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

NCT03203330 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TGC-12301
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 44

Brief Summary

A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy 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 (5)

• Radiography for Structural Change in Knee Joint

  Through 24 months

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

  At Months 3, 6, 9 and 18

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

  Through 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 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
• Has a score of 0 or \>=5 on the cartilage feature of the WORMS at Screening
• 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 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 OA, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
• Severe hip osteoarthritis ipsilateral to the target knee
• Ongoing infection disease including but not limited to HIV, Hepatitis B or C.

Sponsors & Collaborators

• Kolon TissueGene, Inc.: lead

Study Sites (44)

Jeffrey Davis

Birmingham, Alabama, 35205, United States

Location

Bradly Goodman

Birmingham, Alabama, 35235, United States

Location

Saima Chohan

Phoenix, Arizona, 85032, United States

Location

Nebojsa Skrepnik

Tucson, Arizona, 85712, United States

Location

Diraj Karnani

Apple Valley, California, 92307, United States

Location

Dan La

Covina, California, 91722, United States

Location

Scott Hacker

La Mesa, California, 91942, United States

Location

Eric Grigsby

Napa, California, 94558, United States

Location

Arthur Mabaquiao

San Diego, California, 92108, United States

Location

Timothy Davis

Santa Monica, California, 90403, United States

Location

Tien-I Su

Whittier, California, 90602, United States

Location

Mehul Desai

Washington D.C., District of Columbia, 20006, United States

Location

David Billmeier

Daytona Beach, Florida, 32117, United States

Location

Mercedes Ponce De Leon

Miami, Florida, 33135, United States

Location

Aurelio Torres-Consuegra

Miami, Florida, 33144, United States

Location

Edgar Gonzalez

Miami, Florida, 33144, United States

Location

Cathy Barnes

New Port Richey, Florida, 34652, United States

Location

Howard Chipman

Oldsmar, Florida, 34677, United States

Location

Richard Linn

Sunrise, Florida, 33351, United States

Location

Anand Patel

Winter Park, Florida, 32789, United States

Location

Sandeep Vaid

Newnan, Georgia, 30265, United States

Location

Dennis Levinson

Chicago, Illinois, 60607, United States

Location

Manish Jain

Chicago, Illinois, 60640, United States

Location

Hythem Shadid

Oak Brook, Illinois, 60523, United States

Location

Adil Fatakia

Marrero, Louisiana, 70072, United States

Location

James Nace

Baltimore, Maryland, 21215, United States

Location

Melvin Churchill

Lincoln, Nebraska, 68516, United States

Location

Jason Oh

New York, New York, 10075, United States

Location

Brett Gilbert

Durham, North Carolina, 27704, United States

Location

Jeremy Hoff

Wilmington, North Carolina, 28412, United States

Location

Yogesh Mittal

Tulsa, Oklahoma, 74104, United States

Location

Alan Kivitz

Duncansville, Pennsylvania, 16635, United States

Location

Edward Tavel

Columbia, South Carolina, 29206, United States

Location

Eric Loudermilk

Greenville, South Carolina, 29601, United States

Location

Harvey Bowles

Nashville, Tennessee, 37203, United States

Location

Daneshvari Solanki

Bellaire, Texas, 77401, United States

Location

Amr Morsy

Dallas, Texas, 75240, United States

Location

Haresh Boghara

DeSoto, Texas, 75115, United States

Location

Aldo Maspons

El Paso, Texas, 79225, United States

Location

Subodh Bhuchar

Houston, Texas, 77099, United States

Location

Brian MacGillivray

San Antonio, Texas, 78258, United States

Location

John Hemmersmeier

South Ogden, Utah, 84405, United States

Location

Kristen Holtz

Charlottesville, Virginia, 22901, United States

Location

Mark Hermann

Danville, Virginia, 24541, United States

Location

Related Publications (1)

• Mehta S, He T, Bajpayee AG. Recent advances in targeted drug delivery for treatment of osteoarthritis. Curr Opin Rheumatol. 2021 Jan;33(1):94-109. doi: 10.1097/BOR.0000000000000761.

  PMID: 33229973 DERIVED

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, Inc.

  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: June 21, 2017
• First Posted: June 29, 2017
• Study Start: October 30, 2018
• Primary Completion: July 10, 2024
• Study Completion (Estimated): July 10, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (44)