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Trial record 3 of 54 for:    stem cell arthritis AND bone marrow

Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT03333681
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE June 20, 2016
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03333681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients
Official Title  ICMJE 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
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.
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 and humoral immune responses and also the role of chemokines in homing of immune cells were studied at time points 1, 6 and 12 months after intravenous administration of MSCs in refractory rheumatoid arthritis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Autologous mesenchymal stem cells
A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(1000000 to 2000000 cells/Kg)
Study Arms  ICMJE Experimental: Refractory rheumatoid arthritis patients
Autologous mesenchymal stem cells
Intervention: Biological: Autologous mesenchymal stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03333681
Other Study ID Numbers  ICMJE 931523
122 ( Other Grant/Funding Number: Council for Stem Cell Sciences and Technologies )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences
Study Sponsor  ICMJE Mashhad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mojgan Mohammadi, Ph.D Mashhad University of Medical Sciences
PRS Account Mashhad University of Medical Sciences
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP