Randomised trial of skin cell suspension confirms efficacy for healing of venous ulcers

Paul Hayes
Paul Hayes

Use of autologous skin cell suspension (ASCS) in addition to compression has been shown to accelerate healing in large venous leg ulcers (VLUs), according to the results of a multicentre randomised trial conducted in the UK. Writing in the International Wound Journal (IWJ), investigators confirm that the method represents a “a safe and effective approach for treatment of VLUs” and is capable of improving health-related quality of life.

As Paul Hayes (St John’s Innovation Centre, Cambridge, UK) and colleagues explain, ASCS can be prepared in a clinical setting using the RECELL Autologous Cell Harvesting Device (AVITA Medical), allowing the dispersion of single cells across the surface of the wound bed. “In addition to the placement of skin cells where they are needed, the disaggregation process may induce changes normally associated with loss of contact inhibition, thereby activating cellular processes associated with wound healing.”

According to the authors, applications of ASCS are employed frequently in burn care, promoting epidermal regeneration in deep partial-thickness and full-thickness injuries. “More recently,” Hayes et al continue, “ASCS has been used to benefit patients who have ulcers of various aetiologies, including VLUs and diabetic foot ulcers.”

It has been observed by investigators of previous studies that the application of ASCS can restart healing of wounds such as VLUs, by modulating the wound environment and providing healthy cells. Although previous investigations into the use of ASCS for the treatment of chronic wounds have demonstrated the potential of the technique, it has not been evaluated in comparison to standard compression therapy in a randomised trial.

The aim of this study, a multicentre, prospective, randomised controlled clinical trial, was to “evaluate the preliminary effectiveness and safety associated with the use of ASCS for the treatment of chronic leg ulcers associated with venous insufficiency”. Hayes et al write that subjects with open leg ulceration were recruited from six sites in England and one site in France between July 2013 and November 2015, with an inclusion criteria of ulcers present for at least four weeks and with an area of 2–80cm2.

Furthermore, all subjects underwent clinical assessment and ankle-brachial pressure index (ABPI) measurements to confirm eligibility (ABPI<0.8), with the trial also requiring patients to have confirmed, managed venous reflux and an ulcer defined as a C6, according to the CEAP (Clinical, Aetiology, Anatomy, and Pathophysiology) classification system.

Overall, 52 patients were enrolled in the study and subsequently randomised into one of two groups: the study group of autologous skin cell suspension (ASCS) combined with compression therapy, and a control group of standard compression alone. Patients in these groups were assessed in terms of the primary effectiveness endpoint—incidence of complete wound closure (45 out of 52 completed follow up to week 14)—as well as donor site closure, pain, health-related quality of life, satisfaction, and safety.

Focusing on the results, Hayes et al write: “At week 14, VLUs treated with ASCS plus compression had a statistically greater decrease in ulcer area compared with the control [patients] (8.94cm2 vs. 1.23cm2, p=0.0143). This finding was largely driven by ulcers less than 10–80cm2 in size, as these ulcers had a higher mean percentage of re-epithelialisation at 14 weeks (ASCS plus compression: 69.97%, control: 11.07%, p=0.0480).”

The authors continue, also revealing that subjects treated with ASCS plus compression experienced a statistically significant decrease in pain rating (p=0.017) and increase in all aspects of health-related quality of life, compared to patients in the control cohort. With respect to the latter, the authors detail that differences between the groups emerged by four weeks and “reached statistical significance by eight weeks for cosmesis (p=0.0145) and 14 weeks for emotional well-being (p=0.0439)”.

Although there was no significant difference between the two cohorts in terms of patient satisfaction, it was noted the ACSC plus compression group had slightly higher satisfaction scores in both the subject and physician ratings for all wounds, while a similar percentage of patients in each group experienced adverse events (17 in ASCS plus compression group versus 16 in compression group). Infection rates were also similar, though “by week 14, four subjects in the compression only group had mild or moderate infection versus no observable infection in the treatment group”.

Hayes et al conclude, emphasising that “results from this study indicate that application of ASCS…appears to be a safe and an effective approach for treatment of VLUs when combined with compression therapy, specifically for ulcers greater than 10–80cm2 in area”.

“In addition to the healing potential, the reduction in pain and improvement in health-related quality of life may have implications on the overall reduction of costs associated with the treatment of VLUs regardless of ulcer size. Future work is warranted to study the effect of ASCS plus compression on wounds, evaluating the healing outcomes and impact that a decrease in wound size has on pain and the cost-effectiveness of the treatment.”


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