Condition: Systemic lupus erythematosus
Key Inclusion Criteria
- 18-65 years old
- Historical presence of at least 4 of 11 of the American College of Rheumatology classification criteria for systemic lupus erythematosus
- Clinically active SLE
Key Exclusion Criteria
- Active central nervous system lupus affecting mental status
- Active lupus nephritis requiring dialysis
- Evidence of infection with human immunodeficiency virus, hepatitis B or hepatitis C
- Having received belimumab within 2 months, or rituximab or other biologics within 6 months
Full Study Name
A Phase II Study Evaluating the Safety and Feasibility of Allogeneic Umbilical Cord Derived Mesenchymal Stromal cells (MSC) for the Treatment of Adults With Treatment Refractory Lupus (IRB no. 39875)
This study focuses on individuals who have moderate to severely active systemic lupus erythematosus (SLE). The purpose of the study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with active SLE. Treatments for SLE remain inadequate with significant side effects, especially for women of childbearing potential; there is a significant need for safer and more effective therapies.
The MSCs used in this study are cells that are obtained from the umbilical cords of healthy donors having an elective Caesarean section and who have been screened to be free of infectious diseases. The investigational cells will be collected and processed so that they can be used as an infusion treatment. Participants will be randomly assigned (in a 2:1 ratio) to receive either MSCs or placebo (inactive substance) infusions. Researchers aim to determine whether patients receiving an MSC infusion in addition to standard of care for SLE respond better than those receiving placebo infusion.