A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula

Tsunekazu Mizushima, Hidekazu Takahashi, Hiroshi Takeyama, Atsushi Naito, Naotsugu Haraguchi, Mamoru Uemura, Junichi Nishimura, Taishi Hata, Ichiro Takemasa, Hirofumi Yamamoto, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Purpose: Adipose-derived stem cell (ADSC) transplantation is expected to be a minimally invasive, but effective, treatment for postoperative enterocutaneous fistulas associated with poor blood flow and chronic inflammation. The aim of this study was to assess the safety and efficacy of a novel ADSC therapy for this condition. Methods: We conducted an open-label, single-arm exploratory phase I study to assess the safety and efficacy of a novel ADSC therapy. Using the Celution system, we isolated adipose-derived regenerative cells (ADRCs) containing abundant ADSCs from liposuction-obtained gluteal adipose tissue. A mixture of ADRCs and fibrin glue was subsequently transplanted into the fistula, and ADRCs were percutaneously and endoscopically injected around the fistula. We evaluated the safety and feasibility of ADRC transplantation and fistula closure in six patients (UMIN000007316). Results: ADRC transplantation was completed in all patients. The fistula closure rates were 83.3 % at 4 and 12 weeks and 100 % at 24 weeks. All patients had grade 1 pain and subcutaneous hemorrhage at the liposuction sites, but no serious adverse events related to this procedure were observed. Conclusions: Transplantation of autologous ADRCs is safe, feasible and advantageous, as it can secure a sufficient cell count without culture or multiple passages, and will likely be effective for a postoperative enterocutaneous fistula.

Original languageEnglish
Pages (from-to)835-842
Number of pages8
JournalSurgery today
Volume46
Issue number7
DOIs
Publication statusPublished - Jul 1 2016

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Intestinal Fistula
Cell Transplantation
Fistula
Clinical Trials
Lipectomy
Cell- and Tissue-Based Therapy
Safety
Stem Cells
Fibrin Tissue Adhesive
Autologous Transplantation
Stem Cell Transplantation
Adipose Tissue
Cell Count
Hemorrhage
Inflammation
Pain

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula. / Mizushima, Tsunekazu; Takahashi, Hidekazu; Takeyama, Hiroshi; Naito, Atsushi; Haraguchi, Naotsugu; Uemura, Mamoru; Nishimura, Junichi; Hata, Taishi; Takemasa, Ichiro; Yamamoto, Hirofumi; Doki, Yuichiro; Mori, Masaki.

In: Surgery today, Vol. 46, No. 7, 01.07.2016, p. 835-842.

Research output: Contribution to journalArticle

Mizushima, T, Takahashi, H, Takeyama, H, Naito, A, Haraguchi, N, Uemura, M, Nishimura, J, Hata, T, Takemasa, I, Yamamoto, H, Doki, Y & Mori, M 2016, 'A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula', Surgery today, vol. 46, no. 7, pp. 835-842. https://doi.org/10.1007/s00595-015-1246-8
Mizushima, Tsunekazu ; Takahashi, Hidekazu ; Takeyama, Hiroshi ; Naito, Atsushi ; Haraguchi, Naotsugu ; Uemura, Mamoru ; Nishimura, Junichi ; Hata, Taishi ; Takemasa, Ichiro ; Yamamoto, Hirofumi ; Doki, Yuichiro ; Mori, Masaki. / A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula. In: Surgery today. 2016 ; Vol. 46, No. 7. pp. 835-842.
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AU - Takeyama, Hiroshi

AU - Naito, Atsushi

AU - Haraguchi, Naotsugu

AU - Uemura, Mamoru

AU - Nishimura, Junichi

AU - Hata, Taishi

AU - Takemasa, Ichiro

AU - Yamamoto, Hirofumi

AU - Doki, Yuichiro

AU - Mori, Masaki

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AB - Purpose: Adipose-derived stem cell (ADSC) transplantation is expected to be a minimally invasive, but effective, treatment for postoperative enterocutaneous fistulas associated with poor blood flow and chronic inflammation. The aim of this study was to assess the safety and efficacy of a novel ADSC therapy for this condition. Methods: We conducted an open-label, single-arm exploratory phase I study to assess the safety and efficacy of a novel ADSC therapy. Using the Celution system, we isolated adipose-derived regenerative cells (ADRCs) containing abundant ADSCs from liposuction-obtained gluteal adipose tissue. A mixture of ADRCs and fibrin glue was subsequently transplanted into the fistula, and ADRCs were percutaneously and endoscopically injected around the fistula. We evaluated the safety and feasibility of ADRC transplantation and fistula closure in six patients (UMIN000007316). Results: ADRC transplantation was completed in all patients. The fistula closure rates were 83.3 % at 4 and 12 weeks and 100 % at 24 weeks. All patients had grade 1 pain and subcutaneous hemorrhage at the liposuction sites, but no serious adverse events related to this procedure were observed. Conclusions: Transplantation of autologous ADRCs is safe, feasible and advantageous, as it can secure a sufficient cell count without culture or multiple passages, and will likely be effective for a postoperative enterocutaneous fistula.

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