Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients
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
2 other identifiers
interventional
15
0 countries
N/A
Brief Summary
- 1.Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular and humoral immune responses in refractory rheumatoid arthritis (RA) patients.
- 2.Design: This study has been performed as a phase 1 clinical trial.
- 3.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.
- 4.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.
- 5.Intervention: A single dose of intravenous autologous bone marrow derived mesenchymal stem cells have been administered into patients with resistance to non-biological DMARDs.
- 6.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 rheumatoid-arthritis
Started Jun 2016
Typical duration for phase_1 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2016
CompletedFirst Submitted
Initial submission to the registry
September 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedMarch 13, 2019
March 1, 2019
2.2 years
September 14, 2017
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of mesenchymal stem cells therapy on the percentage of regulatory T cells
Percentage change in regulatory T cells from baseline which is analysed by fluorescence-activated cell sorting (FACS)
At 0 and 6 months follow up
Study Arms (1)
Refractory rheumatoid arthritis patients
EXPERIMENTALAutologous mesenchymal stem cells
Interventions
A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(1000000 to 2000000 cells/Kg)
Eligibility Criteria
You may qualify if:
- Resistant RA patients to non-biological DMARDs;
- Treated RA patients by non-biological drugs;
- Treated RA patients by Prednisolone, Hydroxychloroquine, Sulfasalazine and Methotrexate;
- Patients age between 35-60 years;
- Refractory RA patients with no other rheumatologic disorders and inflammatory diseases.
You may not qualify if:
- Non-resistant RA patients to non-biological DMARDs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Alvaro-Gracia JM, Jover JA, Garcia-Vicuna R, Carreno L, Alonso A, Marsal S, Blanco F, Martinez-Taboada VM, Taylor P, Martin-Martin C, DelaRosa O, Tagarro I, Diaz-Gonzalez F. Intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis (Cx611): results of a multicentre, dose escalation, randomised, single-blind, placebo-controlled phase Ib/IIa clinical trial. Ann Rheum Dis. 2017 Jan;76(1):196-202. doi: 10.1136/annrheumdis-2015-208918. Epub 2016 Jun 7.
PMID: 27269294BACKGROUNDLiang J, Li X, Zhang H, Wang D, Feng X, Wang H, Hua B, Liu B, Sun L. Allogeneic mesenchymal stem cells transplantation in patients with refractory RA. Clin Rheumatol. 2012 Jan;31(1):157-61. doi: 10.1007/s10067-011-1816-0. Epub 2011 Aug 12.
PMID: 21837432BACKGROUNDWang L, Wang L, Cong X, Liu G, Zhou J, Bai B, Li Y, Bai W, Li M, Ji H, Zhu D, Wu M, Liu Y. Human umbilical cord mesenchymal stem cell therapy for patients with active rheumatoid arthritis: safety and efficacy. Stem Cells Dev. 2013 Dec 15;22(24):3192-202. doi: 10.1089/scd.2013.0023. Epub 2013 Oct 4.
PMID: 23941289BACKGROUNDRahimi Khorashad M, Ghoryani M, Gowhari Shabgah A, Shariati-Sarabi Z, Tavakkol Afshari J, Mohammadi M. The Effects of Mesenchymal Stem Cells on the Gene Expression of TGF-beta and IFN-gamma in Patients with Rheumatoid Arthritis. Iran J Allergy Asthma Immunol. 2023 Apr 30;22(2):183-189. doi: 10.18502/ijaai.v22i2.12679.
PMID: 37496411DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mojgan Mohammadi, Ph.D
Mashhad University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 14, 2017
First Posted
November 7, 2017
Study Start
June 20, 2016
Primary Completion
August 15, 2018
Study Completion
September 15, 2018
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share