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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015102824760N1

Enrollment

Registered

2016-06-12

Start date

2016-06-19

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis. Diseases of the musculoskeletal system and connective tissue

Interventions

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

Eligibility

Sex/Gender

All

Age

35 Years to 60 Years

Inclusion 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

Exclusion criteria: Non-resistant RA patients to non-biological DMARDs

Design outcomes

Primary

Measure	Time frame
Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: ELISA test.;TNF-a. 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.;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 inter	—

Measure

Time frame

Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 1, 6, 12 months follow up. Method of measurement: ELISA test.;TNF-a. 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.;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 inter

—

Secondary

Measure	Time frame
Differentiation of MSCs to unwanted cells. Timepoint: After IV infusion of MSCs. Method of measurement: Clinical manifestations.;Anaphylaxis. Timepoint: After IV infusion of MSCs. Method of measurement: Clinical manifestations, hypotension and hypoglycemia.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Ghoryani

Mashhad University of Medical Sciences

ghoryanim931@mums.ac.ir+98 51 3604 1865

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026