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, Milano

Project Period:

11/2018   -   12/2021

Sponsors:

Non-profit foundation

ClinicalTrials.gov:

NCT04034316

EudraCT Nr.:

2018-001162-42

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