By Helen Albert, Senior MedWire Reporter
A spray consisting of a mixture of keratinocyte and fibroblast skin cells holds promise for treatment of venous leg ulcers, show results from a phase II randomized controlled trial published in The Lancet.
"The treatment we tested in this study has the potential to vastly improve recovery times and overall recovery from leg ulcers, without the need for a skin graft," explained study author Herbert Slade (University of North Texas, Fort Worth, USA) in a press statement.
"This means not only that the patient doesn't acquire a new wound where the graft is taken from, but also that the spray-on solution can be available as soon as required - skin grafts take a certain amount of time to prepare, which exposes the patient to further discomfort and risk of infection."
Slade and team enrolled patients from 28 centers in the USA and Canada with a maximum of three leg ulcers. At least one ulcer had to measure 2-12 cm2 in area and have persisted for 6-104 weeks.
In total, 228 patients were randomly assigned to receive either placebo spray every 7 days (n=50), keratinocyte and fibroblast spray treatment containing 0.5 x 106 cells every 7 (n=43) or 14 days (n=46), or keratinocyte and fibroblast spray containing 5.0 x 106 cells every 7 (n=45) or 14 days (n=44).
The patients were followed-up for mean percentage change in wound area at 12 weeks. The team found that there was a significantly greater reduction in wound area in those given active treatment over placebo.
The most effective dose was 0.5 x 106 cells every 14 days, which produced a 15.9% greater reduction in wound area than placebo.
Adverse events did not differ significantly between the five treatment groups, with only new skin ulcers and cellulitis being reported in more than 5.0% of patients.
Writing in an accompanying commentary, Matthias Augustin and Wolfgang Vanscheidt (University Medical Center, Hamburg, Germany) say: "Even though compression is, and will remain, the basis of venous leg ulcer treatment, hard-to-heal ulcers do need additional therapy. In these wounds, prolonged futile, conservative treatment will increase costs without additional benefit.
"Therefore, the temporary higher costs for additional cell therapy can be justified as an investment in improved healing."
They applaud the researchers and encourage further research in this area adding that "the benefits observed in this study could well be observed also in other chronic wounds like ischemic and diabetic foot ulcers."
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