A comparative study of cell therapy and fibrin glue applied to chronic venous ulcers

The hypothesis is that cell therapy with autologous keratinocytes promotes healing of chronic venous ulcers that failed to respond to other forms of treatment. This is a randomized study in which 31 patients with chronic venous ulcers participated, totaling 38 venous ulcers. Thirty one ulcers were included in Group 1 (G1) treated with autologous keratinocytes applied at the ulcers' base with autologous fibrin scaffold. Group 2 (G2) included 7 ulcers treated with autologous fibrin glue only. The ulcers were evaluated with digital photography and computer image analysis [area and wound healing rate (WHR)] over 90 days. The duration of ulcers from the G1 was 118 months on average and in G2 the average was 114 months without any difference. In relation to the initial size of ulcers, both groups were similar considering the mean, SD and median respectively: G1 (18; 27; 5.6 cm(2)) and G2 (19.5; 0.11; 0.29 cm(2)). The medians of WHR in G1 and G2 have got significant differences between groups. Considering only the wounds that reached WHR larger than 0.4 (40% rate of healing), in the G1, 29% of ulcers reached it at the 30th day, 58% at the 45th, 77% at the 60th, 84% at the 75th and 90% at the 90th day while in the G2 only 14% (one ulcer) reached it at the 30th day remaining steady until the 90th day when only one more ulcer reached this rate (28.6%). The median of procedures was 2 for G1 and 3 for G2. These findings showed the relevant efficacy of cell therapy with autologous keratinocytes applied with autologous fibrin glue scaffold achieving high rates of healing from the thirtieth day of follow-up and becoming larger by the ninetieth day. In contrast, the autologous fibrin glue applied lonely in G2 did not improve the wound healing significantly. The cell therapy with autologous keratinocytes applied with autologous fibrin scaffold promotes greater healing of chronic venous ulcers than autologous fibrin glue only, particularly large recalcitrant ulcers that do not respond to conventional treatment. (C) 2013 The Authors. Published by Elsevier Ltd.