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COMPLETED Phase 2

Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

NCT02633163 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 81 participants
Start Date 2018-11-18
Est. Completion 2026-02-03
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02633163

The ClinicalTrials.gov registry entry for NCT02633163 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02633163 reports 9 study locations spanning 7 distinct geographic areas — top geographies include California, New York, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02633163?

This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial