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.
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.
Authors: Jaco H Houtgraaf; Wijnand K den Dekker; Bas M van Dalen; Tirza Springeling; Renate de Jong; Robert J van Geuns; Marcel L Geleijnse; Francisco Fernandez-Aviles; Felix Zijlsta; Patrick W Serruys; Henricus J Duckers Journal: J Am Coll Cardiol Date: 2012-01-31 Impact factor: 24.094
Authors: Stig-Frederik Trojahn Kølle; Anne Fischer-Nielsen; Anders Bruun Mathiasen; Jens Jørgen Elberg; Roberto S Oliveri; Peter V Glovinski; Jens Kastrup; Maria Kirchhoff; Bo Sonnich Rasmussen; Maj-Lis Møller Talman; Carsten Thomsen; Ebbe Dickmeiss; Krzysztof Tadeusz Drzewiecki Journal: Lancet Date: 2013-09-28 Impact factor: 79.321
Authors: Gerardo Marino; Marco Moraci; Emilia Armenia; Consiglia Orabona; Renato Sergio; Gabriele De Sena; Vincenza Capuozzo; Manlio Barbarisi; Francesco Rosso; Giovanni Giordano; Francesco Iovino; Alfonso Barbarisi Journal: J Surg Res Date: 2013-05-28 Impact factor: 2.192
Authors: Jalees Rehman; Dmitry Traktuev; Jingling Li; Stephanie Merfeld-Clauss; Constance J Temm-Grove; Jason E Bovenkerk; Carrie L Pell; Brian H Johnstone; Robert V Considine; Keith L March Journal: Circulation Date: 2004-03-01 Impact factor: 29.690
Authors: Lauren H Mangum; Shanmugasundaram Natesan; Randolph Stone; Nicole L Wrice; David A Larson; Kyle F Florell; Barbara A Christy; Maryanne C Herzig; Andrew P Cap; Robert J Christy Journal: Stem Cells Int Date: 2017-08-23 Impact factor: 5.443