NCT06568653

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

August 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 22, 2024

Last Update Submit

August 22, 2024

Conditions

Fistula Perianal

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • The number of fistula openings (orifices) will be assessed before and after our intervention.

    clinical improvement

    3 months

Secondary Outcomes (1)

  • QoL questionnaire

    3 months

Study Arms (2)

intervention

EXPERIMENTAL
Procedure: exosome

control

ACTIVE COMPARATOR
Procedure: routine conventional fistulotomy

Interventions

exosomePROCEDURE

human placenta mesenchymal stem cell-derived exosome

intervention
routine conventional fistulotomyPROCEDURE

routine conventional fistulotomy

control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants with complex perianal fistula
  • provided written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

August 23, 2024

Study Start

September 15, 2024

Primary Completion

November 15, 2024

Study Completion

February 15, 2025

Last Updated

August 23, 2024

Record last verified: 2024-07