Mesenchymal stromal cells for treatment of drug resistantpediatric juvenile idiopathic arthritis

Recruiting

Conditions: juvenile idiopathic arthritis

Registration Number: NL-OMON21350

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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.

Exclusion Criteria

Concurrent use of biological response modifiers.

Concurrent infection, febrile illness or malignancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of adverse events in the 3 months prior to MSC infusion and the number of adverse events 3 months after MSC infusion.<br /><br>To offer an effective alternative for that category of JIA patients that is therapy-resistant.<br /><br>For this effectiveness the ACR Pediatric 70 criteria should be achieved.<br /><br>The ACR Pedi 70 criteria are defined as improvement of >= 70% in at least 3 of 6 core response variables used to assess disease activity with no more than 1 variable worsening by >= 30%.<br>

Secondary Outcome Measures

Name	Time	Method
- The ACR Pediatric 30 criteria should be met.<br /><br>The ACR Pedi 30 criteria are defined as improvement of ≥ 30% in at least 3 of 6 core response variables used to assess disease activity with no more than 1 variable worsening by ≥ 30%.<br>Core response variables are:<br /><br>1. Physician global assessment of overall disease activity<br /><br>2. Parent or patient global assessment of overall well-being<br /><br>3. Functional ability (CHAQ)<br /><br>4. Number of joints with active arthritis<br /><br>5. Number of joints with limited range of motion<br /><br>6. Index of inflammation: ESR or CRP<br><br /><br /><br>- Radiological (MRI) improvement of most active large joint.<br /><br>- Improvement in laboratory parameters or biomarkers.<br>