Avita Medical has received approval from the FDA to begin its US clinical trial for ReCell spray-on skin. The company claims it to be the first regenerative device enabling surgeons to treat burns, wounds and chronic skin defects using the patient’s own cells.
The company (as clinical cell culture) had previously commenced US trials in 2006, under a conditional approval as restrictive inclusion criteria patient recruitment was very low.
The company claims that changes to the newly approved protocol are substantial. It includes inclusion criteria allowing for an expanded wound size and body region, decrease in number of patients required to 106, decrease in patient follow-up period from 52 to 16 weeks, change in study endpoint from ‘time to 100% epithelialisation’ to a binomial assessment of ‘healed vs non-healed’ at 4 week follow-up, inclusion of superiority as well as non-inferiority outcomes, expanding post-study marketing claims.
The study is expected to yield a randomised, controlled, clinical comparison with the current standard of care in treating burn wounds. The company has appointed 10 clinical sites to participate in the trials and patient enrollment is anticipated to commence in early 2010. ReCell is currently cleared for sale in Australia, Europe, Canada and China.
The company said that part of the funding for the clinical trial is expected to come from the US Army with $1.45m grant to help develop regenerative medicine through the recently initiated Armed Forces Institute for Regenerative Medicine (AFIRM).
James Holmes, principle investigator for the trial, said: “ReCell is a transformational technology that will fundamentally change the way we treat burns and other wounds. When ReCell is approved for use in the US there is no doubt that it will save the lives of burn victims.”
