PMID- 28567691
OWN - NLM
STAT- MEDLINE
DCOM- 20180710
LR  - 20181113
IS  - 1128-045X (Electronic)
IS  - 1123-6337 (Linking)
VI  - 21
IP  - 5
DP  - 2017 May
TI  - 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.
PG  - 345-353
LID - 10.1007/s10151-017-1630-z [doi]
AB  - 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 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. 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.
FAU - Choi, S
AU  - Choi S
AD  - Kangwon National University Hospital, 156, Baengnyeong-ro, Chuncheon-si, 
      Gangwon-do, 24289, Republic of Korea.
FAU - Ryoo, S-B
AU  - Ryoo SB
AD  - Department of Surgery, Seoul National University Hospital, 101, Daehak-ro (28 
      Yeongeon-dong), Jongro-gu, Seoul, 03082, Republic of Korea.
FAU - Park, K J
AU  - Park KJ
AD  - 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.
FAU - Kim, D-S
AU  - Kim DS
AD  - Daehang Hospital, 2151, Nambusunhwan-ro, Seocho-gu, Seoul, 06699, Republic of 
      Korea.
FAU - Song, K-H
AU  - Song KH
AD  - Daehang Hospital, 2151, Nambusunhwan-ro, Seocho-gu, Seoul, 06699, Republic of 
      Korea.
FAU - Kim, K H
AU  - Kim KH
AD  - Ewha Womans University Medical Center, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 
      07985, Republic of Korea.
FAU - Chung, S S
AU  - Chung SS
AD  - Ewha Womans University Medical Center, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 
      07985, Republic of Korea.
FAU - Shin, E J
AU  - Shin EJ
AD  - Soonchunhyang University Hospital, 170, Jomaru-ro, Bucheon-si, Gyeonggi-do, 
      14584, Republic of Korea.
FAU - Cho, Y B
AU  - Cho YB
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, 
      Gangnam-gu, Seoul, 06351, Republic of Korea.
FAU - Oh, S T
AU  - Oh ST
AD  - College of Medicine, The Catholic University of Korea, 222, Banpo-daero, 
      Seocho-gu, Seoul, 06591, Republic of Korea.
FAU - Kang, W-K
AU  - Kang WK
AD  - College of Medicine, The Catholic University of Korea, 222, Banpo-daero, 
      Seocho-gu, Seoul, 06591, Republic of Korea.
FAU - Kim, M H
AU  - Kim MH
AD  - Anterogen Co., Ltd., 130, Digital-ro, Geumcheon-gu, Seoul, 08589, Republic of 
      Korea.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170531
PL  - Italy
TA  - Tech Coloproctol
JT  - Techniques in coloproctology
JID - 9613614
SB  - IM
MH  - Adipocytes/*transplantation
MH  - Adipose Tissue/*cytology
MH  - Adult
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Rectal Fistula/etiology/*therapy
MH  - Stem Cell Transplantation/*methods
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adipose tissue-derived
OT  - Autologous
OT  - Complex
OT  - Perianal fistula
OT  - Stem cells
EDAT- 2017/06/02 06:00
MHDA- 2018/07/11 06:00
CRDT- 2017/06/02 06:00
PHST- 2016/06/20 00:00 [received]
PHST- 2017/04/16 00:00 [accepted]
PHST- 2017/06/02 06:00 [pubmed]
PHST- 2018/07/11 06:00 [medline]
PHST- 2017/06/02 06:00 [entrez]
AID - 10.1007/s10151-017-1630-z [pii]
AID - 10.1007/s10151-017-1630-z [doi]
PST - ppublish
SO  - Tech Coloproctol. 2017 May;21(5):345-353. doi: 10.1007/s10151-017-1630-z. Epub 
      2017 May 31.