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

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

来源：Surgery Today, 2016, 46(7): 835-842.

DOI：10.1007/s00595-015-1246-8

• Adipose-derived regenerative cells
• Adipose-derived stem cells
• Cell therapy
• Enterocutaneous fistula

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.

• 出版日期2016-7