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Allogeneic Bone Marrow Derived Clonal Mesenchymal Stromal Cells in Refractory Rheumatoid Arthritis: A Pilot Study Publisher Pubmed



Jamshidi A1 ; Beheshti Maal A2 ; Alikhani M1 ; Madani H2 ; Sadri B2 ; Moghaddassi M3 ; Salimzadeh A3 ; Ahmadipour M2 ; Shahrbaf MA2 ; Hajizadehsaffar E2, 4 ; Baghaban Eslaminejad M5 ; Hassani SN4, 5 ; Taghiyar L4, 5 ; Abbasi F4, 5 Show All Authors
Authors
  1. Jamshidi A1
  2. Beheshti Maal A2
  3. Alikhani M1
  4. Madani H2
  5. Sadri B2
  6. Moghaddassi M3
  7. Salimzadeh A3
  8. Ahmadipour M2
  9. Shahrbaf MA2
  10. Hajizadehsaffar E2, 4
  11. Baghaban Eslaminejad M5
  12. Hassani SN4, 5
  13. Taghiyar L4, 5
  14. Abbasi F4, 5
  15. Baharvand H5, 6
  16. Vosough M2
Show Affiliations
Authors Affiliations
  1. 1. Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
  3. 3. Rheumatology Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Advanced Therapy Medicinal Product Technology Development Center (ATMP-TDC), Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
  5. 5. Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
  6. 6. Department of Developmental Biology, School of Basic Sciences and Advanced Technologies in Biology, University of Science and Culture, Tehran, Iran

Source: Regenerative Medicine Published:2024


Abstract

Aims: This phase I trial assessed the safety and potential efficacy of monthly 3 dose intravenous infusion of allogeneic bone marrow-derived clonal mesenchymal stromal cells (BM-cMSCs) in refractory rheumatoid arthritis (RA) patients over 24 weeks. Patients & Methods: Six patients with refractory RA received BM-cMSC infusions at one-month intervals over a 24-week period. Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Clinical efficacy was assessed using the Visual Analog Scale (VAS), Simple and Clinical Disease Activity Indices (SDAI/CDAI), Health Assessment Questionnaire (HAQ), and American College of Rheumatology (ACR) response criteria. Serological makers including: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), IL-10, IL-17, TNF-α, and Treg/Th17 ratios were measured. Results: BM-cMSC infusions were well-tolerated, with no SAEs reported. VAS scores improved in three patients, with two achieving sustained pain relief and quality-of-life enhancement. Four patients met ACR20 at week 16, while SDAI and CDAI scores indicated disease activity reduction in three patients. Anti-CCP and RF levels showed variable responses, with some increases not consistently correlating with clinical outcomes. Serological biomarkers showed mixed results; IL-10 increased in five patients, while pro-inflammatory markers TNF-α and IL-17 decreased in the same individuals. Conclusions: BM-cMSC therapy demonstrated a favorable safety profile and potential efficacy in managing refractory RA. While preliminary results are promising, further studies with larger cohorts and long-term follow-up are needed to validate these findings and optimize therapeutic strategies. Clinical Trial registration: IRCT20080728001031N29. © 2024 Informa UK Limited, trading as Taylor & Francis Group.