Research Project

Project Title:	Reduce Immunosuppression With Atmp in NS ChildrEn (RACE)
Project Type:	Clinical Trial, Enrolment ongoing
Disease group(s):	Immune glomerulopathies
Project Summary:	A phase II open-label, single arm study aimed to ascertain whether infusions of cord-blood mesenchymal stromal cells (CB-MSCs) allow to reduce or suspend the chronic immunosuppressive therapy (IS) in steroid-dependent nephrotic syndrome (SDNS). We plan to enroll 11 patients aged 3 to 18 with SDNS in remission for at least one month, maintained by either ≥2 immunosuppressive drugs or a calcineurin inhibitor. Patients are infused with cord-blood allogenic MSC, selected by in-vitro alloreactivity, at a dose of 1.5x10^6/kg on days 0, 14, 21. The immunosuppressive treatment is gradually tapered starting at the first CB-MSC administration, according to the following scheme: 25% following the first administration, 50% following the second administration, and 100% reduction following the third administration.
Lead principal investigator(s):	Giovanni Montini, Milan
Project Period:	11/2018 - 12/2021
Sponsors:	Non-profit foundation
ClinicalTrials.gov:	NCT04034316
EudraCT Nr.:	2018-001162-42