RenovaCare Beginning Clinical Trial at Four U.S. Burn Centers

RenovaCare Inc. is initiating a clinical trial at four burn centers in the United States. This follows the company’s Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA).
 
The clinical trial, designated CELLMIST-1, utilizes the company’s 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 marks a milestone in the company’s clinical program—the first controlled clinical study and the first step on the Premarket Approval (PMA) regulatory pathway towards U.S. marketing,” stated Dr. Robin Robinson, RenovaCare’s chief scientific officer.
 
The CELLMIST-1 clinical study has begun enrollment at the Burn Center of MedStar Washington Hospital Center (Washington D.C.). Other clinical study sites will include the UMC Burn Center at University Medical Center New Orleans (New Orleans, La.), University of Florida Health Shands Burn Center (Gainesville, Fla.), and the Regional Burn Center, Tampa General Hospital, University of South Florida Medical Center (Tampa, Fla.).
 
RenovaCare, Inc. is developing new-generation autologous (self-donated) cell therapies for the regeneration of human tissues. The company’s initial product under development targets the body’s largest organ, the skin. The company’s flagship technology, the CellMist System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist System facilitates rapid healing of wounds or other tissue abnormalities when applied topically as a gentle mist of cells using the patented RenovaCare SkinGun. The company’s SkinGun is used to spray a liquid suspension of a patient’s stem cells—the CellMist Suspension—onto wounds.
 
Development and commercialization of next-generation biomedical technologies and devices for addressing unmet medical needs is taking place at the RenovaCare Research and Development Innovation Center, located at StemCell Systems GmbH in Berlin, Germany. StemCell Systems is a biomedical engineering and prototyping company. The Innovation Center houses dedicated RenovaCare cell biology laboratories; additional engineering, fabrication, prototyping and performance testing facilities; and product design studios for medical devices and biomedical products. Experienced contract bioengineers, cell biologists, and support staff work under the direction of a team of MD-PhDs who are experts in regenerative medicine, new product development, and clinical translation.
 
RenovaCare is currently developing its CellMist System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars.