S Choi1, S-B Ryoo2, K J Park3, D-S Kim4, K-H Song4, K H Kim5, S S Chung5, E J Shin6, Y B Cho7, S T Oh8, W-K Kang8, M H Kim9. 1. Kangwon National University Hospital, 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, 24289, Republic of Korea. 2. Department of Surgery, Seoul National University Hospital, 101, Daehak-ro (28 Yeongeon-dong), Jongro-gu, Seoul, 03082, Republic of Korea. 3. Department of Surgery, Seoul National University Hospital, 101, Daehak-ro (28 Yeongeon-dong), Jongro-gu, Seoul, 03082, Republic of Korea. kjparkmd@plaza.snu.ac.kr. 4. Daehang Hospital, 2151, Nambusunhwan-ro, Seocho-gu, Seoul, 06699, Republic of Korea. 5. Ewha Womans University Medical Center, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, Republic of Korea. 6. Soonchunhyang University Hospital, 170, Jomaru-ro, Bucheon-si, Gyeonggi-do, 14584, Republic of Korea. 7. Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. 8. College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea. 9. Anterogen Co., Ltd., 130, Digital-ro, Geumcheon-gu, Seoul, 08589, Republic of Korea.
Abstract
PURPOSE: Injection of adipose tissue-derived stem cells (ASCs) is a novel method for the treatment of complex perianal fistulas. We aimed to evaluate the safety and efficacy of ASCs in the treatment of complex anal fistulas not associated with Crohn's disease. METHODS: A phase II clinical trial was performed comparing two different doses of ASCs (group 1: 1 × 107 cells/mL and group 2: 2 × 107 cells/mL). Eligible patients were administered an amount of ASCs proportional to the length of the fistula by injection into the submucosal layer surrounding the internal opening and inside of the fistula tract. ASCs at twice the initial concentration were administered if complete closure was not achieved within 8 weeks. The efficacy endpoint was the complete closure of fistulas 8 weeks after injection. Patients demonstrating complete closure at week 8 were subjected to follow-up for 6 months. RESULTS:Fifteen patients were injected with ASCs; thirteen completed the study. Complete closure was observed in 69.2% (9/13) of patients at 8 weeks. Three of five patients in group 1, and six of eight in group 2 displayed complete closure; no significant differences were observed between the groups. Six of nine patients who showed complete closure participated in additional follow-up; five (83.3%) showed persistent response at 6 months. No grade 3 or 4 adverse events (AEs) were observed; observed AEs were not related to ASC treatment. CONCLUSION:ASCs might be a good option for the treatment of complex perianal fistulas are not healed by conventional operative procedures.
RCT Entities:
PURPOSE: Injection of adipose tissue-derived stem cells (ASCs) is a novel method for the treatment of complex perianal fistulas. We aimed to evaluate the safety and efficacy of ASCs in the treatment of complex anal fistulas not associated with Crohn's disease. METHODS: A phase II clinical trial was performed comparing two different doses of ASCs (group 1: 1 × 107 cells/mL and group 2: 2 × 107 cells/mL). Eligible patients were administered an amount of ASCs proportional to the length of the fistula by injection into the submucosal layer surrounding the internal opening and inside of the fistula tract. ASCs at twice the initial concentration were administered if complete closure was not achieved within 8 weeks. The efficacy endpoint was the complete closure of fistulas 8 weeks after injection. Patients demonstrating complete closure at week 8 were subjected to follow-up for 6 months. RESULTS: Fifteen patients were injected with ASCs; thirteen completed the study. Complete closure was observed in 69.2% (9/13) of patients at 8 weeks. Three of five patients in group 1, and six of eight in group 2 displayed complete closure; no significant differences were observed between the groups. Six of nine patients who showed complete closure participated in additional follow-up; five (83.3%) showed persistent response at 6 months. No grade 3 or 4 adverse events (AEs) were observed; observed AEs were not related to ASC treatment. CONCLUSION: ASCs might be a good option for the treatment of complex perianal fistulas are not healed by conventional operative procedures.
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