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05.09.2015 | Original Article

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

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

Erschienen in: Surgery Today | Ausgabe 7/2016

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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.

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Titel: A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula
verfasst von: Tsunekazu Mizushima
Hidekazu Takahashi
Hiroshi Takeyama
Atsushi Naito
Naotsugu Haraguchi
Mamoru Uemura
Junichi Nishimura
Taishi Hata
Ichiro Takemasa
Hirofumi Yamamoto
Yuichiro Doki
Masaki Mori
Publikationsdatum: 05.09.2015
Verlag: Springer Japan
Erschienen in: Surgery Today / Ausgabe 7/2016
Print ISSN: 0941-1291
Elektronische ISSN: 1436-2813
DOI: https://doi.org/10.1007/s00595-015-1246-8

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