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Clinical Trial
. 2024 Dec;19(12):599-609.
doi: 10.1080/17460751.2024.2443352. Epub 2024 Dec 23.

Allogeneic bone marrow derived clonal mesenchymal stromal cells in refractory rheumatoid arthritis: a pilot study

Ahmadreza Jamshidi  1 , Alireza Beheshti Maal  2 , Majid Alikhani  1 , Hoda Madani  2 , Bahareh Sadri  2 , Maryam Moghaddassi  3 , Ahmad Salimzadeh  3 , Mahtab Ahmadipour  2 , Mohammad Amin Shahrbaf  2 , Ensiyeh Hajizadeh-Saffar  2   4 , Mohamadreza Baghaban Eslaminejad  5 , Seyedeh-Nafiseh Hassani  4   5 , Leila Taghiyar  4   5 , Fatemeh Abbasi  4   5 , Hossein Baharvand  5   6 , Massoud Vosough  2
Affiliations
Clinical Trial

Allogeneic bone marrow derived clonal mesenchymal stromal cells in refractory rheumatoid arthritis: a pilot study

Ahmadreza Jamshidi et al. Regen Med. 2024 Dec.

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.

Keywords: Cell therpay; Rheumatoid arthritis; clinical trial; mesenchymal stromal cells; regenerative medicine.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1.
Figure 1.
The schematic overview of the study design.
Figure 2.
Figure 2.
Patients flow diagram of the study.
Figure 3.
Figure 3.
(a) VAS and (b) HAQ score of the patents during the course of study. (c) ESR and (d) CRP levels of the patients during the course of the study. VAS: visual analogue scale; HAQ: health assessment questionnaire; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein.
Figure 4.
Figure 4.
Number of patients achieving ACR20 responses. ACR: American college of rheumatology.
See this image and copyright information in PMC

References

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