Back to resultsReduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
synovial fluid biomarker concentrations
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3
Exclusion Criteria:
- Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age
- Greater than 90 years of age
- Patients with underlying inflammatory arthropathies
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
intra-articular alpha-2-macroglobulin
intra-articular Platelet-rich Plasma (PRP) injection
Intra-articular corticosteroid
Arm Description
intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)
Standard of care PRP treatment
Standard of Care steroid treatment
Outcomes
Primary Outcome Measures
Measure of synovial fluid biomarker levels
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Measure of synovial fluid biomarker levels
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03656575
Brief Title
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
Official Title
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intra-articular alpha-2-macroglobulin
Arm Type
Active Comparator
Arm Description
intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)
Arm Title
intra-articular Platelet-rich Plasma (PRP) injection
Arm Type
Active Comparator
Arm Description
Standard of care PRP treatment
Arm Title
Intra-articular corticosteroid
Arm Type
Active Comparator
Arm Description
Standard of Care steroid treatment
Intervention Type
Biological
Intervention Name(s)
synovial fluid biomarker concentrations
Intervention Description
Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year
Primary Outcome Measure Information:
Title
Measure of synovial fluid biomarker levels
Description
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Time Frame
6 Weeks
Title
Measure of synovial fluid biomarker levels
Description
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3
Exclusion Criteria:
Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Greater than 90 years of age
Patients with underlying inflammatory arthropathies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laith Jazrawi, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
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