MSC-SLE Lupus

Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord (EUDRACT N° 2017 001400 29)

Project phases

Preclinical

GMP Manufacturing

Phase I Clinical trial

Phase II Clinical trial

Completed

Single center phase I-II study NCT03562065

Pr Dominique Farge, Internal Medicine, Autoimmune Diseases and Vascular Pathology, Hôpital Saint-Louis, Paris, France.

To assess the tolerance of allogeneic umbilical cord derived MSC administration for severe SLE refractory to standard therapies (cyclophosphamide mycophenolate mofetil and corticosteroids with or without anti CD20)

Primary endpoint: Immediate tolerance as assessed during the first injection and 10 days after the allogeneic MSC injection, according to standards CTCAE side effects.

Single center phase I-II study NCT03562065

Allogeneic Umbilical Cord derived-MSCs are injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of:

1.106 MSC / kg
2.106 MSC / kg
4.106 MSC / kg

Number of patients planned in the study: 10 patients.

To date, 8 patients have benefited from this treatment.