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
- Conditions
- Steroid dependent nephrotic syndromeMedDRA version: 20.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2018-001162-42-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 11
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method