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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 : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences

Brief Summary:
  1. Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular immune response 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 immune responses.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Autologous mesenchymal stem cells Phase 1

Detailed Description:
Refractory rheumatoid arthritis patients who met the inclusion/exclusion criteria have been selected. After signing informed consent form, autologous stem cells were obtained by bone marrow aspiration. Isolation and culture (3 to 4 weeks in MEM-alpha medium) of mesenchymal stem cells (MSCs) were performed in accredited good manufacturing practices (GMP) clean room. A panel of cluster of differentiation (CD) markers including CD105, CD166, CD44, CD45, CD90, and CD34 were checked for making sure about differentiation of cells into MSCs after 3-4 weeks of cell culture. Viability of MSCs was checked by Trypan blue testing and all of the cultivations were negative for bacterial contamination. A single dose of 1000000 to 2000000 mesenchymal stem cells/kg infused into patients intravenously. To prevent anaphylactic reactions, a single intravenous dose of hydrocortison (100 ml) and oral dimenhydrinate (10 ml) were administered before MSCs infusion into patients. The effects of mesenchymal stem cells on the cellular immune responses were studied at 1, 6 and 12 months after infusion.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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 age 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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: Mojgan Mohammadi, Ph.D Mashhad University of Medical Sciences

Publications:
Responsible Party: Dr. Mojgan Mohammadi, Associate professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03333681     History of Changes
Other Study ID Numbers: 931523
122 ( Other Grant/Funding Number: Council for Stem Cell Sciences and Technologies )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences:
Rheumatoid arthritis
Stem Cells
Cellular immunity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases