Wednesday, October 29, 2003
3142

P33: Clinical Application of Fresh Fibroblast Allograft for the Treatment of Diabetic Foot Ulcers

Seung-Kyu Han, MD, PhD, Doo-Yang Lee, MD, Byung-Il Lee, MD, PhD, and Woo-Kyung Kim, MD, PhD.

Diabetic foot ulcers present a difficult treatment problem, because of a defect in fibroblast function. Although there has been much interest recently in the use of topical growth factors for the treatment of diabetic foot ulcer, the effect was generally not very dramatic. Several studies have reported that 4 to 17 weeks were needed to treat small size (1.2-4.3 square centimeters) of ulcers. As another way to deliver growth factors to wounds, cryopreserved fibroblast implant, which is able to adjust to the wound environment and provides growth factors and other substances that may be lacking in chronic wound, represent another exciting development and a major advance in the treatment of chronic wound. This product may well provide growth factors in the right concentration and in the right sequence, something that has proved difficult to achieve with the topical application of recombinant growth factors. However, cell activities are impaired by cryopreservation. Cells in the cryopreserved culture show about 50% viability. Protein synthesis is inhibited 70-98% by cryopreservation. In growth factor expression and angiogenesis, low recovery is shown. The purpose of this study was to assess the effects of fresh human allogeneic fibroblast graft for the treatment of diabetic foot ulcers. We treated 8 patients with diabetic foot ulcers. The duration of ulcers ranged from 6 to17 weeks. Wound size ranged from 2.5 to 6 square centimeters. Three patients had ulcers with exposed bone. Past history of diabetic foot ulcer was present in 5 patients. Human dermal fibroblasts from healthy teenagers were cultured. The culture medium used was DMEM/F-12 supplemented with 10% autologous serum. The cultured cells applied over the wound immediately following debridement. Fibrin was used as a cell carrier. A dressing was then applied with Tegaderm. The dressing remained moist until healing was achieved. The incidence and time for complete wound closure and patient satisfaction were assessed. Follow-up time ranged from 6 to 11 months. The incidence of complete wound healing was 100%. Eleven to twenty-one days were needed for complete reepithelization of the wound. There were no clinical or laboratory abnormalities noted, and there were no adverse events. Patient satisfaction was also very positive. The use of fresh human fibroblast allograft is a safe and effective treatment for diabetic foot ulcers.


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