Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
NCT ID: NCT06568653
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-09-15
2025-02-15
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intervention
exosome
human placenta mesenchymal stem cell-derived exosome
control
routine conventional fistulotomy
routine conventional fistulotomy
Interventions
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exosome
human placenta mesenchymal stem cell-derived exosome
routine conventional fistulotomy
routine conventional fistulotomy
Eligibility Criteria
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Inclusion Criteria
* provided written informed consent
Exclusion Criteria
* pregnant or lactating participants
* participants with contraindications for surgery
* participants with hepatitis
* participants with uncontrolled diabetes
* participants with alcohol or substance abuse
18 Years
70 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Other Identifiers
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IR.TUMS.IKHC.REC.1403.113
Identifier Type: -
Identifier Source: org_study_id
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