Cytori Therapeutics' Preclinical Data for the Treatment of Thermal Injury Published in the Journal Burns

Cytori Therapeutics, Inc.

announced today that preclinical and mechanistic data from its thermal injury study, performed with support from the Biomedical Advanced Research and Development Authority (BARDA), was published in the journal Burns, the official journal of the American Burn Association. The paper, entitled "Uncultured adipose-derived regenerative cells seeded in collagen scaffold improves dermal regeneration, enhancing early vascularization and structural organization following thermal burns" (Foubert P and coll. Published online: June 7, 2015 | DOI: 10.1016/j.burns.2015.05.004), is now available online [http://www.burnsjournal.com/article/S0305-4179(15)00132-1/abstract] and expands upon data presented earlier this year at the American Burn Association meeting. This paper reports that seeding Cytori Cell Therapy™ onto a widely used dermal substitute led to improvement in a number of parameters of healing of full thickness burns. Specifically, histopathological assessment demonstrated that the average depth of tissue within the wound was increased by approximately 2-fold in animals treated with Cytori Cell Therapy. This was associated with an increase in collagen deposition (1.7-fold), blood vessel density (1.5-fold), and mean vessel area (1.8-fold). Immunohistochemical analysis revealed an increase in the number of vessels expressing α-SMA (a marker for mature blood vessels) in animals treated with Cytori's Cell Therapy. Taken together, these results demonstrate that seeding Cytori Cell Therapy onto this scaffold promotes blood vessel maturation. Finally, the findings showed increased vascularity (1.5-fold) and cellularity (1.45-fold) of the dermal substitute itself. Use of skin substitutes provides an important option for care of patients with larger burns who cannot undergo definitive wound coverage in a single procedure. Such options will be particularly important following a mass casualty event that could overwhelm the capacity of specialist burn care centers. In this context a considerable portion of burn care will likely have to be provided by medical personnel without specialist burn surgery experience. "The data in this paper present a picture of accelerated maturation and organization of the tissue both within the wound and within the skin substitute," stated John Fraser, Cytori's Chief Scientist. "This ability to enhance healing supports a paradigm in which Cytori Cell Therapy is used to improve the quality and rate of wound healing and to reduce scarring when used in combination with a range of temporary and permanent skin substitutes thereby providing a means of improving burn care." This research, funded by a contract from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services, will be included in an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury. While there has been tremendous improvement in survival following severe thermal burn injury, hospitalization time, the development of scarring with pain and restricted range of motion, and other problems at both the injury and skin graft donor site remain significant issues. Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring. In addition, during a mass casualty event, availability of specialized burn centers for burn injuries may be limited and alternative therapeutic approaches will likely be required. Therefore, autologous Cytori's Cell Therapy represents a novel medical countermeasure not only to address these challenges but also to promote wound healing and tissue repair and improve casualty care.