Evaluating Allocetra Injections Compared to Placebo for Adults 64 and Older with Moderate to Severe Primary Knee Osteoarthritis

What this Trial Is About

This trial focuses on adults aged 64 and older who have moderate-to-severe primary knee osteoarthritis, a condition where joint cartilage breaks down and causes chronic inflammation and pain. The study evaluates the effects of Allocetra, an immunomodulatory cell-based therapy, compared to a placebo. Allocetra consists of specially modified allogeneic blood cells designed to reprogram immune cells and potentially reduce inflammation in the knee joint. Participants are randomly assigned to receive either Allocetra or a placebo through three ultrasound-guided injections into the affected knee on Days 0, 14, and 28. The study lasts for 12 months, with follow-up visits to monitor outcomes over this period. The trial is double-blind, meaning neither participants nor researchers know who receives Allocetra or placebo during the study. During the trial, participants will have assessments including pain and function evaluations using the Western Ontario and McMaster Universities Arthritis Index WOMAC at 3 and 6 months. Safety monitoring will continue for six months. Other measures such as quality of life and daily pain scores will also be collected. The study aims to understand Allocetras impact on knee osteoarthritis symptoms and safety over one year of observation.

Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis