Background and objectives:
Exosomes therapy is a promising technique that can decrease the concern
related to the fate of transplanted stem cells to the fistula location.
The unique properties of mesenchymal stem cells (MSCs)-derived exosomes
can improve fistula healing because of their high ability to regulate
and modify immune responses. This project aims to examine the safety and
efficacy of implementing MSCs-exosomes in treating refractory fistulas
in inflammatory bowel disease (IBD) patients.
Methods:
The exosomes were isolated from umbilical cord-derived MSCs and
characterized using flow cytometry, western blotting, and transmittance
electron microscope (TEM). Five patients (three men and two women) with
refractory perianal Crohn’s disease with an average age of 35.4 years
old were included. The patients did not match the exclusion criteria,
and the presence of refractory fistulas was the main inclusion criteria.
These patients have their exosomes injections in the operation room. The
therapy responses of patients were assessed using physical examination,
face-to-face interviews, computerized tomography (CT) scan, and magnetic
resonance imaging (MRI) six months later.
Result:
The Following injection, patients reported a 70% improvement on
average. Two patients claimed complete healing after exosome injections,
while one patient reported no improvement and active discharge from the
fistula site. In addition, five patients reported no adverse effects,
both systemic or on the injection site.
Conclusion: Injection of exosomes extracted from MSCs shows
total safety and a satisfactory therapeutic impact, as shown in this and
other research, and could play a significant role in the treatment of
gastrointestinal fistulas in the future.