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NCT03291470 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee
A Phase 3 study of Degenerative Osteoarthritis, sponsored by Kolon TissueGene.
- Active
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
- 20
- Study locations
NCT03291470: Active Phase 3 study of Degenerative Osteoarthritis, sponsored by Kolon TissueGene.
NCT03291470 is a Phase 3 study of Degenerative Osteoarthritis that is active but no longer recruiting, run by Kolon TissueGene. The registered enrollment target is 531 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03291470, a Phase 3 study of Degenerative Osteoarthritis, is active but no longer recruiting, sponsored by Kolon TissueGene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 531 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
Conditions Studied
Interventions
- BIOLOGICAL TG-C
- BIOLOGICAL Placebo Control
Study Locations (20)
California
- Steve Sitar - Anaheim
- Stuart Silverman - Beverly Hills
- Samy Metyas - Covina
- Bassil Aish - Huntington Beach
- Peter Hanson - La Mesa
- John Beckes - San Diego
Florida
- Miguel Trevino - Clearwater
- Jan Hommen - Doral
- Mira Baron - West Palm Beach
New York
- Igor Grosman - Brooklyn
- Jonathan Samuels - New York
North Carolina
- Minal Desai - Durham
- Jeremy Hoff - Wilmington
Arizona
- Nebojsa Skrepnik - Tucson
Idaho
- Richard Radnovich - Boise
Illinois
- Thomas Schnitzer - Chicago
Michigan
- Nathan Rimmke - Rochester Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 3 |
What the registry record for NCT03291470 still lists
NCT03291470 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Degenerative Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which TG-C is the first listed.
NCT03291470 names 20 study sites across 11 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03291470 about?
NCT03291470 is a clinical study titled "Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee". 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...
What is the current status of trial NCT03291470?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2021-12-09. Estimated completion is 2026-03-06.
What conditions does trial NCT03291470 study?
This clinical trial studies the following conditions: Degenerative Osteoarthritis.
What interventions are being tested in trial NCT03291470?
The interventions under investigation include: TG-C (BIOLOGICAL), Placebo Control (BIOLOGICAL).
Who is sponsoring clinical trial NCT03291470?
This trial is sponsored by Kolon TissueGene, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03291470 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03291470's enrollment target sits among peer trials
531 704th of 2000 higher than 1,295 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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