Evaluating the safety and efficacy of mesenchymal stem cell-derived exosomes for treatment of refractory perianal fistula in IBD patients: clinical trial phase I.
Crohn’s disease
IBD
MSCs
exosome
fistula
Journal
Gastroenterology report
ISSN: 2052-0034
Titre abrégé: Gastroenterol Rep (Oxf)
Pays: England
ID NLM: 101620508
Informations de publication
Date de publication:
2022
2022
Historique:
received:
02
07
2022
revised:
05
11
2022
accepted:
20
11
2022
entrez:
15
12
2022
pubmed:
16
12
2022
medline:
16
12
2022
Statut:
epublish
Résumé
Exosome administration is a novel medical approach that promises excellent immunomodulatory properties without the conventional side effects of current antitumor necrosis factor drugs and stem cells. This study aimed to assess the safety and efficacy of using mesenchymal stem cell (MSC) exosomes to treat refractory fistulas in patients with inflammatory bowel disease. MSCs were derived from the umbilical cords and their exosomes were isolated. Five patients with refractory perianal Crohn's disease fistulas with a median age of 35 years (range 31-47 years) were enrolled in the study. Exosome injections were administered in the operating room to patients with refractory fistula (fistulas that are irresponsive to anti-tumor necrosis factor-α administration within 6 months). Six months later, a physical examination, face-to-face interviews, and magnetic resonance imaging were employed to evaluate the therapy responses of patients. The outcomes within 6 months after initiation of therapy showed that four patients had responded to therapy. Three patients who received exosome injections exhibited complete healing, while one reported no improvement and active discharge from the fistula site. In addition, five patients (100%) reported neither systemic nor local adverse effects. Injection of exosomes extracted from MSCs demonstrates safety and a satisfactory therapeutic effect, as evidenced in this and other studies, and may play a significant role in the future treatment of gastrointestinal fistulas.
Sections du résumé
Background
UNASSIGNED
Exosome administration is a novel medical approach that promises excellent immunomodulatory properties without the conventional side effects of current antitumor necrosis factor drugs and stem cells. This study aimed to assess the safety and efficacy of using mesenchymal stem cell (MSC) exosomes to treat refractory fistulas in patients with inflammatory bowel disease.
Methods
UNASSIGNED
MSCs were derived from the umbilical cords and their exosomes were isolated. Five patients with refractory perianal Crohn's disease fistulas with a median age of 35 years (range 31-47 years) were enrolled in the study. Exosome injections were administered in the operating room to patients with refractory fistula (fistulas that are irresponsive to anti-tumor necrosis factor-α administration within 6 months). Six months later, a physical examination, face-to-face interviews, and magnetic resonance imaging were employed to evaluate the therapy responses of patients.
Results
UNASSIGNED
The outcomes within 6 months after initiation of therapy showed that four patients had responded to therapy. Three patients who received exosome injections exhibited complete healing, while one reported no improvement and active discharge from the fistula site. In addition, five patients (100%) reported neither systemic nor local adverse effects.
Conclusions
UNASSIGNED
Injection of exosomes extracted from MSCs demonstrates safety and a satisfactory therapeutic effect, as evidenced in this and other studies, and may play a significant role in the future treatment of gastrointestinal fistulas.
Identifiants
pubmed: 36518984
doi: 10.1093/gastro/goac075
pii: goac075
pmc: PMC9733972
doi:
Types de publication
Journal Article
Langues
eng
Pagination
goac075Informations de copyright
© The Author(s) 2022. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University.
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