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A pilot study using cell-mixed sheets of autologous fibroblast cells and peripheral blood mononuclear cells to treat refractory cutaneous ulcers

Authors
  • Mizoguchi, Takahiro1
  • Suehiro, Kotaro1
  • Ueno, Koji1
  • Ike, Soichi1
  • Nagase, Takashi1
  • Samura, Makoto1
  • Harada, Takasuke1
  • Kurazumi, Hiroshi1
  • Suzuki, Ryo1
  • Harada, Koji2
  • Takami, Taro3, 4
  • Morikage, Noriyasu1
  • Hamano, Kimikazu1
  • 1 Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine, Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan
  • 2 Department of Oral and Maxillofacial Surgery, Yamaguchi University Graduate School of Medicine, Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan
  • 3 Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
  • 4 Center for Regenerative and Cell Therapy, Yamaguchi University Hospital, Ube, Yamaguchi, 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
Type
Published Article
Journal
American journal of translational research
Publisher
Madison, WI : e-Century Pub. Corp.
Publication Date
Aug 15, 2021
Volume
13
Issue
8
Pages
9495–9504
Identifiers
PMID: 34540071
PMCID: PMC8430109
Source
PubMed Central
Keywords
Disciplines
  • Original Article
License
Unknown

Abstract

Background/Aims: We invented a cell-mixed sheet consisting of autologous fibroblast cells and peripheral blood mononuclear cells (PBMNCs) to treat refractory cutaneous ulcers. These sheets secrete the growth factors needed throughout the wound healing process in animal models. Methods: We performed this study as a pilot phase I clinical trial (UMIN-CTR: UMIN000031645). Fibroblast cells were isolated and cultured from the oral tissue, and PBMNCs were collected by apheresis. A cell-mixed sheet was prepared by co-culturing these collected cells for 3 days. The primary observation index was safety, including all adverse events. Additional observation indices were wound healing over 1, 3, and 6 months; wound healing rate at 7 days and 1, 3, and 6 months. Results: Six patients with venous leg ulcers (VLUs) were enrolled in the study, including three patients who were treated with the cell-mixed sheet transplantation. One patient was excluded because no fibroblast cells grew from the oral tissue culture, and other two were excluded because the growth factor secreted from mixed-cell sheets did not reach the reference value. The VLUs of two patients who received the cell-mixed sheet transplantation healed, and the VLU in one patient decreased in size. Conclusions: This pilot study demonstrated that cell-mixed sheets might be a new topical intervention to treat VLUs. However, it was also suggested that this treatment might be limited when using autologous cells collected from patients with VLUs. Therefore, it may be necessary to use high-quality allogeneic cells instead of autologous cells to improve the feasibility of this treatment.

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