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 - RACE

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO0 个研究点目标入组 11 人开始时间: 2019年3月14日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1.Age between 3 and 18 years;
•2.Clinical diagnosis of SDNS;
•3.Disease remission maintained by chronic therapy (at least 6 months) with either:
•-Use of a combination of 2 or more immunosuppressive drugs
•-use of 1 of the calcineurin inhibitors (Cyclosporin or Tacrolimus);
•4.Absence of proteinuria (PrU/CrU < 0.2 mg/mg) for at least 1 month;
•5.eGFR greater than or equal to 70 ml/min/1.73 m^2;
•6.Written informed consent from parents or guardians and the child when possible.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Age < 3 years or = 19 years;
•2.Resistant/refractory NS;
•3.Presence of genetic mutations associated with NS;
•4.eGFR less than 70 ml/min/1.73m^2;
•5.Thrombophilic condition;
•6.Pregnancy or lactating;
•7.Evidence of an uncooperative attitude;
•8.Any evidence that the patient will be unable to complete the trial follow-up.

发起方