April 13, 2018
ReCell study results highlighs the potential benefits of the RECELL® Autologous Cell Harvesting Device in the treatment of deep partial-thickness (second-degree) facial burns.
The results showed excellent cosmetic outcomes when RECELL was used on deep partial-thickness facial burns, an injury for which treatment with standard of care often results in dyspigmentation and hypertrophic scarring at the seams of skin grafts. The results were presented by Nicholas Walker, MD, Wake Forest University School of Medicine, North Carolina, at the American Burn Association (ABA) 50th Annual Meeting in Chicago.
Avita Medical reports RECELL is an investigational medical device in the U.S. that is designed to enable medical professionals to produce, at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™) using a small sample of the patient’s own skin. The autologous suspension contains cells necessary to regenerate epidermis and provides a new way to achieve permanent closure in burns and other wounds 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.
Deep partial-thickness facial burns present a challenge in reconstructive surgery. Standard of care typically includes excision and allograft followed by split-thickness skin graft. Limitations of the current treatment regimen includes dyspigmentation at the sites of the skin grafts and hypertrophic scarring at the seams of the grafts, resulting in substantial patient dissatisfaction with the outcome. In this study, treatment with RECELL provided equivalent or superior results to current treatments in facial burn care in terms of wound healing, and excellent cosmetic outcomes.
“These preliminary results demonstrate excellent cosmetic outcomes when RECELL was used on deep partial-thickness facial burns,” said Joseph A. Molnar, MD, PhD, Wake Forest University School of Medicine, North Carolina, senior author of the presentation. “Patient satisfaction with the cosmetic outcome is critically important for these injuries, and I look forward to further evaluating how and where RECELL can be best utilized to treat patients with facial burns.”
The presentation by Dr. Walker, “Initial Experience with Autologous Cell Suspension for Treatment of Partial Thickness Facial Burns,” provided a retrospective review of clinical outcomes obtained in the treatment with the RECELL Device of patients with acute deep partial-thickness facial burn injuries under the Compassionate Use Investigational Device program. The Compassionate Use program was approved for patients with life-threatening wounds requiring grafting with no suitable alternative therapy that would be adequate to meet the patient’s medical need.
A total of 26 patients were treated at Wake Forest University School of Medicine, North Carolina, under the Compassionate Use program, five of whom had deep partial-thickness facial burns and were evaluated in this study. Patients in the facial burn study ranged from 2 to 40 years of age and had burns covering 35 percent to 62 percent of their total body surface area (TBSA).
Researchers led by Dr. Walker performed a retrospective review of outcomes of the patients in the study, including subjective cosmetic parameters, complications and number of reoperations. Detailed photographic documentation at multiple stages of the treatment procedures, and at multiple points in time post-procedure, were presented.
Jongwon Genevieve Park, MD, PhD, Wake Forest Baptist Medical Center, North Carolina, also presented “Validation and Characterization of an Immediate, One-Stage Technique to Treat Full-Thickness Wounds in Swine,” at the ABA Meeting, detailing the results of a preclinical model demonstrating the potential benefits of RECELL in combination with dermal substitutes in the treatment of full-thickness (third-degree) burns. The results of the study demonstrated that the addition of RECELL to either of two dermal substitutes accelerates epithelialization. Full-thickness burns are sometimes treated in a two-step process in which a dermal substitute is placed first, followed approximately two weeks later by a skin graft. This technique improves scarring but has the disadvantages of the need for multiple operations and the potential for donor site morbidity.
The goal of the preclinical study was to validate in a swine model a technique using RECELL and a dermal substitute to replace dermis and epidermis in a single surgery, and to minimize donor site morbidity. In the study, full-thickness wounds were treated with one of two dermal substitutes, RECELL alone, or RECELL in combination with each of the dermal substitutes. The study suggests that a dermal matrix combined with RECELL could be used as a one-stage procedure in the management of full-thickness burns.
“We are pleased to see researchers evaluate additional ways in which RECELL may potentially be used to treat patients with severe burn injuries,” said Dr. Michael Perry, AVITA Medical’s Chief Executive Officer. “These earlier-stage studies complement the broader body of scientific evidence supporting the benefits of RECELL, including our pivotal clinical trials presented this week, and we look forward to the continued exploration of the benefits of RECELL in high-unmet-need burns.”
The Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the US Department of Health and Human Services has provided funding under Contract No. HHSO100201500028C to support the development of RECELL by AVITA Medical, including the Compassionate Use program included in the presentation today.