Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA

Knee Osteoarthritis Clinical Trial

Official title: A Phase 2, 52-Week Trial of TTAX03 vs. Saline as a Single Intra-articular Injection in Kellgren-Lawrence Grade 3-4 Knee OA

Status Active, not recruiting

Clinical Trial Summary

It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of responders 12 weeks post-injection than an equal volume of saline, based on the OMERACT-OARSI responder criteria.

Clinical Trial Description

This trial is designed as a Phase 2 randomized, placebo controlled, double-blinded parallel design to be conducted at multiple sites throughout North America. One dose level of TTAX03 (100 mg) will be tested against an equal volume of saline, which is the suspension vehicle (i.e., excipient). Each subject will receive a single IA injection into the knee under local anesthesia, with two safety follow-up visits in the first eight days and a third at the end of two weeks post injection. Subsequent visits will occur at the end of 6 and 12 weeks for evaluation of response, with the end of 12 weeks being the primary endpoint. Additional visits will occur at 6, 9 and 12 months (end of weeks 26, 39, 52) to evaluate duration of benefit and overall impression of change from baseline, as well as safety. The primary endpoint will be assessed at 12 weeks post receiving the assigned Intra-articular injection. ;

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT05079035
• Study type: Interventional
• Source: Tissue Tech Inc.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 6, 2021
• Completion date: March 1, 2025