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OpenTrials
Completed

NCT Number: NCT06227195

Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis

Our previous work has shown that Treg function is impaired in OA patients, but the cause of Treg deficiency has not been investigated. Since Breg has been shown to promote Treg differentiation and tissue repair, it is highly likely that the absence of the immunomodulatory effect of Breg in OA patients leads to impaired Treg differentiation. Based on the above data, we hypothesized that Breg plays a protective role in the course of OA by regulating T cell composition and promoting Treg differentiation through the secretion of anti-inflammatory factor IL-10

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Arthritis Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who met the American College of Rheumatology diagnostic criteria for OA

-

Exclusion criteria

  • Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases

Treatment and study plan

Primary outcomes

  1. Number of Breg

    Time frame: 4 and 8 weeks after DMM

    Regulatory B cells

Secondary outcomes

  1. Cytokine secretion by T cells

    Time frame: 4 and 8 weeks after DMM

    Regulatory T cells

Sponsors and collaborators

Lead sponsor

Shufeng Li

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2024
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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