Lupus & antiphospholipid syndrome
Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study
Authors' conclusion
Our results suggest that a single infusion of 2 × 106 cells per kg or 4 × 106 cells per kg of allogeneic umbilical cord-derived mesenchymal stromal cells was safe in patients with severe SLE.
Study context
- Population
- Patients aged 18–70 years with systemic lupus erythematosus (SLE) (ACR criteria, positive ANA), SELENA-SLEDAI score of 6 or more, refractory to first and second line therapies; Saint-Louis University Hospital, Paris, Franceenrolment terminated early
- Participants
- 8 patients
- Outcome
- Rate of treatment-related severe adverse events (grade ≥3)
- Follow-up
- First 10 days after infusion
Methodological detailsprospective, single-centre, open-label, Bayesian, No patients received the 1 × 106 dose
- Prospective
- Single-centre
- Open-label
- Bayesian
- No patients received the 1 × 106 dose
Main finding
As reported in the abstract
Severe adverse events
UC-MSC
0
events
Observational data: associations, not effects.
Safety
| Outcome | Values |
|---|---|
| Infusion-related adverse events (two grade 1, one grade 2), in two patients · first 10 days after infusion | UC-MSC 3 events |
| Treatment-related severe adverse events · 12.4 months (range 12-13) of follow-up | UC-MSC 0 events |
| Non-treatment-related severe adverse events, in one patient after relapse · 12.4 months (range 12-13) of follow-up | UC-MSC 3 events |
Original publication
Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study. Lancet Rheumatol. Published 17 December 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →