Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Stem Cells. Mar 26, 2024; 16(3): 257-266
Published online Mar 26, 2024. doi: 10.4252/wjsc.v16.i3.257
Long-term outcome of stem cell transplantation with and without anti-tumor necrotic factor therapy in perianal fistula with Crohn’s disease
Min Young Park, Yong Sik Yoon, Jae Ha Park, Jong Lyul Lee, Chang Sik Yu
Min Young Park, Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul 03722, South Korea
Yong Sik Yoon, Jae Ha Park, Jong Lyul Lee, Chang Sik Yu, Division of Colon and Rectal Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, South Korea
Author contributions: Park MY designed and performed the research and wrote the paper; Yoon YS designed the research and supervised the report; Park JH contributed to the analysis; Lee JL and Yu CS provided clinical advice and supervised the report.
Supported by the grants from the Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea, No. 2019IF0593 and No. 2020IP0039.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Board of Asan Medical Center (No. 2020-1059).
Informed consent statement: This is a retrospective study that used anonymous data, and the Institutional Review Board of Asan Medical Center approved the study and waived informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yong Sik Yoon, MD, PhD, Professor, Division of Colon and Rectal Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, South Korea. yoonys@amc.seoul.kr
Received: October 13, 2023
Peer-review started: October 13, 2023
First decision: December 11, 2023
Revised: December 25, 2023
Accepted: February 18, 2024
Article in press: February 18, 2024
Published online: March 26, 2024
Processing time: 163 Days and 21.3 Hours
ARTICLE HIGHLIGHTS
Research background

Perianal fistulas are a common complication in Crohn’s disease, with a higher incidence in East Asia. Stem cell transplantation, specifically using autologous adipose tissue-derived stem cells (ASCs), has been explored as a potential effective and safe therapeutic approach, with favorable results reported in South Korean studies.

Research motivation

While the combination of medication and surgery has shown promise, the effectiveness of combining biologics such as anti-tumor necrosis factor (TNF) agents with stem cell transplantation remains an unproven area in improving fistula closure outcomes.

Research objectives

The study focused on assessing the long-term outcomes of stem cell transplantation, comparing closure rates with and without anti-TNF therapy, and evaluating risk factors for therapeutic failure and recurrence in Crohn’s perianal fistula (CPF) after stem cell transplantation.

Research methods

This retrospective study, conducted at Asan Medical Center in Seoul, Korea, aimed to evaluate the long-term outcomes of stem cell transplantation in patients with CPF. Data from patients who underwent stem cell transplantation from June 2014 to December 2022 were reviewed, considering clinical variables such as age, sex, smoking status, and Montreal classification subclass. Autologous ASCs were used, and the study also included information on surgical procedures, anti-TNF agents (infliximab and adalimumab) used, and postoperative management. The study focused on comparing closure rates between patients who underwent stem cell transplantation with and without biologics, defining closure as the absence of discharge, swelling, or pain, and recurrence as the relapse of symptoms after the closure of the fistulous tract. Statistical analyses were performed to assess differences in outcomes.

Research results

Between June 2014 and December 2022, a total of 65 patients underwent stem cell transplantation for the treatment of CPF, with 26 receiving preoperative anti-TNF agents. The mean follow-up duration was 66.09 ± 32.37 months. Among all patients, 76.9% achieved complete closure of perianal fistula, and the recurrence rate after closure was 14.0%. The closure rates at 1 and 2 years for patients with anti-TNF treatment were 63.0% and 66.7%, respectively, while for those without anti-TNF treatment, the rates were 68.4%, 78.9%, and 81.6% at 1, 2, and 3 years, respectively. Fistula closure was less likely in patients with longer fistulas (> 7 cm), proctitis, and rectal stricture. The cumulative closure rate, excluding those with recurrence, was approximately 66.1%. The use of anti-TNF agents did not significantly impact closure and recurrence rates.

Research conclusions

In conclusion, stem cell transplantation emerges as a viable treatment option for CPF, with favorable outcomes expected in appropriate patients regardless of the use of anti-TNF agents. This study suggests that selecting patients based on clinical features such as proctitis or stricture, along with considering the length of the fistulous tract, plays an important role in influencing the prognosis of fistula closure.

Research perspectives

The study, conducted at a single center with a limited number of patients, underscores the need for further research involving a larger multi-center cohort to thoroughly investigate the long-term outcomes and prognostic factors associated with stem cell transplantation in patients with CPF.