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Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis — A2MRP  

Osteoarthritis Clinical Trial

Official title:
Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP), Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis: A Pilot Study

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).

Clinical Trial Description

The overall objective of this study is to test and quantify A2MRP and prepare for a larger randomized clinical trial assessing the efficacy of A2MRP injections in primary and post traumatic knee osteoarthritis (OA) with respect to clinical outcomes and disease progression. The study will also assess safety of A2MRP intraarticular injection in patients with symptomatic knee OA. Patients with symptomatic mild to moderate knee OA (KL 2-3) will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), and radiologic exam of the knee will be obtained. All injections will be performed using ultrasound guidance and all patients will followed-up at week 1 week post-injection for acute adverse events (AEs). Each subject will be clinically followed-up for study endpoints using a predetermined protocol. PROs will be collected during the study period pre-procedure, and at 1, 2, and 6 weeks, 3-, 6-, 9- and 12-months post-procedure (Specific PRO's and timepoints noted in sections 6.2-6.7). Subjects will also be asked questions regarding satisfaction with the treatment and whether they would recommend the treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06329492
Study type Interventional
Source Mayo Clinic
Contact
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date January 9, 2024
Completion date December 31, 2025
View Details
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