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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 is a Phase 1 study that was terminated before completion, run by MetroHealth Medical Center. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03186417
The ClinicalTrials.gov registry entry for NCT03186417 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT03186417 reports 0 study locations.
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.
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