I. Mermet1, Nathalie Pottier2, Jean‐Marie Sainthillier3, Caroline Malugani2, Sandrive Cairey‐Remonnay1, Stéphane Maddens2,4, Didier Riethmuller5,6, Pierre Tiberghien2,4, Philippe Humbert3,1, F. Aubin5,1
1Université de Franche Comté, Department of Dermatology, University Hospital and Medical School,
2Cell and Tissue Engineering Department, Etablissement Français du Sang de Bourgogne-Franche-Comté,
3EA 3183, Université de Franche Comté, IFR 133,
4Inserm U645, Université de Franche-Comté, Etablissement Français du Sang, IFR133,
5EA 3181, Université de Franche-Comté, IFR 133, Besançon, France
6Université de Franche Comté, Department of Obstetrics and Gynecology, University Hospital and Medical School, and
Tóm tắt
ABSTRACTAmniotic membrane (AM), the most internal placental membrane, has unique properties including antiadhesive effects, bacteriostatic, wound protection and pain‐reduction properties, as well as epithelialization initialization capacities. Furthermore, AM is widely available and less costly than other bioengineered skin substitutes. In a prospective pilot study, we evaluated the safety, feasibility, and the effects on healing of AM graft in 15 patients with chronic venous leg ulcers. AM grafts were prepared from placentas harvested during cesarean section. All grafted AM had adhered to the wound bed 7 days after being applied with a 100% engraftment rate. The percentage of granulation tissue increased significantly (from 17% on day 0 to 69% on day 14, p<0.0001), along with a significant decrease of fibrinous slough (from 36% at day 0 to 16% at day 14, p<0.001). A significant clinical response occurred in 12 patients (80%) including complete healing (20%) in three during the 3‐month follow‐up period. The ulcer surface area decreased significantly from a mean value (±standard deviation) of 4.59±2.49 cm2 at baseline to 2.91±2.01 cm2 on day 30 (p<0.001). All patients experienced a significant reduction of ulcer‐related pain rapidly after AM transplantation. No adverse events were recorded. AM transplantation seems to function as a safe substrate, promoting proper epithelialization while suppressing excessive fibrosis. Further advantages of biotherapy with AM are its easy and low‐cost production, and that it can be applied as an ambulatory treatment without immobilization. AM transplantation may thus be considered to be an alternative method for treating chronic leg ulcers.
