In an important milestone for Avita Medical the first US-based treatment of a burns victim with ReCell under the approved FDA protocol was conducted at Wake Forest University Baptist Medical Burn Center in Winston-Salem, North Carolina.
ReCell is a stand-alone, rapid cell harvesting device that enables surgeons to treat skin defects using the patient’s own cells.
The patient presented with burns on both arms; burn sites were arbitrarily labelled ‘A’ and ‘B’ per protocol. Through the protocol’s blinded randomisation process one site was assigned treatment with ReCell, the other served as a control and was treated with split thickness skin graft, the current standard of care.
On seven-day follow-up the patient had excellent results: the ReCell graft site had 100% take and was fully re-epithelialised (i.e., the treated wound was completely covered with new skin with no open areas or blisters). In contrast, the control site had 75-80% take with 20-25% of the area having unhealed open interstices.
Similarly, the ReCell donor site was 100% closed and fully reepithelialised
whereas the control traditional graft donor site on the thigh remained open and
slightly oozy with numerous bleeding spots. Critically, in self-reporting of pain, the patient reported 0/10 pain at the ReCell site and 10/10 pain at the traditional control site.
Dr William Dolphin, CEO of Avita Medical, said: “We are very pleased but not surprised by the excellent outcome. The ReCell Spray-On-Skin technology offers great benefits to the patient and clinicians and has the potential to deliver significant cost savings to the healthcare system.”
Under the revised and approved FDA protocol ReCell Spray-On-Skin and the AFIRM defense forces sponsored study.
Subsequent to FDA trial approval in December 2009, Avita has worked with each of the participating investigational sites to obtain Institutional Review Board (IRB) approval for the conduct of the study. This has occurred on a site-by-site basis and involves a separate IRB submission for each site.
Each institute’s IRB ethics committee for research involving human subjects typically meets on a monthly or 6-weekly basis and must review and approve the research protocol, all patient consent forms and ensure proper patient safety. They must also ensure that the study complies with all regulatory requirements.
Once IRB approval was achieved, Avita Medical entered into negotiations with the business unit at each institute and negotiated final contractual terms including institutional overheads, facility fees and payment structure. Enrolment cannot commence until IRB approval and contracts with each institute business office are signed.
Dr Wiliam added: “It is a long process and can be quite frustrating. Because the field of regenerative medicine and cell-based therapies is so new, the FDA and ethical review boards are conservative in their approvals. This translates to longer lead times. None-theless, the entire process has now been completed at five key investigational sites and we have achieved the substantial US milestone of commenced enrolment and application of ReCell.”
Avita Medical is a publicly listed, global medical technology company that develops and distributes regenerative and tissue-engineered products for the treatment of a wide range of wounds, scars and skin defects.