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NCT03656575 · ClinicalTrials.gov registry record · Phase 1

Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin

A Phase 1 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 1
Development phase
75
Enrollment target

NCT03656575 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 75 participants.

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The verdict

NCT03656575, a Phase 1 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target

Study Summary

The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee. This is a double-blinded rationalized control trial with prospective data collection. The study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular PR injection and intra-articular corticosteroid serving as a control. Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes will be assessed after six weeks and three months.

Interventions

  • BIOLOGICAL synovial fluid biomarker concentrations

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2017-11-01
Est. Completion 2019-04-20
Phase Phase 1

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT03656575

The ClinicalTrials.gov registry entry for NCT03656575 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which synovial fluid biomarker concentrations is the first listed.

NCT03656575 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03656575 about?

NCT03656575 is a clinical study titled "Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin". The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee. This is a double-blinded rationalized control trial with prospective data collection. The study...

What is the current status of trial NCT03656575?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2017-11-01. Estimated completion is 2019-04-20.

What interventions are being tested in trial NCT03656575?

The interventions under investigation include: synovial fluid biomarker concentrations (BIOLOGICAL).

Who is sponsoring clinical trial NCT03656575?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.