NCT05079035

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: BioTissue Holdings, Inc · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Knee Osteoarthritis
• Knee Pain Chronic
• Knee Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	TTAX03	Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord
BIOLOGICAL	Saline	2 mL Sterile, preservative free 0.9% NaCl

Timeline

• Start date: 2021-12-06
• Primary completion: 2025-03-07
• Completion: 2025-03-07
• First posted: 2021-10-15
• Last updated: 2025-09-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study