WHO ICTRP trial

A phase 2 study to evaluate the efficacy of allogeneic human cord blood-derived…

EUCTR2018-001162-42-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2018-001162-42-IT
Public title A phase 2 study to evaluate the efficacy of allogeneic human cord blood-derived mesenchymal stromal cells in pediatric patients with steroid-dependent nephrotic syndrome in maintaining remission after immunosuppressive therapy withdrawal
Scientific title A phase 2 open-label study to evaluate the efficacy of allogeneic human cord blood-derived mesenchymal stromal cells in maintaining remission after immunosuppressive therapy withdrawal in pediatric patients with steroid-dependent nephrotic syndrome - Reduce immunosuppression with Atmp in NS ChildrEn…
Primary sponsor FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions Steroid dependent nephrotic syndrome MedDRA version: 20.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Symptoms and…
Interventions Product Name: Cellule mesenchimali stromali di origine cordonale (CB-MSC) per uso allogenico) Product Code: CF-CB-MSC Pharmaceutical Form: Suspension for injection Current Sponsor code: CF-CB-MSC Concentration unit: Other Concentration…
Registration date Mar 14, 2019
Target size 11
Secondary IDs AIFA-2016-02364896
Registry page clinicaltrialsregister.eu

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