Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05402748

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Fistula Perianal	Other: placenta-MSCs derived exosomes	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula

Actual Study Start Date :

Dec 22, 2021

Anticipated Primary Completion Date :

Jul 22, 2022

Anticipated Study Completion Date :

Aug 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exosome cases The patients whose fistula is treated by exosome (40 patients).	Other: placenta-MSCs derived exosomes 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.
Placebo Comparator: Controls The patients whose fistula is treated with conventional treatment plan (40 patients).	Other: placenta-MSCs derived exosomes 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.

Arm

Intervention/Treatment

Experimental: exosome cases

The patients whose fistula is treated by exosome (40 patients).

Other: placenta-MSCs derived exosomes

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.

Placebo Comparator: Controls

The patients whose fistula is treated with conventional treatment plan (40 patients).

Other: placenta-MSCs derived exosomes

Outcome Measures

Primary Outcome Measures

Safety of injected exosomes [3 months]
assessing the adverse outcomes after injection such as acute allergic reactions
clinical Efficacy of injected exosomes [3 months]
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
inflammatory markers [3 months]
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran	Tehran		Iran, Islamic Republic of	1419733141

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmadi tafti, assistant professor, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05402748

Other Study ID Numbers:

IRCT20211212053361N1

First Posted:

Jun 2, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Fistula

Fistula

Study Results

No Results Posted as of Jun 2, 2022