Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT05276011
PHASE2

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

Sponsor: Kolon TissueGene, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2025-10

Completion Date

2026-10

Last Updated

2024-12-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

TG-C

2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.

BIOLOGICAL

Placebo Control

2 mL normal saline injection