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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
human placenta mesenchymal stem cell-derived exosome
routine conventional fistulotomy
The number of fistula openings (orifices) will be assessed before and after our intervention.
clinical improvement
Time frame: 3 months
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
Time frame: 3 months
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