Human Placenta Mesenchymal Stem Cells Derived Exosomes In... | NCT06568653

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

NCT06568653

Sponsor

Tehran University of Medical Sciences

Status

Not yet recruiting

Last Update Posted

Aug 23, 2024Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Fistula Perianal

Interventions

exosome
routine conventional fistulotomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2024Estimated

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

Feb 15, 2025Estimated

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Aug 22, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2024

Last Update Posted Date

Aug 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental		Procedure: exosome
control	Active Comparator		Procedure: routine conventional fistulotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exosome	Procedure	human placenta mesenchymal stem cell-derived exosome	intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
QoL questionnaire	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	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005402	Fistula

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided