A pilot feasibility study of non‐cultured autologous skin cell suspension for healing diabetic foot ulcers

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Abstract

A prospective, single arm feasibility study was conducted to evaluate healing outcomes of DFUs treated with autologous skin cell suspension (ASCS) in combination with standard therapy. Wounds up to 100 cm2 in size that failed to heal with conventional therapy were included and wound healing, pain, exudate scores, Quality of Life, satisfaction scores, and safety outcomes were evaluated over a period of 26 weeks. Sixteen subjects were enrolled having a mean DFU duration of 60.4 weeks. All ulcers in this study had a positive healing trajectory, with a mean re‐epithelialisation of 84.9% and 12.2 cm2 reduction in ulcer area. For ulcers that did not acquire a soft tissue infection post‐treatment, all either healed or achieved ≥95% re‐epithelialisation including some with exposed tendon. Improvements were observed in all aspects of the health‐related Quality of Life questionnaire and subjects and clinicians were highly satisfied across all post‐operative visits. This preliminary study suggests ASCS is a well‐tolerated and promising therapy for the treatment of DFUs as all ulcers evaluated experienced positive healing results regardless of size, depth, and wound duration. Future studies are warranted to investigate ASCS compared to standard of care for all diabetic foot ulcers, inclusive of the evaluation of treatment algorithms and combination products.

Bibliographical metadata

Original languageEnglish
JournalWound Repair and Regeneration
Early online date19 Jul 2020
DOIs
Publication statusE-pub ahead of print - 19 Jul 2020