Fistula PerianalPhase 1/2NCT05402748
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
A Phase 1/2 study testing placenta-MSCs derived exosomes in people with Fistula Perianal, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Study aim: Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in… 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?
- placenta-MSCs derived exosomes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 22 Dec 2021to 22 Mar 2023
- Phase
- Phase 1/2
- 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
- Age between 18-70 years old
- Occurrence of complex perianal fistula
- Informed consent
Who cannot join
- Active inflammatory bowel disease
- Synchronous perianal abscess
- Alcohol,narcotic and stimulant consumption
- Having active Hepatitis B,C,HIV or TB
- Peregnancy and lactation
- Uncontrolled diabetes mellitus
- Evidence of surgical contraindication
- Psychological disorders and noncooperative patient
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
Tehran, 1419733141
Seyed Mohsen Ahmadi Tafti, Assistant Professor, +98(912)2109773, smahmadit@sina.tums.ac.ir
About this study
Study aim:
Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment
Read more
Participants/Inclusion and exclusion criteria:
inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient
Intervention groups:
Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.
Design:
this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.
Settings and conduct:
Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.
Main outcome variables:
Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin
- Conditions
- Fistula Perianal
- Being tested
- placenta-MSCs derived exosomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placenta-MSCs derived exosomesOther
Exosomes are extracellular vesicles that are 30 to 150 nm in diameter. these vesicles are secreted from various cells. Mesenchymal stem cells exhibit immunomodulatory and anti- inflammatory properties by the use of paracrine effects. Exosomes as a vehicle for signaling, are responsible for a major part of cell to cell signaling. The preclinical animal studies manifested high safety and efficacy for MSC derived exosome treatment on various fistulas and inflammatory bowel disease. In this study we aimed to evaluate the safety and efficacy of Placenta-MSCs derived exosomes in treatment of patients with complex preanal fistula (non-crohn's) in phase I and II of clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| exosome cases | Experimental | The patients whose fistula is treated by exosome (40 patients). Receives: Other: placenta-MSCs derived exosomes |
| Controls | Placebo comparator | The patients whose fistula is treated with conventional treatment plan (40 patients). Receives: Other: placenta-MSCs derived exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of injected exosomes
assessing the adverse outcomes after injection such as acute allergic reactions
Measured: 3 months
clinical Efficacy of injected exosomes
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
Measured: 3 months
inflammatory markers
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
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 posted2 Jun 2022
- Study start22 Dec 2021
- Primary completion22 Dec 2022 (estimated)
- Study completion22 Mar 2023 (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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmadi tafti, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402748
- Sponsor's protocol ID
- IRCT20211212053361N1
- Status last verified
- Nov 2022
- First submitted
- 25 May 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
- ClinicalTrials.gov ID
- NCT05402748
- Acronym / sponsor ID
- IRCT20211212053361N1
- Conditions
- Fistula Perianal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 22 Mar 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
Study aim:
Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment
Participants/Inclusion and exclusion criteria:
inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient
Intervention groups:
Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.
Design:
this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.
Settings and conduct:
Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.
Main outcome variables:
Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exosome cases | Experimental | Other: placenta-MSCs derived exosomesThe patients whose fistula is treated by exosome (40 patients). |
| Controls | Placebo comparator | Other: placenta-MSCs derived exosomesThe patients whose fistula is treated with conventional treatment plan (40 patients). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-70 years old
- Occurrence of complex perianal fistula
- Informed consent
Key exclusion criteria (8 listed)
- Active inflammatory bowel disease
- Synchronous perianal abscess
- Alcohol,narcotic and stimulant consumption
- Having active Hepatitis B,C,HIV or TB
- Peregnancy and lactation
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 |
|---|---|---|
| placenta-MSCs derived exosomesExosomes are extracellular vesicles that are 30 to 150 nm in diameter. these vesicles are secreted from various cells. Mesenchymal stem cells exhibit immunomodulatory and anti- inflammatory properties by the use of paracrine effects. Exosomes as a vehicle for signaling, are responsible for a major part of cell to cell signaling. The preclinical animal studies manifested high safety and efficacy for MSC derived exosome treatment on various fistulas and inflammatory bowel disease. In this study we aimed to evaluate the safety and efficacy of Placenta-MSCs derived exosomes in treatment of patients with complex preanal fistula (non-crohn's) in phase I and II of clinical trial. | Other | Controls, exosome cases |
Primary outcome
Safety of injected exosomes
Time frame: 3 months
assessing the adverse outcomes after injection such as acute allergic reactions
clinical Efficacy of injected exosomes
Time frame: 3 months
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
inflammatory markers
Time frame: 3 months
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing placenta-MSCs derived exosomes in people with Fistula Perianal, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 8 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of injected exosomes (time frame: 3 months). The study lists 3 primary outcomes in all. 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 2 Nov 2022.