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

S. Tawqeer Rashid, Naveen Cavale, Frank L. Bowling

Research output: Contribution to journalArticlepeer-review

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 cm 2 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 reepithelialization of 84.9% and 12.2 cm 2 reduction in ulcer area. For ulcers that did not acquire a soft tissue infection post-treatment, all either healed or achieved ≥95% reepithelialization 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 postoperative 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.

Original languageEnglish
Pages (from-to)719-727
Number of pages9
JournalWound Repair and Regeneration
Volume28
Issue number6
Early online date19 Jul 2020
DOIs
Publication statusPublished - Nov 2020

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Cell Transplantation/methods
  • Cell- and Tissue-Based Therapy/methods
  • Diabetic Foot/therapy
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Skin/cytology
  • Suspensions
  • Transplantation, Autologous
  • Treatment Outcome
  • Wound Healing/physiology

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