Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
Primary Purpose
Fistula Perianal
Status
Recruiting
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placenta-MSCs derived exosomes
Sponsored by
About this trial
This is an interventional basic science trial for Fistula Perianal
Eligibility Criteria
Inclusion Criteria:
- Age between 18-70 years old
- Occurrence of complex perianal fistula
- Informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, IranRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exosome cases
Controls
Arm Description
The patients whose fistula is treated by exosome (40 patients).
The patients whose fistula is treated with conventional treatment plan (40 patients).
Outcomes
Primary Outcome Measures
Safety of injected exosomes
assessing the adverse outcomes after injection such as acute allergic reactions
clinical Efficacy of injected exosomes
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
inflammatory markers
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
Secondary Outcome Measures
Full Information
NCT ID
NCT05402748
First Posted
May 25, 2022
Last Updated
November 1, 2022
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05402748
Brief Title
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
Official Title
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
March 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula Perianal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exosome cases
Arm Type
Experimental
Arm Description
The patients whose fistula is treated by exosome (40 patients).
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
The patients whose fistula is treated with conventional treatment plan (40 patients).
Intervention Type
Other
Intervention Name(s)
placenta-MSCs derived exosomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of injected exosomes
Description
assessing the adverse outcomes after injection such as acute allergic reactions
Time Frame
3 months
Title
clinical Efficacy of injected exosomes
Description
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
Time Frame
3 months
Title
inflammatory markers
Description
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-70 years old
Occurrence of complex perianal fistula
Informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
ZIP/Postal Code
1419733141
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyed Mohsen Ahmadi Tafti, Assistant Professor
Phone
+98(912)2109773
Email
smahmadit@sina.tums.ac.ir
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
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