The protocol for the clinical trial was recently presented at the Australian & New Zealand Burn Association Annual Scientific Meeting in Brisbane, Australia, by Dr. Anjana Bairagi, Honorary Research Fellow (Paediatric Surgery) at the Children’s Burns Centre at Lady Cilento Children’s Hospital. The current standard of care for children with partial-thickness burns is cleaning of the wound followed by a dressing application. Limitations of the standard of care include delay in healing of the burn injury, scarring, and pain. The clinical trial will include approximately 90 patients under 18 years old. Patients will be randomized into one of three groups and will be treated either with the RECELL System and Biobrane dressing, the Biobrane dressing alone, or standard care (silver impregnated silicone lined dressing). The primary endpoint will be days to re-epithelization of the burn injury. Secondary endpoints include pain, patient satisfaction and scarring.
The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. A small skin sample is enzymatically and mechanically processed in the RECELL System at the point of care to isolate the skin cells to produce a suspension of Spray-On Skin Cells. The regenerative cell suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. The suspension can be sprayed directly on a second degree burn or with an expanded skin graft on a third-degree burn, allowing for broad and even distribution of live cells across the entire wound bed. The RECELL System can be used to prepare enough suspension to treat a wound up to 80 times the size of the donor skin sample, so a skin sample approximately the size of a credit card can be used to treat a wound that covers an adult patient’s entire back. Randomized, controlled trials have demonstrated that treatment of acute burn wounds with the RECELL System requires substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical’s first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration in September 2018. The RECELL System indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System produces Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 7,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.
In international markets outside of Europe, the company's portfolio is marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia, and CFDA-cleared in China.
In Europe, AVITA Medical's portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. The RECELL Autologous Cell Harvesting Device is designed for the treatment of burns and plastic reconstructive procedures; REGENERCELL Autologous Cell Harvesting Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL Autologous Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation.