Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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.

PubMed Disclaimer

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.

Similar articles

See all similar articles

Cited by

References

    1. Fraenkel L, Bathon JM, England BR, et al. American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021. Jul;73(7):924–939. - PMC - PubMed

    2. • This article provides the 2021 American College of Rheumatology (ACR) guidelines for RA treatment, establishing the standard framework for therapeutic strategies.

    1. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020. Jun;79(6):685–699. - PubMed
    1. Massalska M, Maslinski W, Ciechomska M.. Small molecule inhibitors in the treatment of rheumatoid arthritis and beyond: latest updates and potential strategy for fighting COVID-19. Cells. 2020. Aug 11;9(8). - PMC - PubMed
    1. Angelini J, Talotta R, Roncato R, et al. JAK-inhibitors for the treatment of rheumatoid arthritis: a focus on the present and an outlook on the future. Biomolecules. 2020. Jul 5;10(7). - PMC - PubMed
    1. Nagy G, Roodenrijs NMT, Welsing PMJ, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis. 2021;80(1):31. - PMC - PubMed

    2. •• This article proposes the EULAR definition of “difficult-to-treat rheumatoid arthritis,” aiding in patient classification and trial consistency.

Publication types