Scientists have successfully treated chronic diabetic foot ulcers using skin grafts grown from individual patient cell samples.
Of the five men treated using autologous fibroblast-seeded artificial dermis (AFD) for an ulcer lasting an average of 22.6 months, three patients had complete wound closure within 12 weeks of grafting, and two patients had over 80% and 90% healing respectively.
The primary endpoint of "wound bed improvement" - defined as a 60% or greater increase in granulation area by day 21 - was achieved by all five patients, demonstrating that the healing process had begun in each ulcer.
In addition, there was an overall significant reduction in mean wound area, from 7.07 cm2 at AFD application to 3.42 cm2 at day 21.
The patients remained in hospital for 21 days to allow graft stabilization and no topical wound healing accelerants were applied. There were no serious side effects linked to the AFD, with one report of skin infection and one of wound pain "probably" associated with the AFD.
"Although this study was a preliminary clinical trial with a small sample size, our dermal substitutes may provide a safe and effective treatment of diabetic ulcers," write Naoki Morimoto (Kyoto University, Japan) and co-authors in the International Wound Journal.
The team explains that their AFS process does not use any animal-derived materials, such as fetal bovine serum or typsin, and thus avoids the potential risks for viral or prion infection or immune or inflammatory reactions to bovine proteins. The cells were cultured from skin biopsies using animal product-free medium supplemented with 2% patient autologous serum.
Morimoto et al note that systemic complications in diabetes patients, such as chronic renal failure, can make it difficult to harvest large amounts of autologous serum.
"In this study, the average amount of autologous serum needed for the preparation of AFD was 11·6 mL and this amount would not be an issue in diabetic patients, even those on haemodialysis," they emphasize.
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