RenovaCare, Inc. Clinical Trial to Start At U.S. Burn Centers
June 07, 2021 at 08:30 am EDT
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RenovaCare, Inc. announced that it is initiating a clinical trial at four burn centers in the United States. This follows the Company’s recent Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). The clinical trial, designated CELLMIST-1, utilizes electronic SkinGun™ spray device and CellMist™ System to render the skin and stem cells uniquely from both the epidermal and dermal layers of the patient’s own skin tissue and then topically spray these cells onto burn wounds to facilitate wound healing. This clinical study will evaluate the safety and feasibility of the Company’s autologous skin stem cell therapy for the treatment of deep second-degree, partial-thickness burn wounds in adults. The CELLMIST-1 clinical study is slated to start enrollment this week at the Burn Center of MedStar Washington Hospital Center (Washington D.C.). In coming weeks, clinical study sites at UMC Burn Center at University Medical Center New Orleans (New Orleans, LA), University of Florida Health Shands Burn Center (Gainesville, FL), and the Regional Burn Center, Tampa General Hospital, University of South Florida Medical Center (Tampa, FL) will open for enrollment.
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.