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Back to 2014 Annual Meeting Abstracts Allogeneic Adipose-Derived Stem Cells for the Treatment of Crohn's Perianal Fistula: a Phase I/Iia Clinical Study Kyu Joo Park*1, Joo Sung Kim2, Won Ho Kim3, Hyo Jong Kim5, Kil Yeon Lee6, Seung Hyuk Baik4, Tae IL Kim3 1Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea; 2Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; 3Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; 4Surgery, Yonsei University College of Medi, Seoul, Republic of Korea; 5Internal Medicine, Kyung Hee University College of Medicine, Seoul, Republic of Korea; 6Surgery, Kyung Hee University College of Medicine, Seoul, Republic of Korea Background: The treatment of Crohn's perianal fistula remains an extremely challenging problem as many fistulae do not respond to conventional surgical and/or medical management and recurrence rates are substantial. We have previously demonstrated that autologous adipose tissue-derived stem cells (ASCs) are safe and have therapeutic potential for healing perianal fistula associated with Crohn's disease. Aim: This clinical study was aimed to evaluate the safety and efficacy of allogenic adipose-derived stem cells (ALLO-ASCs) for the treatment of perianal fistula in Crohn's disease. Methods: The study was designed multicenter, randomized phase I/IIa clinical study to compare two different doses of ALLO-ASCs. In this dose escalation study, patients were sequentially enrolled in two dosing group with three patients in each group. The first three patients (group 1) were given 1 x 107cell/ml based on the size of fistula tract. After 4 weeks, this dose was deemed safe, and additional three patients (group 2) were given 3 x 107cell/ml. Efficacy endpoint was complete closure at 8 weeks after injection, defined as a complete closure of external opening without any sign of drainage and inflammation. Patients who completed visit at 8 weeks were followed up for an additional 6 months. Results: There were no grade 3 or 4 severity adverse events and no events were related to ALLO-ASC. Two patients in group 1 showed over 50% closure of fistula at 8 weeks after injection. Of the three patients enrolled in group 2, one showed complete closure at 8 weeks. Five out of six patients were then monitored for additional 6 months. Two out of 3 patients in group 1, and one of 2 patients in group 2 maintained complete closures of the fistula at 8 months. Invstigator's satisfaction showed similar results with efficacy of ALLO-ASC. Conclusions: Our data suggests that Allogenic adipose-derived stem cells (ALLO-ASCs) are tolerable, safety, and demonstrated efficacy and feasibility for treatment of Crohn's fistula. Back to 2014 Annual Meeting Abstracts |
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