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IRCT2015102824760N1 IRCT 2016-06-12 Research Chancellor, Mashhad University of Medical Sciences Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients 2016-06-19 anticipated 21 Complete https://irct.ir/trial/20835 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Rheumatoid arthritis. A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(2000000 to 3000000 cells/Kg).. 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 The Individual Participant Data Set (IPD) will be available upon request.
public Mohsen Ghoryani
BuAli Research Institute, BuAli Sq, Ferdowsi Sq
Mashhad Iran (Islamic Republic of) 9188986439 +98 51 3604 1865 ghoryanim931@mums.ac.ir Mashhad University of Medical Sciences scientific Mojgan Mohammadi
BuAli Research Institute, BuAli Square, Ferdowsi Sq
Mashhad Iran (Islamic Republic of) 9196773117 +98 51 3711 2611 mohammadimzh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Resistant RA patients to non-biological DMARDs Treated RA patients by non-biological drugs Treated RA patients by Prednisolone, Hydroxychloroquine, Sulfasalazine and Methotrexate Patients aged between 35-60 years Refractory RA patients with no other rheumatologic disorders and inflammatory diseases 35 years 60 years Both Non-resistant RA patients to non-biological DMARDs M05 Diseases of the musculoskeletal system and connective tissue Treatment - Other A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(2000000 to 3000000 cells/Kg). Interleukin-1. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: pg/ml using ELISA assay. TNF-alpha. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: pg/ml using ELISA assay. Interleukin-4. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: pg/ml using ELISA assay. Interleukin-10. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: pg/ml using ELISA assay. TGF-beta. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Frequency and the intensity of stained cells in the ELISPOT assay. Interleukin-17. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: pg/ml using ELISA assay. T-bet transcription factor. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. GATA3 transcription factor. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. FOXP3 transcription factor. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. ROR-gamma T transcription factor. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. T helper cells. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. Regulatory T cells. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. Th17. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. Disease activity score (DAS). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Clinical and laboratory findings. Visual analogue scale (VAS). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The amount of pain that a patient feels. Erythrocyte sedimentation rate(ESR). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Erythrocyte sedimentation rate in millimeters. C-reactive protein (CRP). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Latex agglutination test. Rheumatoid factor(RF). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: Latex agglutination test. Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: ELISA test. TNF-α. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. IL-17A. Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: The copy number of desired gene using RT-PCR assay. Anaphylaxis. Timepoint: After IV infusion of MSCs. Method of measurement: Clinical manifestations, hypotension and hypoglycemia. Differentiation of MSCs to unwanted cells. Timepoint: After IV infusion of MSCs. Method of measurement: Clinical manifestations. Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr Research Chancellor, Mashhad University of Medical Sciences Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr Approved 2015-11-21 Ethics committee of Mashhad University of Medical Sciences Qoreishi Bulding, Daneshgah St Mashhad Razavi Khorasan Iran (Islamic Republic of) Approved 2023-05-20 Ethics committee of Mashhad University of Medical Sciences Qoreishi Bulding, Daneshgah St Mashhad Razavi Khorasan Iran (Islamic Republic of)