October 25, 2018
AVITA Medical announced that the commencement of a randomized, controlled clinical study of the RECELL® Autologous Cell Harvesting Device (RECELL System) in the treatment of significant superficial partial- and mid-thickness pediatric burns, including scald injuries.
Avita Medical notes the clinical trial is being conducted by the Queensland University of Technology (QUT) in collaboration with the Pegg Leditschke Children’s Burns Centre at Lady Cilento Children’s Hospital in Brisbane, QLD. Treatment of children in the trial has commenced. The pediatric clinical trial is being led by Dr. Bronwyn Griffin, Child Health Research Centre, QUT, and Professor Roy Kimble, Roy M Kimble, Lady Cilento Children’s Hospital · Department of Paediatric Surgery.
The protocol for the clinical trial was presented last week at the Australian & New Zealand Burn Association Annual Scientific Meeting in Brisbane 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.