- Published in
- Fondation du Rein, ANR eCellFrance
- Authors of report
- Prof Dominique Farge, MD, Lucie Biard, PhDd, Ben Weil, EngDe, Virginie Girault, PhD, Pauline Lansiaux, PhD, Ingrid Munia, MS, Séverine Loisel, PhD, Catney Charles, BSca, Judikael Saout, PhD
- Date of report
- Medical conditions
- Lupus
Summary of the Main Points/Findings
Background and Objective:
This phase 1, dose-escalation trial aimed to assess the safety and preliminary efficacy of allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with severe SLE. The objective was to explore a novel therapeutic approach for patients who had not responded to standard treatments. The Lancet
Methods and Findings:
Participants received a single infusion of UC-MSCs at doses of either 2 × 10⁶ cells per kg or 4 × 10⁶ cells per kg. The primary outcome was safety, while secondary outcomes included changes in disease activity and B-cell profiles. The study found that the treatment was safe and well-tolerated, with no serious adverse events reported. Preliminary efficacy data suggested improvements in disease activity and modulation of B-cell populations.The Lancet
Conclusion:
The infusion of allogeneic UC-MSCs appears to be safe in patients with severe SLE. Placebo-controlled trials are needed to confirm clinical efficacy and further explore the role of B-cell modifications in the therapeutic benefit observed.New England Journal of Medicine+4The Lancet+4The Lancet+4
This is a summary of independent research published elsewhere. It is not a report of Beike treatment outcomes.
