OsteoarthritisNCT06227195
Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis
An observational study of Osteoarthritis and Knee Arthritis, run by Shufeng Li at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee Arthritis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with knee osteoarthritis come to our hospital
Who may be able to join
None listed.
Who cannot join
- Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
About this study
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
- Conditions
- Osteoarthritis, Knee Arthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Breg
Regulatory B cells
Measured: 4 and 8 weeks after DMM
Secondary outcomes (1)
Cytokine secretion by T cells
Regulatory T cells
Measured: 4 and 8 weeks after DMM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shufeng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shufeng Li, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227195
- Sponsor's protocol ID
- 2018S0097
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis
- ClinicalTrials.gov ID
- NCT06227195
- Acronym / sponsor ID
- 2018S0097
- Conditions
- Osteoarthritis, Knee Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shufeng LiUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis come to our hospital
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Breg
Time frame: 4 and 8 weeks after DMM
Regulatory B cells
1 secondary outcome
Cytokine secretion by T cells
Time frame: 4 and 8 weeks after DMM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Knee Arthritis, run by Shufeng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Breg (time frame: 4 and 8 weeks after DMM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.