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Completed Phase 3 Interventional

Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee

ClinicalTrials.gov ID: NCT03291470

Public ClinicalTrials.gov record NCT03291470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 4:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.

Study identification

NCT ID
NCT03291470
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kolon TissueGene, Inc.
Industry
Enrollment
531 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 9, 2021 (Actual)
Primary completion
Mar 6, 2024 (Actual)
Completion
May 1, 2026 (Actual)
Last update posted
Aug 20, 2026

2021 – 2026

United States locations

U.S. sites
27
U.S. states
14
U.S. cities
26
Facility City State ZIP Site status
Nebojsa Skrepnik Tucson Arizona 85712 —
Steve Sitar Anaheim California 92801 —
Stuart Silverman Beverly Hills California 90211 —
Samy Metyas Covina California 91722 —
Bassil Aish Huntington Beach California 92647 —
Peter Hanson La Mesa California 91942 —
Duane Anderson San Diego California 92120 —
Miguel Trevino Clearwater Florida 33756 —
Jan Hommen Doral Florida 33126 —
Mira Baron West Palm Beach Florida 33409 —
Richard Radnovich Boise Idaho 83713 —
Thomas Schnitzer Chicago Illinois 60611 —
Nathan Rimmke Rochester Hills Michigan 48307 —
Larkin Wadsworth St Louis Missouri 63141 —
Robby Ann Quintos Las Vegas Nevada 89109 —
Igor Grosman Brooklyn New York 11235 —
Jonathan Samuels New York New York 10016 —
Minal Desai Durham North Carolina 27704 —
Jeremy Hoff Wilmington North Carolina 28412 —
Priyesh Mehta Dayton Ohio 45432 —
Edward Tavel Charleston South Carolina 29406 —
Durga Tanneru Dallas Texas 75230 —
Manjoo Sharma Lewisville Texas 75057 —
Haresh Boghara Red Oak Texas 75154 —
Leonel Reyes San Antonio Texas 78215 —
Lisa Blair San Antonio Texas 78229 —
David Scott Spokane Washington 99218 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03291470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 20, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03291470 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →