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Not Yet Recruiting NCT05276011

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

Conditions: Degenerative Osteoarthritis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 255
Sponsor: Kolon TissueGene, Inc.

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.

Eligibility Criteria

Inclusion Criteria: * 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 * No history of significant organ system disorders. * Body mass index (BMI) \8% at the screening Visit. * Increased risk for post-procedure bleeding or post-procedure infection. * Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B. * Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires. * 1 year history of drug or alcohol abuse. * Contraindication to or cannot undergo MRI. * Active malignancy within the last 5 years. * Pregnant or is lactating. * Taken steroidal or NSAIDs within 14 days before the Baseline Visit * Using topical analgesics on the target hip * Receiving chronic narcotic treatment at screening. * Received any injection to the target hip within the 3 months before the Baseline Visit. * Taking antiplatelet or anticoagulants. * Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months. * Unable to comply with the requisite study follow-up and all of the follow-up office visits.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05276011). StuddyBuddy aggregates publicly available trial information.