Mesenchymal Stem Cells for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether umbilical cord-derived mesenchymal stem cells (MSCs) can safely and effectively treat adults with systemic lupus erythematosus (SLE), a disease where the immune system attacks the body's own tissues. Participants will receive either a high or low dose of MSCs or a placebo, alongside their usual care, to determine if the stem cells improve their condition. Suitable candidates have active lupus symptoms and continue to struggle with the disease despite standard treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you must stop all current medications. However, you cannot change or add to your immunosuppressant regimen within 3 months of the Baseline visit, and you must not have used prednisone >0.5 mg/kg/day within 1 month of the Baseline visit. Also, you should not have received certain biologic therapies like belimumab within 2 months or rituximab within 6 months of the Baseline visit.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop all current medications, but it does mention that you should not have changes or additions to your immunosuppressant regimen within 3 months of the start, except for corticosteroids. Also, you should not have used certain medications like belimumab or rituximab within specific time frames before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stem cells from umbilical cords are generally safe for treating conditions like systemic lupus erythematosus (SLE). Studies have found that both high and low doses of these stem cells are usually well-tolerated by patients. In one study, participants who received these stem cells reported few side effects, indicating the treatment is relatively safe.
These positive safety results come from several studies on stem cell therapy for SLE. These studies have found minimal side effects, making the treatment promising for those considering joining a trial. While outcomes cannot be guaranteed, past evidence suggests that these stem cells are a safe option for many patients with SLE.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for lupus, which often include immunosuppressive drugs like corticosteroids and antimalarials, Mesenchymal Stem Cells (MSCs) offer a novel approach by potentially modulating the immune system naturally. High-dose MSCs involve administering 5 million cells per kilogram, while the low-dose version uses 1 million cells per kilogram, both in a Plasma-Lyte A solution. Researchers are particularly excited because MSCs might help repair damaged tissues and reduce inflammation without the side effects common to traditional drugs. This could represent a major shift in lupus treatment, providing a more targeted and less toxic option.
What evidence suggests that mesenchymal stem cells might be an effective treatment for lupus?
Research has shown that stem cells from umbilical cords might help treat systemic lupus erythematosus (SLE). In this trial, participants will receive either a high dose or a low dose of these stem cells, or a placebo infusion. Studies have found that a high dose of these stem cells can lead to remission, reducing disease activity and improving lupus symptoms by modulating the immune system. This includes calming harmful immune responses and enhancing organ function. Even low doses of stem cells have demonstrated benefits, helping to control the disease and reduce symptoms. Both high and low doses can prevent the body from mistakenly attacking itself, a hallmark of autoimmune diseases like SLE. Overall, stem cell therapy is emerging as a promising option for SLE patients, especially for those unresponsive to other treatments.12367
Who Is on the Research Team?
Gary S. Gilkeson, MD
Principal Investigator
Medical University of South Carolina
Diane L. Kamen, MD, MSCR
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a low or high dose of mesenchymal stem cells or placebo through a single IV infusion, along with standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at Weeks 12, 24, and 52
What Are the Treatments Tested in This Trial?
Interventions
- High Dose Mesenchymal Stem Cells (MSCs)
- Low Dose Mesenchymal Stem Cells (MSCs)
- Placebo Infusion
High Dose Mesenchymal Stem Cells (MSCs) is already approved in China, United States for the following indications:
- Systemic Lupus Erythematosus (SLE)
- Lupus Nephritis
- Refractory Systemic Lupus Erythematosus (SLE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor