Clinical trialNCT02633163CompletedPhase 2Interventional

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

SponsorMedical University of South CarolinaEnrollment81Systemic Lupus Erythematosus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Diane L. Kamen, MD, MSCR
Medical University of South Carolina
Study ChairKOL profile →
clinicaltrials.gov ↗
Gary S. Gilkeson, MD
Medical University of South Carolina
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - San Diego
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
the Feinstein Institute for Medical Research
Manhasset, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

High Dose Mesenchymal Stem CellsLow Dose Mesenchymal Stem CellsPlacebo Infusion

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Nov 2018
Primary completion: 5 Aug 2025
Completion: 3 Feb 2026
Last update posted: 5 Feb 2026
Registered enrollment: 81
Registry id: NCT02633163

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.