drugset / Trial / NCT05276011

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis

NCT05276011 ↗

Phase 2 Not yet recruiting 255 enrolled Kolon TissueGene, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.

Timeline

Start
2026-10
Primary completion
2027-10
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator TG-C Cell therapy 3e+06 cells Other
Comparator TG-C Cell therapy 1e+07 cells Other

Indications