Low Dose Mesenchymal Stem Cells (MSCs) for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lupus Erythematosus, Systemic+1 More
Low Dose Mesenchymal Stem Cells (MSCs) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if stem cells from umbilical cords can help treat adults with Lupus.

Eligible Conditions
  • Lupus Erythematosus, Systemic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lupus Erythematosus, Systemic

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline to Weeks 12, 24, and 52

Week 12
Kidney
Baseline to Week 52
Changes in Depression
Changes in Fatigue
Changes in HR-QOL
Changes in Pain
Changes in SLICC-DI
Changes in patient-reported lupus-specific disease status
Changes in the presence of serum and urine biomarkers of SLE activity
Steroid-sparing effect
Week 12
Change in SLEDAI score between groups
Week 24
Clinical response at Week 24 as defined by the SLE Responder Index (SRI)
Week 52
Cumulative systemic steroid dose

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lupus Erythematosus, Systemic

Trial Design

3 Treatment Groups

Low Dose Mesenchymal Stem Cells (MSCs)
1 of 3
High Dose Mesenchymal Stem Cells (MSCs)
1 of 3
Plasma Lyte A Solution
1 of 3
Experimental Treatment
Non-Treatment Group

81 Total Participants · 3 Treatment Groups

Primary Treatment: Low Dose Mesenchymal Stem Cells (MSCs) · Has Placebo Group · Phase 2

Low Dose Mesenchymal Stem Cells (MSCs)
Drug
Experimental Group · 1 Intervention: Low Dose Mesenchymal Stem Cells (MSCs) · Intervention Types: Drug
High Dose Mesenchymal Stem Cells (MSCs)
Drug
Experimental Group · 1 Intervention: High Dose Mesenchymal Stem Cells (MSCs) · Intervention Types: Drug
Plasma Lyte A Solution
Drug
PlaceboComparator Group · 1 Intervention: Placebo Infusion · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose Mesenchymal Stem Cells (MSCs)
2017
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to weeks 12, 24, and 52

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
833 Previous Clinical Trials
5,373,143 Total Patients Enrolled
9 Trials studying Lupus Erythematosus, Systemic
1,366 Patients Enrolled for Lupus Erythematosus, Systemic
Diane L. Kamen, MD, MSCRStudy ChairMedical University of South Carolina
2 Previous Clinical Trials
756 Total Patients Enrolled
2 Trials studying Lupus Erythematosus, Systemic
756 Patients Enrolled for Lupus Erythematosus, Systemic
Gary S. Gilkeson, MDPrincipal InvestigatorMedical University of South Carolina

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of rheumatoid arthritis that has been present for at least 4 years.
You have evidence of a positive ANA or positive dsDNA antibody test within 6 months of screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.