Fistula PerianalPhase 2NCT06568653
Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
A Phase 2 study testing exosome and routine conventional fistulotomy in people with Fistula Perianal, run by Tehran University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fistula Perianal
- What is being tested?
- exosome and routine conventional fistulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants with complex perianal fistula
- provided written informed consent
Who cannot join
- 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
About this study
Official title: 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.
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.
Read more
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
- Conditions
- Fistula Perianal
- Being tested
- exosome, routine conventional fistulotomy
- Keywords
- fistula, perianal fistula, non-Crohn's disease, exosome, mesenchymal stem cell, human placenta stem cell
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomeProcedure or surgery
human placenta mesenchymal stem cell-derived exosome
routine conventional fistulotomyProcedure or surgery
routine conventional fistulotomy
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Procedure: exosome |
| control | Active comparator | Not described Receives: Procedure: routine conventional fistulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of fistula openings (orifices) will be assessed before and after our intervention.
clinical improvement
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula PerianalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568653
- Sponsor's protocol ID
- IR.TUMS.IKHC.REC.1403.113
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06568653
- Acronym / sponsor ID
- IR.TUMS.IKHC.REC.1403.113
- Conditions
- Fistula Perianal
- Keywords
- fistula, perianal fistula, non-Crohn's disease, exosome, mesenchymal stem cell, human placenta stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: exosome |
| control | Active comparator | Procedure: routine conventional fistulotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants with complex perianal fistula
- provided written informed consent
Key exclusion criteria (6 listed)
- participants with any inflammatory bowel diseases
- pregnant or lactating participants
- participants with contraindications for surgery
- participants with hepatitis
- participants with uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomehuman placenta mesenchymal stem cell-derived exosome | Procedure or surgery | intervention |
| routine conventional fistulotomyroutine conventional fistulotomy | Procedure or surgery | control |
Primary outcome
The number of fistula openings (orifices) will be assessed before and after our intervention.
Time frame: 3 months
clinical improvement
1 secondary outcome
QoL questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exosome and routine conventional fistulotomy in people with Fistula Perianal, run by Tehran University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of fistula openings (orifices) will be assessed before and after our intervention. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.