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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 belowSelect...
My lupus is active despite treatment, as shown by specific lupus activity scores.
Select...
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:Select...
I have lupus affecting my kidneys and need dialysis.
Select...
My lupus affects my brain and thinking.
Select...
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
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 moreTrial 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
979 Previous Clinical Trials
7,400,884 Total Patients Enrolled
2 Trials studying Lupus
130 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lupus affecting my kidneys and need dialysis.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.I am between 18 and 65 years old.My lupus affects my brain and thinking.I haven't had shingles or needed hospital care for an infection in the last 3 months.I have taken belimumab within the last 2 months or rituximab within the last 6 months.My lupus is active despite treatment, as shown by specific lupus activity scores.I have completed 6 months of treatment for kidney inflammation.I do not have any health conditions that would stop me from safely completing the study.I haven't taken high doses of prednisone or similar steroids in the last month.I haven't changed my immunosuppressant (except steroids) or used experimental drugs in the last 3 months.I have tested positive for HIV, hepatitis B/C, TB, or have signs of TB/fungal infection on a chest X-ray.I have had a kidney transplant.I need corticosteroids for another health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Mesenchymal Stem Cells (MSCs)
- Group 2: High Dose Mesenchymal Stem Cells (MSCs)
- Group 3: Plasma Lyte A Solution
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.