drugset / Trial / NCT03186417

Mesenchymal Stem Cells in Early Rheumatoid Arthritis

NCT03186417 ↗

RandomizedSequentialQuadruple-blindTreatment

Summary

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.

Timeline

Start
2017-12-15
Primary completion
2023-04-30
Completion
2023-05-31

Outcome

Outcome not reported

Stopped (Enrollment): “slow enrollment during covid and lack of funds to continue”

Drugs

EvaluationDrugModalityDoseRoute
Subject hMSC Cell therapy 2e+06 cells/kg —
Subject hMSC Cell therapy 4e+06 cells/kg —
Subject hMSC Cell therapy 6e+06 cells/kg —

Indications