 70 patients with various types of burns in investigator-initiated clinical case studies.
The company has developed the SkinGun and CellMist system as a potential alternative to skin grafting and other treatment options such as in vitro cultured skin epithelial cells, which need a specialised and costly external laboratory
At the end of 2019, RenovaCare secured a patent for its novel SkinGun spray device for the spraying of different tissues and cells.