Journal
ANNALS OF SURGICAL TREATMENT AND RESEARCH
Volume 101, Issue 1, Pages 58-64Publisher
KOREAN SURGICAL SOCIETY
DOI: 10.4174/astr.2021.101.1.58
Keywords
Autologous stem cells; Mesenchymal stem cells; Pediatric Crohn's disease
Categories
Funding
- Anterogen Corp.
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This Phase IV study evaluated the efficacy and safety of autologous adipose tissue-derived stem cells (ASCs) in children with refractory Crohn's fistulae, showing that four out of five patients experienced fistula healing after ASC injection, with one achieving complete and sustained closure after six months. ASC therapy was well-tolerated and considered a simple therapeutic option, but further data from more patients is needed.
Purpose: Autologous adipose tissue-derived stem cells (ASCs) have been proposed for patients with refractory Crohn disease, but research is lacking in pediatric patients. This Phase IV study evaluated the efficacy and safety of ASCs in children with refractory Crohn's fistulae. Methods: Patients with a refractory Crohn's fistula who did not have conventional therapy for more than 3 months or with a recurrent complex Crohn's fistula were included. All patients were at least 14 years old. Patients with infection, poor condition, or active Crohn disease with a disease activity index of 450 and above were excluded. Five patients were treated with ASCs from 2014 to 2015 in Asan Medical Center. ASC administration was adjusted according to fistula size (1 mL per cm(2)). We evaluated the efficacy and safety 8 weeks after injection and followed patients for 6 months. Results: Fistulae were healed in 4 patients by 8 weeks after ASC injection. Of these 4 patients, 1 had complete fistula closure and sustainability after 6 months. The other 3 with healing effects had less than 50% fistula closure by 6 months. None of these 4 patients have persistent fistulae. One patient had no healing effect, and seton ligation was performed 8 months after ASC injection. There were no adverse effects related to ASC administration. Conclusion: ASC therapy is a simple and well-tolerated therapeutic option for children with refractory Crohn's complex fistulae. Complete closure was well-sustained. However, more data from a larger number of patients are needed.
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