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IRCT20240128060828N1 IRCT 2024-02-02 Tehran University of Medical Sciences Investigating the effect of stromal/mesenchymal stem cell-derived exosomes in patients with perianal fistula Evaluation of the safety and efficacy of the injection of placenta-derived mesenchymal stromal/stem cell exosomes with and without priming with TNF‐α in patients with complex perianal fistula without a history of CHRONS disease: A double-blinded randomized controlled trial 2024-02-20 anticipated 30 Complete https://irct.ir/trial/75202 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: This study will be conducted as a phase 1 randomized controlled clinical trial in order to check the safety and effectiveness of the treatment method of this study in three groups and with the inclusion of 30 patients (10 patients in each group). During this study, blinding will be done in a double-blind manner, for this purpose, the specialist doctor and the patient will not know about the treatment method used. The groups will be as follows: 1- The first group will receive the conventional seton along with normal saline injection as a control group for the exosome groups. 2- The second group will receive seton plus injection of untreated exosomes (as a control group for treated exosomes). The number of injections in this group will be 1 time. 3- The third group will receive seton plus an injection of treated exosomes. The number of injections in this group will be 1 time, Randomization description: RANDBETWEEN function of Excel software was used for randomization. In short, cells that contain patients with numbers 1 to 30 with the RANDBETWEEN function [fx = RANDBETWEEN(1, 30)] are selected, and patients are randomly assigned a number based on the mentioned groups. In this way, random numbers 1 to 10 are in the first group, numbers 10 to 20 are in the second group, and numbers 20 to 30 are in the third group, Blinding description: During this study, the data analyst and the clinician will be blinded. The clinical doctor only received the vial of liquid without the description label, and the patient will be unaware of the type of injected substance (therapeutic or control substance). 1 Perianal Fistula. Intervention 1: Intervention group: Seton (conventional treatment method of perianal fistula) plus injection of untreated exosomes-derived placenta mesenchymal stem cells (as a control group for treated exosomes). The number of injections in this group will be 1 time. Intervention 2: Intervention group: Seton plus injection of treated exosomes-derived placenta mesenchymal stem cells. The number of injections in this group will be 1 time. Intervention 3: Control group: conventional seton along with normal saline (as a control group for exosome groups). In order to reduce the difference between the treatment and control groups, it is also necessary to inject normal saline so that the therapeutic effect of the new combined approach can be relied upon. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the study is in the preliminary stage and if the study is done, the mentioned sections will be added.
public Nasim Vousooghi
North Kargar Ave.
Tehran Iran (Islamic Republic of) 1417933431 +98 912 372 4378 dr.n.vosoughi@gmail.com Tehran University of Medical Sciences scientific Nasim Vousooghi
North Kargar Ave.
Tehran Iran (Islamic Republic of) 1417933431 +98 912 372 4378 dr.n.vosoughi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) sign the informed consent Patients with complex perianal fistula aged 18-75 Acceptable general health of patients based on physical tests and medical history (absence of diseases or disorders that may interfere with the treatment method evaluated in this study) 18 years 75 years Both Patients with underlying diseases that affect the pathophysiology of perianal fistula (including IBD, rectovaginal fistula or acute sepsis, uncontrolled diabetes, and active or latent HIV, HBV, or HCV infection) Patients who need perianal surgery for reasons other than fistula Major surgeries within 28 days before admission Use of immune system modulators for reasons other than fistula in patients K60.3 Anal fistula Treatment - Other Treatment - Other Treatment - Other Intervention group: Seton (conventional treatment method of perianal fistula) plus injection of untreated exosomes-derived placenta mesenchymal stem cells (as a control group for treated exosomes). The number of injections in this group will be 1 time. Intervention group: Seton plus injection of treated exosomes-derived placenta mesenchymal stem cells. The number of injections in this group will be 1 time. Control group: conventional seton along with normal saline (as a control group for exosome groups). In order to reduce the difference between the treatment and control groups, it is also necessary to inject normal saline so that the therapeutic effect of the new combined approach can be relied upon. Evaluation of any regional undesirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion. Evaluation of any systemic undsirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion. Degree of healing recorded by surgeon examination. Timepoint: Examination of the patient's condition during 6 months of follow-up. Method of measurement: by laboratory tests and especially during examination under anesthesia (EUA). Degree of self satisfaction and quality of life recorded by patients. Timepoint: After the termination of the follow-up of the patient's condition. Method of measurement: By using special questionnaires for the health context of 36-Item Short Form Survey (SF-36). Tehran University of Medical Sciences Approved 2024-01-20 Research Ethics Committees of The Institute of Pharmaceutical Sciences -Tehran University of Medical North Kargar Ave. Tehran Tehran Iran (Islamic Republic of)