NCT03186417

Mesenchymal Stem Cells in Early Rheumatoid Arthritis

Terminated Phase 1 Last updated 23 June 2023

What this trial tests

Phase 1 trial testing 2 million hMSC/kg in Rheumatoid Arthritis in 10 participants. Terminated before completion.

Timeline

15 December 2017

Primary endpoint
30 April 2023

31 May 2023

Quick facts

Lead sponsor	MetroHealth Medical Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	10
Start date	15 December 2017
Primary completion	30 April 2023
Estimated completion	31 May 2023
Sites	2 locations across United States

Drugs / interventions tested

• 2 million hMSC/kg — full drug profile →
• 4 million hMSC/kg — full drug profile →
• 6 million hMSC/kg — full drug profile →
• placebo

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

MetroHealth Medical Center

Who can join

Adults 18 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, multicenter, double-blind, placebo controlled interventional study to evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSCs) in 20 patients with new onset Rheumatoid Arthritis (RA). The study is a single dose, phase I clinical trial and is the first time that this product will be infused in RA patients. The study duration is approximately fourteen months from time of screening to completion.

Research hypothesis: The investigators hypothesize that when administered therapeutically, MSCs will induce healthy immune responses and will reduce RA disease activity. This study is primarily focused on demonstrating the safety of this approach.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
2. Mesenchymal Stem/Stromal Cells for Rheumatoid Arthritis Treatment: An Update on Clinical Applications.
   Lopez-Santalla M, Fernandez-Perez R, Garin MI. · · 2020 · cited 98× · PMID 32784608 · DOI 10.3390/cells9081852
3. Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges.
   Shan Y, Zhang M, Tao E, Wang J, et al · · 2024 · cited 47× · PMID 39271680 · DOI 10.1038/s41392-024-01936-8
4. Rheumatoid arthritis: the old issue, the new therapeutic approach.
   Babaahmadi M, Tayebi B, Gholipour NM, Kamardi MT, et al · · 2023 · cited 42× · PMID 37741991 · DOI 10.1186/s13287-023-03473-7
5. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
6. Multipotent Mesenchymal Stromal Cells in Rheumatoid Arthritis and Systemic Lupus Erythematosus; From a Leading Role in Pathogenesis to Potential Therapeutic Saviors?
   El-Jawhari JJ, El-Sherbiny Y, McGonagle D, Jones E. · · 2021 · cited 30× · PMID 33732263 · DOI 10.3389/fimmu.2021.643170
7. Cell-based therapies for rheumatoid arthritis: opportunities and challenges.
   Li YJ, Chen Z. · · 2022 · cited 26× · PMID 35634355 · DOI 10.1177/1759720x221100294
8. Current advancements in cellular immunotherapy for autoimmune disease.
   Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5