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

NCT03291470 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: TGC-15302
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Degenerative Osteoarthritis

Keywords

knee

Outcome Measures

Primary Outcomes (2)

• Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)

  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.

  12 months

• Change in Knee Pain as Assessed by VAS

  Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.

  12 months

Secondary Outcomes (4)

• MRI Assessment of Target Knee

  12 months

• PCS of the SF-12 Questionnaire

  12 months

• WOMAC Total Score

  24 Months

• Health Assessment Questionnaire Disability Index

  12 months

Other Outcomes (6)

• Radiography for Structural Change in Knee Joint

  24 months

• Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score

  Week 1, Months 3, 6, 9, 12, 18, and 24

• Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores

  24 months

Study Arms (2)

Active Treatment (TG-C)

ACTIVE COMPARATOR

TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection

Biological: TG-C

Placebo Control (Normal Saline)

PLACEBO COMPARATOR

Normal saline, single 2 mL intraarticular injection

Biological: Placebo Control

Interventions

TG-C BIOLOGICAL

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

Also known as: TissueGene-C

Active Treatment (TG-C)

Placebo Control BIOLOGICAL

2 mL normal saline intraarticular injection

Also known as: Normal Saline

Placebo Control (Normal Saline)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40 or older
• BMI between 18.5 and 40
• KL Grade 2 or 3 knee OA
• OARSI Grade 1 or 2 medial JSN
• Pain \>= 40 on VAS scale
• Written informed consent
• Using birth control

You may not qualify if:

• Knee symptoms that result in difficulty or inability to walk
• Knee effusion \>2+
• Has Grade 3 OARSI JSN
• MRI exam indicates fracture or tumor
• Has a positive result on RCR testing at screening
• Has taken NSAIDS with 14 days of baseline
• Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months of baseline
• Chronic (\>21 days) narcotic use
• Recent history (within 1 year) of drug or alcohol abuse
• Pregnant or lactating
• Has received injection to target knee within 2 months prior to study entry
• History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
• Severe hip osteoarthritis ipsilateral to the target knee
• Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV.
• Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder.

Sponsors & Collaborators

• Kolon TissueGene, Inc.: lead

Study Sites (27)

Nebojsa Skrepnik

Tucson, Arizona, 85712, United States

Location

Steve Sitar

Anaheim, California, 92801, United States

Location

Stuart Silverman

Beverly Hills, California, 90211, United States

Location

Samy Metyas

Covina, California, 91722, United States

Location

Bassil Aish

Huntington Beach, California, 92647, United States

Location

Peter Hanson

La Mesa, California, 91942, United States

Location

Duane Anderson

San Diego, California, 92120, United States

Location

Miguel Trevino

Clearwater, Florida, 33756, United States

Location

Jan Hommen

Doral, Florida, 33126, United States

Location

Mira Baron

West Palm Beach, Florida, 33409, United States

Location

Richard Radnovich

Boise, Idaho, 83713, United States

Location

Thomas Schnitzer

Chicago, Illinois, 60611, United States

Location

Nathan Rimmke

Rochester Hills, Michigan, 48307, United States

Location

Larkin Wadsworth

St Louis, Missouri, 63141, United States

Location

Robby Ann Quintos

Las Vegas, Nevada, 89109, United States

Location

Igor Grosman

Brooklyn, New York, 11235, United States

Location

Jonathan Samuels

New York, New York, 10016, United States

Location

Minal Desai

Durham, North Carolina, 27704, United States

Location

Jeremy Hoff

Wilmington, North Carolina, 28412, United States

Location

Priyesh Mehta

Dayton, Ohio, 45432, United States

Location

Edward Tavel

Charleston, South Carolina, 29406, United States

Location

Durga Tanneru

Dallas, Texas, 75230, United States

Location

Manjoo Sharma

Lewisville, Texas, 75057, United States

Location

Haresh Boghara

Red Oak, Texas, 75154, United States

Location

Leonel Reyes

San Antonio, Texas, 78215, United States

Location

Lisa Blair

San Antonio, Texas, 78229, United States

Location

David Scott

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Moon Jong Noh, PhD

  Kolon TissueGene

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: December 9, 2021
• Primary Completion: March 6, 2024
• Study Completion: May 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)