Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients
|ClinicalTrials.gov Identifier: NCT03333681|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
- Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular immune response 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 immune responses.
|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 Immune Response in Refractory Rheumatoid Arthritis Patients|
|Actual Study Start Date :||June 20, 2016|
|Estimated Primary Completion Date :||September 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333681
|Principal Investigator:||Mojgan Mohammadi, Ph.D||Mashhad University of Medical Sciences|