Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients
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|ClinicalTrials.gov Identifier: NCT03333681|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : October 30, 2018
- Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular and humoral immune responses in refractory rheumatoid arthritis (RA) patients.
- Design: This study has been performed as a phase 1 clinical trial.
- Setting and conduct: Autologous bone marrow derived mesenchymal stem cells were obtained by bone marrow aspiration and cultured in Minimum Essential Medium-Alpha (MEM-alpha) for 4 weeks in standard clean room and then transfused to RA patients intravenously.
- Participant's major eligibility criteria is as follows: Ten refractory rheumatoid arthritis patients who show resistance to non biological Disease-modifying antirheumatic drugs (DMARDs) after 6 to 12 months have been enrolled in this study.
- Intervention: A single dose of intravenous autologous bone marrow derived mesenchymal stem cells have been administered into patients with resistance to non-biological DMARDs.
- Main outcome measures (variables): Finding of mesenchymal stem cell therapy effects on the cellular and humoral immune responses and evaluation of the effect of chemokines in homing of immune cells following the intervention.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Autologous mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Mesenchymal Stem Cell Therapy Effects on the Cellular and Humoral Immune Responses and Additionally Study on the Effect of Chemokines in Homing of the Immune Cells in Refractory Rheumatoid Arthritis Patients|
|Actual Study Start Date :||June 20, 2016|
|Estimated Primary Completion Date :||November 20, 2018|
|Estimated Study Completion Date :||December 20, 2018|
Experimental: Refractory rheumatoid arthritis patients
Autologous mesenchymal stem cells
Biological: Autologous mesenchymal stem cells
A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(1000000 to 2000000 cells/Kg)
- Effect of mesenchymal stem cells therapy on the percentage of regulatory T cells [ Time Frame: At 0 and 6 months follow up ]Percentage change in regulatory T cells from baseline which is analysed by fluorescence-activated cell sorting (FACS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333681
|Principal Investigator:||Mojgan Mohammadi, Ph.D||Mashhad University of Medical Sciences|