Evaluation of the treatment with blood cells in patients with Behçet Disease
Phase 2
- Conditions
- Patients with Behçet diseaseM35.2
- Registration Number
- RBR-22z3jy
- Lead Sponsor
- niversidade Estadual de Campinas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Confirmed diagnosis of Behçet disease according to established criteria according International Study Group for Behçet Disease (ISGBD); Minimum recurrence of three episodes of disease activity in the last year; presence of oral/genital ulcers, without corticosteroid use or at most with 10 mg daily (prednisone).
Exclusion Criteria
The exclusion criteria were: involvement of the central nervous system and/or ocular picture in activity, hematological or renal alterations; antecedent of Neoplasia in the last 5 year; use of corticosteroids in daily doses above 10 mg and use of anticoagulants.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in the frequency / intensity of Behçet disease activity, verified by less clinical symptons of the disease, evaluated by score (BR-BDCAF) and number of oral ulcers (questionnaire).Decrease is more evidente in the application period of the platelet rich plasma (6 months)
- Secondary Outcome Measures
Name Time Method Increase of regulatory T cells and decrease of inflammatory cells (activated NK cells and T lymphocytes, evaluated through flow cytometry), which is related to disease activity, and decrease of pro-inflammatory interleukins, evaluated by multiplex. These findings were more evident in the application period and follow-up of the patients;Expected and found outcomes<br><br>Significant decrease in the number of oral ulcers during the application period, as well as the time (in days) for closure of the lesions. Increase of regulatory T cells during the period of application and significant decrease of activated NK cells (marker of disease activity).<br>Data attached as graph.