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Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy

Title
Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy
Authors
Choi, S.Ryoo, S. -B.Park, K. J.Kim, D. -S.Song, K. -H.Kim, K. H.Chung, S. S.Shin, E. J.Cho, Y. B.Oh, S. T.Kang, W. -K.Kim, M. H.
Ewha Authors
김광호
SCOPUS Author ID
김광호scopus
Issue Date
2017
Journal Title
TECHNIQUES IN COLOPROCTOLOGY
ISSN
1123-6337JCR Link1128-045XJCR Link
Citation
vol. 21, no. 5, pp. 345 - 353
Keywords
Stem cellsAdipose tissue-derivedAutologousPerianal fistulaComplex
Publisher
SPRINGER-VERLAG ITALIA SRL
Indexed
SCIE; SCOPUS WOS
Abstract
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. A phase II clinical trial was performed comparing two different doses of ASCs (group 1: 1 x 10(7) cells/mL and group 2: 2 x 10(7) 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. 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. ASCs might be a good option for the treatment of complex perianal fistulas are not healed by conventional operative procedures.
DOI
10.1007/s10151-017-1630-z
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의학전문대학원 > 의학과 > Journal papers
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