A Phase 2 interventional study of exosome and routine conventional fistulotomy in Fistula Perianal, sponsored by Tehran University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Tehran University of Medical Sciences · Phase 2, Interventional, and Treatment
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:
Participants will:
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: exosome
Procedure: routine conventional fistulotomy
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences →