Skin regeneration trial commences in China

Regenerative medicine company AVITA Medical has announced the commencement of a randomised, controlled clinical trial of its ReCell technology in the treatment of deep partial-thickness (second-degree) burns in China.

ReCell is a medical device designed to facilitate skin regeneration while reducing the amount of skin harvested at the time of surgery. Reduction in donor site skin requirements has important benefits from both clinical and health economic perspectives.

Funded by the Chinese National Health and Family Planning Commission, the controlled clinical trial will see burn patients treated with either standard of care, ReCell or one of two other treatments. The study is being led by Dr Dahai Hu of The First Affiliated Hospital of the Fourth Military Medical University (Xijing Hospital).

AVITA Medical also announced that it is collaborating with the Plastic Surgery Department of Peking Union Medical College Hospital (PUMCH), one of the most renowned hospitals in China, to establish a ReCell training centre based in Beijing. The training centre will help standardise protocol for the use of ReCell, train ReCell surgeons country-wide and encourage the expansion of the use of the treatment to hospitals across China. ReCell is being distributed in China by China Pharmaceutical Group Shanghai Medical Instrument, a wholly owned subsidiary of state-owned healthcare conglomerate Sinopharm.

“We are pleased to be working with such prestigious organisations as the China National Health and Planning Commission, PUMCH and Sinopharm,” said Dr Michael Perry, AVITA Medical’s chief executive officer. “Our initiatives within China are consistent with our evolving strategy of using data from controlled clinical trials and health economic studies to ensure that ReCell is effectively promoted and priced in all major markets.”

AVITA Medical has completed two US pivotal clinical trials in patients with severe burns, which will be used to support the planned launch of ReCell in the US and in other markets internationally. In addition, the company expects the commencement of additional clinical trials in burn patients in Australia and the UK this year, as well as two controlled clinical trials in the US in paediatric patients.

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