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NCT03186417 · ClinicalTrials.gov registry record · Phase 1
Mesenchymal Stem Cells in Early Rheumatoid Arthritis
A Phase 1 study, sponsored by MetroHealth Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03186417: Clinical Trial Phase 1 study, sponsored by MetroHealth Medical Center.
NCT03186417 is a Phase 1 study that was terminated before completion, run by MetroHealth Medical Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03186417, a Phase 1 study, was terminated before completion, sponsored by MetroHealth Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
• In addition, a DLT will be assigned if through 14 days after the infusion any grade 3-4 adverse event for pulmonary, cardiac, renal, oral mucosal or hepatic, and grade 4 adverse events for other organs occurred per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL 2 million hMSC/kg
- BIOLOGICAL 4 million hMSC/kg
- BIOLOGICAL 6 million hMSC/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 1 |
Why NCT03186417 stopped before completion
NCT03186417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT03186417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03186417 about?
NCT03186417 is a clinical study titled "Mesenchymal Stem Cells in Early Rheumatoid Arthritis". 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 ...
What is the current status of trial NCT03186417?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-12-15. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT03186417?
The interventions under investigation include: placebo (BIOLOGICAL), 2 million hMSC/kg (BIOLOGICAL), 4 million hMSC/kg (BIOLOGICAL), 6 million hMSC/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03186417?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03186417's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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