Safety and efficacy of exosome Injection in perianal fistula

Safety and efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211212053361N1

Enrollment

Registered

2021-12-22

Start date

2021-12-22

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Complex perianal fistula.

Interventions

Intervention group:.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18-70 years old Complex perianal fistula Informed consent

Exclusion criteria

Exclusion criteria: Active inflammatory bowel disease Synchronous perianalabcess Alcohol, narcotic and stimulant consumption Having active hepatitis B,C, HIV or TB Pregnancy and lactation Uncontrolled diabetes mellitus Evidence of surgical contraindication Psychological disorders and noncooperative pateint

Design outcomes

Primary

Measure	Time frame
Discharge amount. Timepoint: before and during and 12 weeks after the study. Method of measurement: due to pateint's history.;External orifice reepithelialisation. Timepoint: before and 12 weeks after the study. Method of measurement: clinical examination and MRI.;Inflammation and abcess larger than 2 cm. Timepoint: before and 12 weeks after the study. Method of measurement: MRI.;Quality of life questionair score. Timepoint: before and 12 weeks after the study. Method of measurement: Quality of life questionair in perianal fistula patients.	—

Measure

Time frame

Discharge amount. Timepoint: before and during and 12 weeks after the study. Method of measurement: due to pateint's history.;External orifice reepithelialisation. Timepoint: before and 12 weeks after the study. Method of measurement: clinical examination and MRI.;Inflammation and abcess larger than 2 cm. Timepoint: before and 12 weeks after the study. Method of measurement: MRI.;Quality of life questionair score. Timepoint: before and 12 weeks after the study. Method of measurement: Quality of life questionair in perianal fistula patients.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohsen Ahmadi Tafti

Tehran University of Medical Sciences

smahmadit@sina.tums.ac.ir+98 21 6658 1657

Outcome results

None listed

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