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

NCT05402748 | Unknown Phase 1 DMC

• 1 other identifier: IRCT20211212053361N1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Fistula Perianal

Outcome Measures

Primary Outcomes (3)

• Safety of injected exosomes

  assessing the adverse outcomes after injection such as acute allergic reactions

  3 months

• clinical Efficacy of injected exosomes

  assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas

  3 months

• inflammatory markers

  assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.

  3 months

Study Arms (2)

exosome cases

EXPERIMENTAL

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

Other: placenta-MSCs derived exosomes

Controls

PLACEBO COMPARATOR

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

Other: placenta-MSCs derived exosomes

Interventions

placenta-MSCs derived exosomes OTHER

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.

Controls; exosome cases

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-70 years old
• Occurrence of complex perianal fistula
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran

Tehran, 1419733141, Iran

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: December 22, 2021
• Primary Completion: December 22, 2022
• Study Completion: March 22, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

IR (1)