NCT01851070

A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor

Completed Phase 2 Last updated 25 June 2020

What this trial tests

Phase 2 trial testing Allogeneic Mesenchymal Precursor Cells in Rheumatoid Arthritis in 48 participants. Completed in 1 March 2017.

Timeline

1 July 2013

Primary endpoint
1 May 2016

1 March 2017

Quick facts

Lead sponsor	Mesoblast, Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	48
Start date	1 July 2013
Primary completion	1 May 2016
Estimated completion	1 March 2017
Sites	23 locations across United States, Australia

Drugs / interventions tested

• Allogeneic Mesenchymal Precursor Cells — full drug profile →
• Normal Saline

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Mesoblast, Ltd. — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
  Time frame: 12 weeks post IV Infusion
  To evaluate the safety, tolerability and feasibility of a single intravenous (IV) infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other oral DMARDs for at least 4 months and who have had an incomplete response to at least one course of a TNFα

Sponsor's own description

Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.

Publications & conference data

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

1. 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
2. Cell-based therapies for rheumatoid arthritis: opportunities and challenges.
   Li YJ, Chen Z. · · 2022 · cited 26× · PMID 35634355 · DOI 10.1177/1759720x221100294
3. Emerging immunotherapies for rheumatoid arthritis.
   Reynolds G, Cooles FA, Isaacs JD, Hilkens CM. · · 2014 · cited 16× · PMID 24535556 · DOI 10.4161/hv.27910
4. Reestablish immune tolerance in rheumatoid arthritis.
   Shuai Z, Zheng S, Wang K, Wang J, et al · · 2022 · cited 15× · PMID 36248797 · DOI 10.3389/fimmu.2022.1012868
5. Management of Rheumatoid Arthritis: Possibilities and Challenges of Mesenchymal Stromal/Stem Cell-Based Therapies.
   Shimizu Y, Ntege EH, Azuma C, Uehara F, et al · · 2023 · cited 14× · PMID 37508569 · DOI 10.3390/cells12141905
6. Cell-Based Therapy and Genome Editing as Emerging Therapeutic Approaches to Treat Rheumatoid Arthritis.
   Chasov V, Ganeeva I, Zmievskaya E, Davletshin D, et al · · 2024 · cited 8× · PMID 39120313 · DOI 10.3390/cells13151282
7. Futuristic Novel Therapeutic Approaches in the Treatment of Rheumatoid Arthritis.
   Rai V, Patel N, Mammen SR, Chaudhary SM, et al · · 2023 · cited 7× · PMID 38161868 · DOI 10.7759/cureus.49738
8. Mesenchymal Stromal Cells: Updates and Therapeutic Outlook in Rheumatic Diseases.
   Pers YM, Jorgensen C. · · 2013 · cited 5× · PMID 26237144 · DOI 10.3390/jcm2040201