Using stem cells to treat severe lupus
Official title: A Phase II Controlled Trial of Allogeneic Mesenchymal Stromal Cells for the Treatment of Refractory Lupus (MiSLE)
Funded at Medical University of South Carolina · NIH-11159694 · Data updated 2026-11-12
This study is looking at whether a special type of cell treatment can help people with stubborn lupus feel better and stay safe, and it’s designed so that neither you nor the researchers will know who gets the real treatment or a placebo to keep things fair.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Medical University of South Carolina NIH-funded |
| Lab location | 1 site (Charleston, United States) |
| Project start | August 1, 2024 |
| Project end | May 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $1,459,720 |
| NIH project number | 5U01AI184159-02 |
| Project ID | NIH-11159694 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals diagnosed with refractory lupus who have not responded adequately to standard treatments.
✕Less likely to help
Patients with mild lupus or those who have not yet tried standard therapies may not benefit from this research.
What this research studies
This research investigates the use of mesenchymal stromal cells (MSCs) as a treatment for patients with refractory lupus, a challenging autoimmune condition. The trial is a multi-center, double-blind, placebo-controlled study, meaning that neither the patients nor the researchers know who receives the treatment or the placebo, which helps ensure unbiased results. The study aims to determine the effectiveness and safety of MSCs based on previous promising results from earlier trials. Patients will be monitored for their response to treatment and any potential side effects throughout the trial period.
Why it matters
Potential benefit: If successful, this research could provide a new, effective treatment option for patients suffering from refractory lupus.
How similar studies have gone: Previous trials using MSCs for autoimmune diseases have shown promising results, indicating potential for success in this approach.
Where this research is happening
-
Medical University of South Carolina
Charleston, United States Active
Researchers
- Principal investigator: Gilkeson, Gary S — Medical University of South Carolina
- Study coordinator: Gilkeson, Gary S
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.