Avita Medical Ltd. today announced that doctors at a leading US military hospital have started a trial to investigate how the company’s ReCell device can be used to treat traumatic wounds suffered by civilians and wounded military personnel.
ReCell is a unique technology that enables a clinician to rapidly create, at point of care in approximately 30 minutes, Regenerative Epithelial Suspension (RES) using a small sample of the patient’s skin. RES is an autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin. RES™ has a broad range of applications and can be used to restart healing in unresponsive wounds, to repair burns using less donor skin yet with improved functional and aesthetic outcomes.
The first patient has been treated in the study, which is funded through a US Department of Defense research program and taking place at the Walter Reed National Military Medical Center in Bethesda, Maryland. Avita Medical will play an advisory supporting role in the trial.
Researchers, led by principal investigator Dr. J. Peter Rubin, M.D., Chair of the Department of Plastic Surgery at the McGowan Institute for Regenerative Medicine at the University of Pittsburgh and investigator for the Armed Forces Institute of Regenerative Medicine (AFIRM), hope to recruit up to 20 patients in the randomized, within-patient controlled, feasibility study.
The investigator-initiated trial is aimed at evaluating whether ReCell treatment combined with widened split-thickness skin grafts is more effective in treating full-thickness traumatic wounds than conventional skin grafts. Outcomes for the area treated with Regenerative Epithelial Suspension (RES) produced using the ReCell device will be compared to outcomes of another area on the same patient treated with only conventional meshed autografting.
“When treating injuries associated with severe trauma, physicians are often limited in choice of donor sites for skin grafts, and so there is a real need for an acceptable alternative to conventional full and partial thickness skin autografting,” said Andrew Quick, Avita Medical VP Research & Technology.
Previous use of ReCell® at Walter Reed, under compassionate use dispensations granted by the FDA, has included treatment of soldiers wounded in Afghanistan and Iraq. Avita Medical believes the device, being fully portable, battery-powered, and needing only ambient storage temperatures, is well suited for deployment in field hospitals.
Source: Avita Medical press release, adapted. ReCell® and Regenerative Epithelial Suspension (RES™) are registered, protected terms of Avita Medical.