← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 12, 24, and 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My lupus is active despite treatment, as shown by specific lupus activity scores.
Select...
I have completed 6 months of treatment for kidney inflammation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical response at Week 24 as defined by the SLE Responder Index (SRI)
Secondary outcome measures
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
936 Previous Clinical Trials
7,396,757 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can enroll in this clinical trial?

"That is correct, the information available on clinicaltrials.gov does suggest that this study is looking for more patients as of 9/6/2022. The original posting date was 10/26/2018 and 81 people are needed from 8 different locations."

Answered by AI

Could you tell me how many hospitals have been selected to participate in this trial?

"In total, 11 sites are participating in this study. They are: University of North carolina at Chapel Hill (Chapel Hill, North Carolina), Northwestern University (Chicago, Illinois), and University of Rochester Medical Center (Rochester, New york) along with 8 other locations."

Answered by AI

What are some conditions that Low Dose Mesenchymal Stem Cells (MSCs) can help treat?

"Low Dose Mesenchymal Stem Cells (MSCs) are a promising treatment for diarrhea, as well as other medical interventions such as general surgery and urine alkalinization therapy."

Answered by AI

Are there specific inclusionary criteria for this research?

"Eligible patients must be aged 18-65, have a systemic lupus erythematosus diagnosis, and fit the following criteria: a historical presence of at least 4 out of 11 ACR Classification Criteria, an active SLE as determined by a SLEDAI score ≥6, and the presence of at least one BILAG A or BILAG B despite standard care. If the patient has a renal organ system BILAG A or BILAG B score, he/she must have completed 6 months of therapy for the current nephritis episode prior to screening. The required therapy must include mycop"

Answered by AI

Are Low Dose Mesenchymal Stem Cells (MSCs) accepted by the FDA?

"Given that this is a Phase 2 trial (i.e. there is safety data but no efficacy data), Power has given Low Dose Mesenchymal Stem Cells (MSCs) a score of 2 for safety."

Answered by AI

Are people still being given the opportunity to enroll in this clinical trial?

"The most recent information on clinicaltrials.gov confirms that this study is looking for patients right now. The trial was first posted on October 26th, 2018 and the listing was last updated on September 6th, 2020."

Answered by AI

Are Low Dose Mesenchymal Stem Cells (MSCs) a new topic of research?

"112 clinical trials are currently underway to study the effects of Low Dose Mesenchymal Stem Cells (MSCs), 30 of which are in Phase 3. Clinical trials for Low Dose Mesenchymal Stem Cells (MSCs) are being conducted at 390 locations, several of which are based in Philadelphia, Pennsylvania."

Answered by AI

Does this study have an age limit, and if so, what is it?

"For this particular clinical trial, only patients that are aged 18-65 can enroll. Out of the 230 total trials, 34 were for treatments targeting individuals under 18 and 196 were for those over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Oklahoma Medical Research Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Trying to figure out what’s wrong with my and go thru some trials.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)
2018. "Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02633163.
All > Systemic Lupus Erythematosus > Lupus
~7 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top