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Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients

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History
# Registration date Revision Id
3 2023-08-08, 1402/05/17 274955
2 2023-05-01, 1402/02/11 270949
1 2016-06-12, 1395/03/23 20835
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  • Protocol summary

    1. Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular immune response in refractory rheumatoid arthritis patients. 2. Design: This study is a phase 1 clinical trial. 3. Setting and conduct: Autologous bone marrow derived mesenchymal stem cells will be obtained by bone marrow aspiration and will be cultured in Minimum Essential Medium-Alpha for 4 weeks in standard clean room and then transfused to RA patients intravenously. 4. Participants including major eligibility criteria: 21 refractory rheumatoid arthritis patients who show resistance to non biological DMARDs after 6 to 12 months will be enrolled in this study. 5. Intervention: A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(2000000 to 3000000 cells/Kg) to patients with resistance to non-biological DMARDs. 6. Main outcome measures(variables): Finding of mesenchymal stem cell therapy effects on the cellular immune responses.
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    1- اهداف: بررسی اثر درمان با سلول های بنیادی مزانشیمال بر پاسخ های ایمنی سلولی در بیماران آرتریت روماتوئید مقاوم به درمان. 2- طراحی: این مطالعه، کارآزمایی بالینی فاز 1 است. 3- نحوه انجام: سلول های بنیادی مزانشیمال اتولوگ استخراج شده از مغز استخوان، از طریق آسپیراسیون مغز استخوان بدست آمده و به مدت 4 هفته در محیط Minimum Essential Medium-Alpha در اتاق تمیز استاندارد کشت شده و سپس به بیماران آرتریت روماتوئید مقاوم به درمان از طریق وریدی تزریق خواهند شد. 4- شرکت کنندگان شامل شرایط ورود و خروج اصلی: 21 بیمار آرتریت روماتوئید مقاوم به درمان که به DMARD های غیر بیولوژیک بعد از 6 الی 12 ماه مقاومت نشان می دهند به این مطالعه وارد خواهند شد. 5- مداخلات: یک تزریق داخل وریدی سلول های بنیادی مزانشیمال اتولوگ استخراج شده از مغز استخوان(2000000 الی 3000000 سلول به ازای هر کیلوگرم) به بیماران مقاوم به DMARD های غیر بیولوژیک. 6- متغیر های پیامد اصلی: یافتن اثر درمان با سلول های بنیادی مزانشیمال بر پاسخ های ایمنی سلولی.
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    empty
    Evaluation of mesenchymal stem cell therapy effects on cellular immune response in refractory rheumatoid arthritis patients.
    empty
    بررسی اثر درمان با سلول های بنیادی مزانشیمال بر پاسخ های ایمنی سلولی در بیماران آرتریت روماتوئید مقاوم به درمان.
    empty
    This study is a single-arm clinical trial in which a single intravenous dose of autologous bone marrow derived mesenchymal stem cells will be administred to 21 patinets with refractory rheumatoid arthritis.
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    این مطالعه یک کارآزمایی بالینی یک گروهه است که در آن یک دوز تزریق داخل وریدی سلول های بنیادی مزانشیمال اتولوگ استخراج شده از مغز استخوان به 21 بیمار آرتریت روماتوئید مقاوم به درمان تجویز خواهد شد.
    empty
    Autologous bone marrow derived mesenchymal stem cells will be obtained by bone marrow aspiration and will be cultured in Minimum Essential Medium-Alpha for 4 weeks in standard clean room and then transfused to RA patients intravenously.
    empty
    سلول های بنیادی مزانشیمال اتولوگ استخراج شده از مغز استخوان، از طریق آسپیراسیون مغز استخوان بدست آمده و به مدت 4 هفته در محیط Minimum Essential Medium-Alpha در اتاق تمیز استاندارد کشت شده و سپس به بیماران آرتریت روماتوئید مقاوم به درمان از طریق وریدی تزریق خواهند شد.
    empty
    Twenty one refractory rheumatoid arthritis patients who show resistance to non biological DMARDs after 6 to 12 months will be enrolled in this study. Non-resistant RA patients to non-biological DMARDs will not be enrolled in this study.
    empty
    بیست و یک بیمار آرتریت روماتوئید مقاوم به درمان که به DMARD های غیر بیولوژیک بعد از 6 الی 12 ماه مقاومت نشان می دهند به این مطالعه وارد خواهند شد. بیماران آرتریت روماتوئید غیر مقاوم به DMARD های غیر بیولوژیک به این مظالعه وارد نخواهند شد.
    empty
    A single intravenous administration of autologous bone marrow derived mesenchymal stem cells (2000000 to 3000000 cells/Kg) to refractory rheumatoid arthritis patients with resistance to non-biological DMARDs
    empty
    گروه دریافت کننده یک تزریق داخل وریدی سلول های بنیادی مزانشیمال اتولوگ استخراج شده از مغز استخوان (2000000 الی 3000000 سلول به ازای هر کیلوگرم) به بیماران آرتریت روماتوئید مقاوم به درمان مقاوم به DMARD های غیر بیولوژیک.
    empty
    Finding of mesenchymal stem cell therapy effects on the cellular immune responses.
    empty
    یافتن اثر درمان با سلول های بنیادی مزانشیمال بر پاسخ های ایمنی سلولی.

  • General information

    empty
    Two primary outcomes including gene expression of TNF-α and IL-17A were added to the study which will be evaluated using RT-PCR assay.
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    دو پیامد اولیه شامل TNF-α و IL-17A به مطالعه اضافه شده اند که به روش RT-PCR بررسی خواهند شد.
    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
    بیماران آرتریت روماتوئید مقاوم به DMARD های غیر بیولوژیک
    بیماران آرتریت روماتوئید تحت درمان با داروهای غیر بیولوژیک
    بیماران آرتریت روماتوئید تحت درمان با پردنیزولون، هیدروکسی کلروکین، سولفاسالازین و متوتروکسات
    بیماران در محدوده سنی 60-35 سال
    بیماران آرتریت روماتوئید مقاوم به درمان بدون سایر اختلالات روماتولوژیک و بیماری های التهابی
    Non-resistant RA patients to non-biological DMARDs
    بیماران آرتریت روماتوئید غیر مقاوم به DMARD های غیر بیولوژیک.
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  • Ethics committees

    #1
    2015-11-21, 1394/08/30
    2023-05-20, 1402/02/30
    IR.MUMS.REC.1394.529
    IR.MUMS.REC.1402.076

  • Primary outcomes

    #1
    empty
    TNF-α
    empty
    TNF-α
    empty
    Before intervention and after 1, 6, 12 months follow up
    empty
    قبل مداخله و بعد از 1، 6 و 12 ماه پایش
    empty
    The copy number of desired gene using RT-PCR assay
    empty
    تعداد نسخه های تولید شده از ژن مورد نظر با تکنیک RT-PCR
    #2
    empty
    IL-17A
    empty
    IL-17A
    empty
    Before intervention and after 1, 6, 12 months follow up
    empty
    قبل مداخله و بعد از 1، 6 و 12 ماه پایش
    empty
    The copy number of desired gene using RT-PCR assay
    empty
    تعداد نسخه های تولید شده از ژن مورد نظر با تکنیک RT-PCR

  • Recruitment centers

    #1
    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا(ع)
    Full name of responsible person - English: ِDr. Zhale shariati sarabi
    Full name of responsible person - Persian: دکتر ژاله شریعتی سرابی
    Street address - English: Ebne Sina Ave, Emam Reza Sq
    Street address - Persian: میدان امام رضا(ع)، خیابان ابن سینا
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا(ع)
    Full name of responsible person - English: ِDr. Zhale shariati sarabi
    Full name of responsible person - Persian: دکتر ژاله شریعتی سرابی
    Street address - English: Ebne Sina Ave, Emam Reza Sq
    Street address - Persian: میدان امام رضا(ع)، خیابان ابن سینا
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3854 3041
    Fax:
    Email: ShariatiJ@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Research Chancellor, Mashhad University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Mojgan Mohammadi
    Full name of responsible person - Persian: دکتر مژگان محمدی
    Street address - English: BuAli research institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research Chancellor, Mashhad University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Dr. Mojgan Mohammadi
    Full name of responsible person - Persian: دکتر مژگان محمدی
    Street address - English: BuAli research institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9196773117
    Phone: +98 51 3711 2611
    Fax:
    Email: Mohammadimzh@mums.ac.ir
    Web page address:
    empty
    75
    empty
    Public
    empty
    Domestic
    empty
    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr
    Name of organization / entity - Persian: معاونت علمی و فناوری ریاست جمهوری، ستاد توسعه علوم و فناوری های سلول بنیادی
    Full name of responsible person - English: Dr. Amir Ali Hamidieh
    Full name of responsible person - Persian: دکتر امیر علی حمیدیه
    Street address - English: No 21, Ladan Alley, North Sheikh Bahayee St, MollaSadra St, Vanak Sq
    Street address - Persian: میدان ونک، خیابان ملاصدرا، خیابان شیخ بهایی شمالی، کوچه لادن، پلاک21
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr
    Name of organization / entity - Persian: معاونت علمی و فناوری ریاست جمهوری، ستاد توسعه علوم و فناوری های سلول بنیادی
    Full name of responsible person - English: Dr. Amir Ali Hamidieh
    Full name of responsible person - Persian: دکتر امیر علی حمیدیه
    Street address - English: No 21, Ladan Alley, North Sheikh Bahayee St, MollaSadra St, Vanak Sq
    Street address - Persian: میدان ونک، خیابان ملاصدرا، خیابان شیخ بهایی شمالی، کوچه لادن، پلاک21
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1415515650
    Phone: +98 21 8353 2373
    Fax:
    Email: info@stemcell.isti.ir
    Web page address:
    empty
    25
    empty
    Public
    empty
    Domestic
    empty
    Other

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mohsen Ghoryani
    Full name of responsible person - Persian: محسن قریانی
    Position - English: Ph.D student in Immunology
    Position - Persian: دانشجوی دکترای تخصصی ایمونولوژی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli Research Institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9188986439
    Phone: +98 51 3604 1865
    Mobile: +98 915 932 6650
    Fax: +98 51 3711 2596
    Email: ghoryanim931@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mohsen Ghoryani
    Full name of responsible person - Persian: محسن قریانی
    Position - English: Ph.D in Immunology
    Position - Persian: دکترای تخصصی ایمونولوژی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli Research Institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9188986439
    Phone: +98 51 3604 1865
    Mobile: +98 915 932 6650
    Fax: +98 51 3711 2596
    Email: ghoryanim931@mums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mojgan Mohammadi
    Full name of responsible person - Persian: مژگان محمدی
    Position - English: Ph.D
    Position - Persian: Ph.D
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli Research Institute, BuAli Square, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9196773117
    Phone: +98 51 3711 2611
    Mobile: +98 913 242 8291
    Fax: +98 51 3711 2596
    Email: mohammadimzh@mums.ac.ir; mozhganmohammadi69@yahoo.co.uk
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mojgan Mohammadi
    Full name of responsible person - Persian: مژگان محمدی
    Position - English: Ph.D
    Position - Persian: Ph.D
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli Research Institute, BuAli Square, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9196773117
    Phone: +98 51 3711 2611
    Mobile: +98 913 242 8291
    Fax: +98 51 3711 2596
    Email: mohammadimzh@mums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mohsen Ghoryani
    Full name of responsible person - Persian: محسن قریانی
    Position - English: Ph.D student in Immunology
    Position - Persian: دانشجوی دکترای تخصصی ایمونولوژی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli research institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9188986439
    Phone: +98 51 3604 1865
    Mobile: +98 915 932 6650
    Fax: +98 51 3711 2596
    Email: ghoryanim931@mums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mashhad University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
    Full name of responsible person - English: Mohsen Ghoryani
    Full name of responsible person - Persian: محسن قریانی
    Position - English: Ph.D in Immunology
    Position - Persian: دکترای تخصصی ایمونولوژی
    Latest degree: phd
    Area of specialty/work: 12
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: BuAli research institute, BuAli Sq, Ferdowsi Sq
    Street address - Persian: میدان فردوسی، میدان بوعلی، پژوهشکده بوعلی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9188986439
    Phone: +98 51 3604 1865
    Mobile: +98 915 932 6650
    Fax: +98 51 3711 2596
    Email: ghoryanim931@mums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    The Individual Participant Data Set (IPD) will be available upon request.
    empty
    مجموعه اطلاعات بیماران متعاقب ارسال درخواست قابل دسترسی خواهد بود.

Protocol summary

Study aim
Evaluation of mesenchymal stem cell therapy effects on cellular immune response in refractory rheumatoid arthritis patients.
Design
This study is a single-arm clinical trial in which a single intravenous dose of autologous bone marrow derived mesenchymal stem cells will be administred to 21 patinets with refractory rheumatoid arthritis.
Settings and conduct
Autologous bone marrow derived mesenchymal stem cells will be obtained by bone marrow aspiration and will be cultured in Minimum Essential Medium-Alpha for 4 weeks in standard clean room and then transfused to RA patients intravenously.
Participants/Inclusion and exclusion criteria
Twenty one refractory rheumatoid arthritis patients who show resistance to non biological DMARDs after 6 to 12 months will be enrolled in this study. Non-resistant RA patients to non-biological DMARDs will not be enrolled in this study.
Intervention groups
A single intravenous administration of autologous bone marrow derived mesenchymal stem cells (2000000 to 3000000 cells/Kg) to refractory rheumatoid arthritis patients with resistance to non-biological DMARDs
Main outcome variables
Finding of mesenchymal stem cell therapy effects on the cellular immune responses.

General information

Reason for update
Two primary outcomes including gene expression of TNF-α and IL-17A were added to the study which will be evaluated using RT-PCR assay.
Acronym
IRCT registration information
IRCT registration number: IRCT2015102824760N1
Registration date: 2016-06-12, 1395/03/23
Registration timing: prospective

Last update: 2023-07-10, 1402/04/19
Update count: 2
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Mojgan Mohammadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
mohammadimzh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellor, Mashhad University of Medical Sciences Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice presidency for Science and Technology
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients
Public title
Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Non-resistant RA patients to non-biological DMARDs
Age
From 35 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qoreishi Bulding, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.MUMS.REC.1402.076

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Interleukin-1
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
pg/ml using ELISA assay

2

Description
TNF-alpha
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
pg/ml using ELISA assay

3

Description
Interleukin-4
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
pg/ml using ELISA assay

4

Description
Interleukin-10
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
pg/ml using ELISA assay

5

Description
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

6

Description
Interleukin-17
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
pg/ml using ELISA assay

7

Description
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

8

Description
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

9

Description
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

10

Description
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

11

Description
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

12

Description
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

13

Description
Th17
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
Frequency of desired cells using flow cytometry technique

14

Description
Disease activity score (DAS)
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
Clinical and laboratory findings

15

Description
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

16

Description
Erythrocyte sedimentation rate(ESR)
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
Erythrocyte sedimentation rate in millimeters

17

Description
C-reactive protein (CRP)
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
Latex agglutination test

18

Description
Rheumatoid factor(RF)
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
Latex agglutination test

19

Description
Anti-cyclic citrullinated peptide (anti-CCP)
Timepoint
Before intervention and after 1, 6, 12 months follow up
Method of measurement
ELISA test

20

Description
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

21

Description
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

Secondary outcomes

1

Description
Anaphylaxis
Timepoint
After IV infusion of MSCs
Method of measurement
Clinical manifestations, hypotension and hypoglycemia

2

Description
Differentiation of MSCs to unwanted cells
Timepoint
After IV infusion of MSCs
Method of measurement
Clinical manifestations

Intervention groups

1

Description
A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(2000000 to 3000000 cells/Kg).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
ِDr. Zhale shariati sarabi
Street address
Ebne Sina Ave, Emam Reza Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3041
Email
ShariatiJ@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Chancellor, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mohammadi
Street address
BuAli research institute, BuAli Sq, Ferdowsi Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2611
Email
Mohammadimzh@mums.ac.ir
Grant name
Grant code / Reference number
931523
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellor, Mashhad University of Medical Sciences
Proportion provided by this source
75
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr
Full name of responsible person
Dr. Amir Ali Hamidieh
Street address
No 21, Ladan Alley, North Sheikh Bahayee St, MollaSadra St, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1415515650
Phone
+98 21 8353 2373
Email
info@stemcell.isti.ir
Grant name
Grant code / Reference number
122
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Council for Stem Cell Sciences and Technologies, Presidency of the Islamic Republic of Iran, Vice pr
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Ghoryani
Position
Ph.D in Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Street address
BuAli Research Institute, BuAli Sq, Ferdowsi Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9188986439
Phone
+98 51 3604 1865
Fax
+98 51 3711 2596
Email
ghoryanim931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mojgan Mohammadi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Street address
BuAli Research Institute, BuAli Square, Ferdowsi Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2611
Fax
+98 51 3711 2596
Email
mohammadimzh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Ghoryani
Position
Ph.D in Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
BuAli research institute, BuAli Sq, Ferdowsi Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9188986439
Phone
+98 51 3604 1865
Fax
+98 51 3711 2596
Email
ghoryanim931@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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