Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula

The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex: A Non-randomized Clinical Trial.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06568653

Enrollment

Registered

2024-08-23

Start date

2024-09-15

Completion date

2025-02-15

Last updated

2024-08-23

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

Conditions

Fistula Perianal

Keywords

fistula, perianal fistula, non-Crohn's disease, exosome, mesenchymal stem cell, human placenta stem cell

Brief summary

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

Interventions

PROCEDUREexosome

human placenta mesenchymal stem cell-derived exosome

PROCEDUREroutine conventional fistulotomy

routine conventional fistulotomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* participants with complex perianal fistula * provided written informed consent

Exclusion criteria

* participants with any inflammatory bowel diseases * pregnant or lactating participants * participants with contraindications for surgery * participants with hepatitis * participants with uncontrolled diabetes * participants with alcohol or substance abuse

Design outcomes

Primary

Measure	Time frame	Description
The number of fistula openings (orifices) will be assessed before and after our intervention.	3 months	clinical improvement

Secondary

Measure	Time frame	Description
QoL questionnaire	3 months	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026