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IRCT20200809048342N2 IRCT 2022-05-21 Shahid Beheshti University of Medical Sciences Therapeutic effect of stem cell secretions on Crohn's disease Clinical trial Phase II (proof of concept), three arms study on amelioration of peri-anal fistula in Crohn’s disease with Warton jelly Mesenchymal Stem Cells and its Secretome 2021-09-23 anticipated 10 Complete https://irct.ir/trial/59653 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Because we are looking for study groups with equal sample size, limited randomization such as block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps us in the intermediate analyzes during the sampling process, the number of samples assigned to each of the study groups is equal. Permuted block randomization with block size 3. Participants were assigned to three groups treatment including MSc, exosome and placebo using the block randomization method (triple blocks with equal volume). This ensures balance in the number of groups. In this study, due to the existence of three treatment groups, for 3 blocks (A: Placebo, B: MSc, C: exosome) there will be ten different manners. Randomized selection will be carried out each time by Random allocation software as follow: -ABC -BAC -ABC -BCA -BCA -CAB -CAB -CBA -BAC -BAC. 2 Patients with peri-anal fistula in Crohn’s disease. Intervention 1: Intervention group: patients receive MSC. Each patient will receive 3 injections (1 × 106 cells / Kg) first injection will be locally and then next two administrations intravenously weekly. Mesenchymal stem cells (MSCs) are multipotent adult cells with self-renewing capacities. MSCs display specific properties, such as the ability to repair damaged tissues, resulting in optimal candidates for cell therapy against degenerative diseases. In addition to the reparative functions of MSCs, evidence shows that these cells have potent immunomodulatory and anti-inflammatory properties. Therefore, MSCs are potential tools for treating inflammation-related diseases. Intervention 2: Control group:patients will receive placebo. Intervention 3: Intervention group: secretome and MSC-secreted extracellular vesicles (Exosome). Each patient will receive 3 injections the first injection will be locally and then the next two administrations intravenously weekly. Mesenchymal stem cells (MSCs) have become key cells in therapy because of their immunosuppressive function and anti-inflammatory effects. MSCs exert immunosuppressive effects through direct contact or paracrine action. The paracrine functions of MSCs are at least partially mediated by exosomes, which are membrane vesicles, carrying abundant proteins, nucleic acids and other active molecules. MSC-exos have heterogeneity. The exosomes from different donors, tissues generations of MSCs carry different bioactive molecules. Exosomes derived from MSCs (MSC-exos) carry immunomodulatory effectors or transmit active signal molecules to regulate the biological activities of immune cells and thus mediating immune suppression. 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 There is no further information
public Shabnam Shahrokh, Fakhrossadat Anaraki
Aerabi Ave., Tabnak Str., Evin
tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2517 shabnamshahrokh@gmail.com Shahid Beheshti University of Medical Sciences scientific Kaveh Baghaei, Massoud Soleimani
Aerabi Ave., Tabnak Str., Evin
Tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2517 kavehbaghaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Males or females between 18-75 years old with a clinically confirmed diagnosis of Crohn’s disease Medical therapy resistant perianal fistula Mild to moderate Crohn’s disease activity index 18 years 75 years Both Any reasons which reported as side effect of interventions If participants would like to leave the trials for any reasons Active infectious disease Pregnant patient Liver or kidney insufficiency Underlying malignancy Uncontrolled diabetes History of chemoradiotherapy Patients with immunodeficiency Severe Crohn’s disease activity index K50.813 Crohn's disease of both small and large intestine with fistula Treatment - Other Placebo Treatment - Other Intervention group: patients receive MSC. Each patient will receive 3 injections (1 × 106 cells / Kg) first injection will be locally and then next two administrations intravenously weekly. Mesenchymal stem cells (MSCs) are multipotent adult cells with self-renewing capacities. MSCs display specific properties, such as the ability to repair damaged tissues, resulting in optimal candidates for cell therapy against degenerative diseases. In addition to the reparative functions of MSCs, evidence shows that these cells have potent immunomodulatory and anti-inflammatory properties. Therefore, MSCs are potential tools for treating inflammation-related diseases. Control group:patients will receive placebo. Intervention group: secretome and MSC-secreted extracellular vesicles (Exosome). Each patient will receive 3 injections the first injection will be locally and then the next two administrations intravenously weekly. Mesenchymal stem cells (MSCs) have become key cells in therapy because of their immunosuppressive function and anti-inflammatory effects. MSCs exert immunosuppressive effects through direct contact or paracrine action. The paracrine functions of MSCs are at least partially mediated by exosomes, which are membrane vesicles, carrying abundant proteins, nucleic acids and other active molecules. MSC-exos have heterogeneity. The exosomes from different donors, tissues generations of MSCs carry different bioactive molecules. Exosomes derived from MSCs (MSC-exos) carry immunomodulatory effectors or transmit active signal molecules to regulate the biological activities of immune cells and thus mediating immune suppression. Total number of soft/liquid stools in the last 7 days. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Flatus. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score. IL-10. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Blood test. TNFα. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Blood test. Liquid secretion. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score. Solid secretion. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score. Pad. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score. Lifestyle. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score. Abdominal pain. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). General well-being. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Anti-diarrhea drug use. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Abdominal mass. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Hematocrit. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Arthritis/arthralgiasIritis/uveitis. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Erythema nodosum. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Pyoderma gangrenosum, or apthous stomatitis. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Anal fissure, fistula. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Or abscess, Fever/temperature > 100°F/37.8°C. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index). Shahid Beheshti University of Medical Sciences Approved 2021-05-08 Ethics committee of Research Institute For Gastroenterology & Liver Diseases- Shahid Beheshti Univer Aerabi Ave., Tabnak Str., Evin, Tehran tehran Tehran Iran (Islamic Republic of)