Investigating the effect of stromal/mesenchymal stem cell-derived exosomes in patients with perianal fistula

Evaluation of the safety and efficacy of the injection of placenta-derived mesenchymal stromal/stem cell exosomes with and without priming with TNF-a in patients with complex perianal fistula without a history of CHRONS disease: A double-blinded randomized controlled trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240128060828N1

Enrollment

Registered

2024-02-02

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal Fistula. Anal fistula

Interventions

Intervention 1: Intervention group: Seton (conventional treatment method of perianal fistula) plus injection of untreated exosomes-derived placenta mesenchymal stem cells (as a control group for treat

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: sign the informed consent Patients with complex perianal fistula aged 18-75 Acceptable general health of patients based on physical tests and medical history (absence of diseases or disorders that may interfere with the treatment method evaluated in this study)

Exclusion criteria

Exclusion criteria: Patients with underlying diseases that affect the pathophysiology of perianal fistula (including IBD, rectovaginal fistula or acute sepsis, uncontrolled diabetes, and active or latent HIV, HBV, or HCV infection) Patients who need perianal surgery for reasons other than fistula Major surgeries within 28 days before admission Use of immune system modulators for reasons other than fistula in patients

Design outcomes

Primary

Measure	Time frame
Evaluation of any regional undesirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Evaluation of any systemic undsirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Degree of healing recorded by surgeon examination. Timepoint: Examination of the patient's condition during 6 months of follow-up. Method of measurement: by laboratory tests and especially during examination under anesthesia (EUA).;Degree of self satisfaction and quality of life recorded by patients. Timepoint: After the termination of the follow-up of the patient's condition. Method of measurement: By using special questionnaires for the health context of 36-Item Short Form Survey (SF-36).	—

Measure

Time frame

Evaluation of any regional undesirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Evaluation of any systemic undsirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Degree of healing recorded by surgeon examination. Timepoint: Examination of the patient's condition during 6 months of follow-up. Method of measurement: by laboratory tests and especially during examination under anesthesia (EUA).;Degree of self satisfaction and quality of life recorded by patients. Timepoint: After the termination of the follow-up of the patient's condition. Method of measurement: By using special questionnaires for the health context of 36-Item Short Form Survey (SF-36).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Vousooghi

Tehran University of Medical Sciences

dr.n.vosoughi@gmail.com+98 912 372 4378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026