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Mesenchymal Stem Cells

Mesenchymal Stem Cells for Lupus

Phase 2
Recruiting
Led By Gary S. Gilkeson, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically active SLE determined by SLEDAI score ≥6 and the presence of at least one BILAG A or BILAG B at screening, despite standard-of-care therapy
If the patient has a BILAG A or BILAG B score in the renal organ system, he/she must have completed at least 6 months of therapy for the current episode of nephritis prior to Screening. Therapy must include at least 6 months of mycophenolate or at least 3 months of cyclophosphamide followed by mycophenolate or azathioprine
Must not have
Active lupus nephritis requiring dialysis
Active CNS lupus affecting mental status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 12, 24, and 52

Summary

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

Who is the study for?
Adults aged 18-65 with active Systemic Lupus Erythematosus (SLE), evidenced by specific antibody tests and a minimum SLEDAI score, can join. They must have been on standard therapy for lupus nephritis if present. Exclusions include severe kidney issues, certain infections like HIV or TB, recent cancer (except some skin cancers/cervical carcinoma in situ), pregnancy/breastfeeding without contraception use, major organ transplants, unstable medical conditions, high steroid use recently or changes in immunosuppressants.
What is being tested?
The trial is testing the effectiveness of two different doses of Mesenchymal Stem Cells from umbilical cords against a placebo. All participants will continue their standard lupus treatments. The main goal is to see if those who get the stem cells show more improvement than those who get the placebo.
What are the potential side effects?
Potential side effects are not specified but may include typical risks associated with infusions such as infection risk at injection site, allergic reactions to infusion components, and possible immune system responses due to introduction of foreign cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lupus is active despite treatment, as shown by specific lupus activity scores.
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I have completed 6 months of treatment for kidney inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lupus affecting my kidneys and need dialysis.
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My lupus affects my brain and thinking.
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I haven't had shingles or needed hospital care for an infection in the last 3 months.
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I have tested positive for HIV, hepatitis B/C, TB, or have signs of TB/fungal infection on a chest X-ray.
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I have had a kidney transplant.
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I need corticosteroids for another health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 12, 24, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 12, 24, and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical response at Week 24 as defined by the SLE Responder Index (SRI)
Secondary study objectives
Change in SLEDAI score between groups
Changes in Depression
Changes in Fatigue
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Mesenchymal Stem Cells (MSCs)Experimental Treatment1 Intervention
Mesenchymal Stem Cells (MSCs) 1 x 10\^6 cells/kg in Plasma-Lyte A solution
Group II: High Dose Mesenchymal Stem Cells (MSCs)Experimental Treatment1 Intervention
Mesenchymal Stem Cells MSCs 5 x 10\^6 cells/kg in Plasma-Lyte A solution
Group III: Plasma Lyte A SolutionPlacebo Group1 Intervention
Placebo Infusion (Plasma-Lyte A solution only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose Mesenchymal Stem Cells (MSCs)
2017
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,303 Total Patients Enrolled
1 Trials studying Lupus
120 Patients Enrolled for Lupus
Gary S. Gilkeson, MDPrincipal InvestigatorMedical University of South Carolina
Diane L. Kamen, MD, MSCRStudy ChairMedical University of South Carolina
2 Previous Clinical Trials
756 Total Patients Enrolled

Media Library

High Dose Mesenchymal Stem Cells (MSCs) (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT02633163 — Phase 2
Lupus Research Study Groups: Low Dose Mesenchymal Stem Cells (MSCs), High Dose Mesenchymal Stem Cells (MSCs), Plasma Lyte A Solution
Lupus Clinical Trial 2023: High Dose Mesenchymal Stem Cells (MSCs) Highlights & Side Effects. Trial Name: NCT02633163 — Phase 2
High Dose Mesenchymal Stem Cells (MSCs) (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02633163 — Phase 2
~0 spots leftby Dec 2024
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