A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula
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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.
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).
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.
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.
KeywordsAdipose-derived regenerative cells Adipose-derived stem cells Cell therapy Enterocutaneous fistula
We thank Dr. Ezoe and the members of the Medical Center for Translational Research, Osaka University Hospital for helpful suggestions and discussions. We also thank Ms. Maruyama and Ms. Shimamoto for help with the data collection. This work was supported by a Grant-in-Aid for Scientific Research (C), the Takeda Science Foundation, and the Japanese Society for Advancement of Surgical Techniques.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflicts of interest.
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