RenovaCare, Inc Provides Update on Clinical Trial for the SkinGun™ and CellMist™ System for Wound Healing
July 22, 2021 at 08:30 am EDT
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RenovaCare, Inc. provided an update on its clinical trial evaluating the safety and feasibility of the SkinGun™ and CellMist™ System to facilitate wound healing using skin cells obtained directly from the burn patient. Currently, CELLMIST 1, the clinical trial is activated and screening patients at its first burn center. The Company plans to expand its clinical trial to up to four centers in the United States. One site is currently under active negotiation; another candidate site has voluntarily withdrawn from consideration; a fourth clinical site has decided to defer continued negotiations to a later date. The CELLMIST 1 clinical study plans to enroll 14 human subjects between 18 and 65 years old that have partial-thickness, second-degree thermal burn wounds encompassing < 30% total body surface area. Each enrolled subject will be treated within seven days of the burn incident with their own skin cells isolated by the manual CellMist™ System and applied topically onto the burn wound(s) with the Electronic SkinGun™ spray device. Seven follow-up visits over 12 months will evaluate the safety and recovery of each subject.
RenovaCare, Inc. is a clinical-stage biotechnology company. The Company is focused on developing autologous (self-donated) stem cell therapies for the regeneration of human organs. The Company through its wholly owned subsidiary, RenovaCare Sciences Corp. is focusing on the research, development and commercialization of autologous (using a patientâs own cells) cellular therapies that can be used for medical and aesthetic applications. The Companyâs CellMist System is a cell isolation procedure that enzymatically renders stem cells from the patientâs own skin or other tissues. The resulting stem cell suspension is administered topically from the Companyâs novel solution sprayer device (the SkinGun) as a cell therapy for wounds including burns to facilitate healing. Its SkinGun spray device is an advanced technology, using a gentle positive-pressure air stream to spray the CellMist Solution onto wounds.