Mesenchymal stromal cells for treatment of drug resistant pediatric Juvenile idiopathic arthritis
Phase 2
Completed
- Conditions
- juvenile idiopathic arthritis1000381610023213
- Registration Number
- NL-OMON39754
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients (4-18 years of age) diagnosed with juvenile idiopathic arthritis according to the ILAR-criteria with active arthritis resistant to intra-articular steroids and systemic use of methotrexate and for whom no on-label indication exists for (not yet used) biologicals. The patient is followed for adverse events via the Pharmachild database. Signed informed consent by the patient and/or parent(s) or legal guardian(s)
Exclusion Criteria
<4 or >18 years of age
Concurrent infection, febrile illness or malignancy.
Pregnancy.
Comedication: Biologic response modifiers.
Lack of written and verbal informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total number of adverse events in the 3 months prior to MSC infusion and the<br /><br>number of adverse events 3 months after MSC infusion.</p><br>
- Secondary Outcome Measures
Name Time Method