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NCT02633163 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 9
- Study locations
NCT02633163: Completed Phase 2 study of Systemic Lupus Erythematosus, sponsored by Medical University of South Carolina.
NCT02633163 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by Medical University of South Carolina. The registered enrollment target is 81 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633163, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.
Primary Outcome
Systemic Lupus Erythematosus Responder Index (SRI) is defined as a greater than or equal to (≥) 4 point reduction in the Systemic Lupus Erythematosus Disease Activity Index score (SLEDAI), no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B domain score, and no deterioration from Baseline in the Physician's Global Assessment (PGA) by greater than or equal to (≥) 0.3 points. Additionally, to be a "responder", corticosteroid dose must be less than of equal to (≤)10
Conditions Studied
Interventions
- DRUG Low Dose Mesenchymal Stem Cells (MSCs)
- DRUG High Dose Mesenchymal Stem Cells (MSCs)
- DRUG Placebo Infusion
Study Locations (9)
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California - San Diego - San Diego
New York
- The Feinstein Institute for Medical Research - Manhasset
- University of Rochester Medical Center - Rochester
Georgia
- Emory University - Atlanta
Illinois
- Northwestern University - Chicago
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-11-18 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 2 |
What the finished NCT02633163 record still lists
NCT02633163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Low Dose Mesenchymal Stem Cells (MSCs) is the first listed.
NCT02633163 lists 9 locations in 7 states (California, New York, Georgia).
Frequently Asked Questions
What is clinical trial NCT02633163 about?
NCT02633163 is a clinical study titled "Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)". The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care resp...
What is the current status of trial NCT02633163?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2018-11-18. Estimated completion is 2026-02-03.
What conditions does trial NCT02633163 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT02633163?
The interventions under investigation include: Low Dose Mesenchymal Stem Cells (MSCs) (DRUG), High Dose Mesenchymal Stem Cells (MSCs) (DRUG), Placebo Infusion (DRUG).
Who is sponsoring clinical trial NCT02633163?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02633163 being conducted?
This trial has 9 study locations across California, Georgia, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02633163's enrollment target sits among peer trials
81 60th of 99 higher than 40 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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.
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