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NCT06227195 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06227195
Other study ID # 2018S0097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information
Verified date January 2024
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The First Affiliated Hospital of Shandong First Medical University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shufeng Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Breg Regulatory B cells 4 and 8 weeks after DMM
Secondary Cytokine secretion by T cells Regulatory T cells 4 and 8 weeks after DMM
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