UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients (NCT06737380)
A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived - Mesenchymal Stromal Cell Therapy in Addition to Standard of Care as A Treatment For Active Systemic Lupus Erythematosus
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE). The main questions this study aims to answer are: 1. Can UC-MSCs improve kidney function and reduce SLE disease activity? 2. Are UC-MSCs safe and well-tolerated in this patient population? Participants in this study will: * Receive UC-MSCs in a single dose in addition to standard of care treatment. * Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies). * Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health. * Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values. This study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.
Who can join: Review the eligibility criteria below.
Location: Medical University of South Carolina โ Charleston, South Carolina
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Medical University of South Carolina โ Charleston, South Carolina
๐ Contact the Study Coordinator
Phone: +972524753435
Email: nadyal@galilee-cbr.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in SLE
- Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus โ Anniston, Alabama
- Myocardial Inflammation in Systemic Lupus Erythematosus โ Columbus, Ohio
- CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus โ Philadelphia, Pennsylvania
- A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus โ Avondale, Arizona
Explore by condition: All SLE clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.