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

NCT03656575 | Completed Phase 1 FDA Drug

• 1 other identifier: 17-01551
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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)

  6 Weeks

• 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)

  3 Months

Study Arms (3)

intra-articular alpha-2-macroglobulin

ACTIVE COMPARATOR

intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)

Biological: synovial fluid biomarker concentrations

intra-articular Platelet-rich Plasma (PRP) injection

ACTIVE COMPARATOR

Standard of care PRP treatment

Biological: synovial fluid biomarker concentrations

Intra-articular corticosteroid

ACTIVE COMPARATOR

Standard of Care steroid treatment

Biological: synovial fluid biomarker concentrations

Interventions

synovial fluid biomarker concentrations BIOLOGICAL

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

Intra-articular corticosteroid; intra-articular Platelet-rich Plasma (PRP) injection; intra-articular alpha-2-macroglobulin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Laith Jazrawi, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: November 1, 2017
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)