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.
Aged 18 to 80 years old
The subject has a diagnosis of Grade ≤2 primary OA of the target hip
Pain ≥ 40 on VAS scale
The subject has groin pain that is elicited by hip rotation on physical examination
The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.
The subject has severe hip OA ipsilateral to the target hip.
Previous cartilage transplantation procedure to the injured cartilage surface.
Major injury to the target hip within 12 months of screening.