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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 12, 24, and 52

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

968 Previous Clinical Trials

7,399,657 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

~1 spots leftby Dec 2024

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