Globe Newswire09.30.20
RenovaCare Inc., developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, announced U.S. Food and Drug Administration (FDA) conditional approval of its Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist System from donor skin and applied topically with the SkinGun spray device for treatment of burn wounds.
"The FDA conditional approval marks a significant milestone for RenovaCare and our technology for spraying an ultra-gentle mist of a patient’s own skin cells for the healing of burns and wounds. We are working to complete the FDA's technical requirements so that we may move forward with the next phase of development," stated Alan L. Rubino, the company's president and CEO.
The clinical trial protocol conditionally approved by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The company expects to conduct the clinical study at multiple U.S. burn centers.
"This achievement marks the culmination of our stem cell and spray technologies coupled to applied research and development resulting in a formal clinical evaluation of skin stem cells as a therapeutic to facilitate burn wound healing," stated RenovaCare Chief Scientific Officer Dr. Robin A. Robinson. "I am proud of our RenovaCare team and their dedication to our mission and commitment to provide effective and expedited patient healing and look forward to commencing this study as quickly as possible."
"The FDA conditional approval marks a significant milestone for RenovaCare and our technology for spraying an ultra-gentle mist of a patient’s own skin cells for the healing of burns and wounds. We are working to complete the FDA's technical requirements so that we may move forward with the next phase of development," stated Alan L. Rubino, the company's president and CEO.
The clinical trial protocol conditionally approved by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The company expects to conduct the clinical study at multiple U.S. burn centers.
"This achievement marks the culmination of our stem cell and spray technologies coupled to applied research and development resulting in a formal clinical evaluation of skin stem cells as a therapeutic to facilitate burn wound healing," stated RenovaCare Chief Scientific Officer Dr. Robin A. Robinson. "I am proud of our RenovaCare team and their dedication to our mission and commitment to provide effective and expedited patient healing and look forward to commencing this study as quickly as possible."
