Cellular treatment of chronic venous ulcers
This is quite a fascinating study and is a phase 2 randomised double blind study of cellular treatment of venous ulcers. Patients with non healing venous ulcers of the lower leg were treated with either the vehicle (fibrinogen and thrombin) – control group or with 4 different protocols of the vehicle with fibroblast and keratinocyte cells obtains obtained from the foreskin of an allogeneic donor. Two different cell doses were applied to the ulcers at either every 7 days or every 14 days. It should be noted that all patients had four-layer compression bandages applied and these were changed every week. At the end of 12 weeks there was a significant reduction in the size of the ulcers in all treatment groups, but in every case more so in the patients who received vehicle and cells. Again in the completely healed group more of these occurred in the cell treatment group than in the vehicle treatment group. There was also a reduction in pain in all of the treatment groups. Although the improvements are modest, in view of the careful conduct of this study the results are very important.