Evaluation of the treatment with blood cells in patients with Behçet Disease

Evaluation of the action of the treatment with platelet rich plasma in patients with Behçet Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-22z3jy

Enrollment

Unknown

Registered

2019-01-08

Start date

2014-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Behçet disease

Interventions

Eight patients were treated. Patients received 9 periumbilical injections of autologous platelet-rich plasma (P-PRP) during 6 months of treatment. Which presented 3.0 ML of volume. In the first 3 mont

Biological/vaccine

N77.8

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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). Data attached as graph.	—

Measure

Time frame

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 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). Data attached as graph.

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Countries

Brazil

Contacts

Public ContactStephany Huber

Universidade Estadual de Campinas

stephany_huber@yahoo.com.br+551935218755

Outcome results

None listed

Source: REBEC (via WHO ICTRP)