New Randomized Trial Shows ReCell Heals Donor Sites Faster

Deploying a suspension of cells generated from a ReCell medical device onto a skin donor site can speed up healing by 30.7 percent and deliver a superior final outcome, according to the results of a randomized controlled trial involving 106 patients who received skin grafts, Avita Medical said.
 
Avita, a regenerative medicine company focused on the treatment of wounds and skin defects, said the findings reported in the British Journal of Surgery (BJS) further supported its growing data package around its ReCell autologous cell harvesting device. This is the third randomized controlled trial announced in recent months: in May, the company presented data from two trials conducted at leading burns centers across the United States, including successful results from its pivotal trial needed for premarket approval with the U.S. Food and Drug Administration.
 
“We are excited about these results, as together, the data show that ReCell can be deployed both to reduce patient trauma, and to help patients heal faster,” said Avita CEO Mike Perry. “Our pivotal trial in the U.S. showed how ReCell allowed doctors to successfully treat burns using about 30 percent less donor skin. Now, in China, surgeons have shown that the donor site itself can heal some 30 percent faster when treated with Regenerative Epithelial Suspension made using the ReCell device. Demonstration of clinical benefit for treatment of burn injuries and treatment of donor sites further substantiates the key, versatile role for ReCell in burn care.”
 
The BJS paper—”Randomized clinical trial of autologous skin cell suspension for accelerating re-epithelialization of split-thickness donor sites”—was based on work by a team of burns and plastic surgeons at the Sun Yat Sen University Hospital, in Guangzhou, China, led by Prof. J. Zhu. The Chinese investigators wished to explore whether donor sites for skin grafts healed faster and better if ReCell was deployed alongside the main standard of care, which was a hydrocolloid dressing. Over a period of some 18 months, a total of 106 patients were recruited, with 53 in either the Control or ReCell-treated groups, amongst patients who presented at the hospital requiring split-thickness skin grafts.
 
The researchers evaluated how long it took for the epithelial layer of skin to restore on donor sites, with and without ReCell, a device that allows surgeons to deliver a suspension of skin cells to aid tissue repair and skin regeneration. They reported that the median time to complete re-epithelialization was nine days in the ReCell-treated group, compared with 13 days in the control group, a 30.7 percent difference that was a statistically significant (p < 0.001).
 
The authors said both patients and independent observers evaluated that the donor sites treated with autologous skin cell suspension displayed better physical attributes and patients were more satisfied with healing quality. Early and rapid re-epithelialization is thought to enhance wound healing, improve long-term aesthetic appearance, and deliver “appropriate pigmentation,” they said.
 
“The autologous skin cell suspension is produced quickly and is available immediately for wound application,” the investigators said. “This study suggests that its use [on] skin graft donor [sites] should promote healing and improve long-term aesthetic results.”
 
Avita said the positive data reflected the growing interest about ReCell amongst burns surgeons in China. In an earlier trial, Zhu’s team in Guangzhou showed successful healing of chronic wounds with the ReCell device.
 
Avita’s patented and proprietary collection and application technology provides treatment solutions derived from the regenerative properties of a patient’s own skin. Its medical devices work by preparing a regenerative epithelial suspension (RES), an autologous suspension comprised of the patient’s own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
 
In all countries outside of Europe, the company’s portfolio is marketed under the ReCell brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. ReCell is registered in Australia, and has been cleared by Chinese regulators. In the United States, ReCell is an investigational device limited by federal law to investigational and compassionate use.
 
In Europe, Avita’s portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. ReCell is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell is tailored for aesthetic applications including the restoration of pigmentation.