The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are:
* Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants? * Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula.
Participants will:
* Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone. * Visit the clinic the week after surgery and then every 4 weeks for checkups and tests
participants with complex perianal fistula
provided written informed consent
participants with any inflammatory bowel diseases
pregnant or lactating participants
participants with contraindications for surgery
participants with hepatitis
Parallel
exosome
Procedure/Surgeryhuman placenta mesenchymal stem cell-derived exosome
routine conventional fistulotomy
Procedure/Surgeryroutine conventional fistulotomy
The number of fistula openings (orifices) will be assessed before and after our intervention.
clinical improvement
QoL questionnaire
quality of life improvement (before and after intervention) assessed by Persian (Farsi) version of the QoLAF (quality of life in patients with anal fistula) questionnaire
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This trial is not recruiting at the moment. You can still explore other options:
