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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Knee symptoms that result in difficulty or inability to walk.
  • - Knee effusion >2+ - Has Grade 0 OARSI JSN or atrophic OA.
  • - Has a score of >=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.
  • - Clinically significant congestive heart failure hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder.
- Uncontrolled diabetes based on a HbA1c > 8% at screening

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03203330
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kolon TissueGene, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Moon Jong Noh, PhD
Principal Investigator Affiliation Kolon TissueGene, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Osteoarthritis
Additional Details

This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is intended for the treatment of patients with KL Grade 2 and 3 osteoarthritis and OARSI JSN Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS), function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This is a placebo-controlled study, TG-C will be compared to normal saline as a control. Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 24 months for both safety and efficacy with annual cancer surveillance questionnaires through 15 years post dosing for subjects who do not enroll in the Long Term Safety study.

Arms & Interventions

Arms

Active Comparator: Active Treatment (TG-C)

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

Placebo Comparator: Placebo Control (Normal Saline)

Normal saline, single 2 mL intraarticular injection

Interventions

Biological: - TG-C

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

Biological: - Placebo Control

2 mL normal saline injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jeffrey Davis, Birmingham, Alabama

Status

Not yet recruiting

Address

Jeffrey Davis

Birmingham, Alabama, 35205

Bradly Goodman, Birmingham, Alabama

Status

Recruiting

Address

Bradly Goodman

Birmingham, Alabama, 35235

Saima Chohan, Phoenix, Arizona

Status

Recruiting

Address

Saima Chohan

Phoenix, Arizona, 85032

Dan La, Covina, California

Status

Not yet recruiting

Address

Dan La

Covina, California, 91722

Scott Hacker, La Mesa, California

Status

Not yet recruiting

Address

Scott Hacker

La Mesa, California, 91942

Eric Grigsby, Napa, California

Status

Not yet recruiting

Address

Eric Grigsby

Napa, California, 94558

Louis Levy, San Diego, California

Status

Recruiting

Address

Louis Levy

San Diego, California, 92108

Timothy Davis, Santa Monica, California

Status

Recruiting

Address

Timothy Davis

Santa Monica, California, 90403

Charles Weidmann, Van Nuys, California

Status

Not yet recruiting

Address

Charles Weidmann

Van Nuys, California, 90602

Tien-I Su, Whittier, California

Status

Recruiting

Address

Tien-I Su

Whittier, California, 90602

Mercedes Ponce De Leon, Miami, Florida

Status

Recruiting

Address

Mercedes Ponce De Leon

Miami, Florida, 33135

Aurelio Torres-Consuegra, Miami, Florida

Status

Recruiting

Address

Aurelio Torres-Consuegra

Miami, Florida, 33144

Edgar Gonzalez, Miami, Florida

Status

Not yet recruiting

Address

Edgar Gonzalez

Miami, Florida, 33144

Cathy Barnes, New Port Richey, Florida

Status

Recruiting

Address

Cathy Barnes

New Port Richey, Florida, 34652

Anand Patel, Winter Park, Florida

Status

Recruiting

Address

Anand Patel

Winter Park, Florida, 32789

Dennis Levinson, Chicago, Illinois

Status

Not yet recruiting

Address

Dennis Levinson

Chicago, Illinois, 60607

Manish Jain, Chicago, Illinois

Status

Recruiting

Address

Manish Jain

Chicago, Illinois, 60640

Hythem Shadid, Oak Brook, Illinois

Status

Not yet recruiting

Address

Hythem Shadid

Oak Brook, Illinois, 60523

Adil Fatakia, Marrero, Louisiana

Status

Recruiting

Address

Adil Fatakia

Marrero, Louisiana, 70072

Ronald Delanois, Baltimore, Maryland

Status

Recruiting

Address

Ronald Delanois

Baltimore, Maryland, 21215

Melvin Churchill, Lincoln, Nebraska

Status

Recruiting

Address

Melvin Churchill

Lincoln, Nebraska, 68516

Elena Katzap, Great Neck, New York

Status

Not yet recruiting

Address

Elena Katzap

Great Neck, New York, 11021

Corey Hunter, New York, New York

Status

Recruiting

Address

Corey Hunter

New York, New York, 10022

Jason Oh, New York, New York

Status

Recruiting

Address

Jason Oh

New York, New York, 10075

John Solic, Raleigh, North Carolina

Status

Recruiting

Address

John Solic

Raleigh, North Carolina, 27612

Steven Folkerth, Dayton, Ohio

Status

Not yet recruiting

Address

Steven Folkerth

Dayton, Ohio, 45417

Alan Kivitz, Duncansville, Pennsylvania

Status

Recruiting

Address

Alan Kivitz

Duncansville, Pennsylvania, 16635

Javad Parvizi, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Javad Parvizi

Philadelphia, Pennsylvania, 19107

Thomas Ellis, State College, Pennsylvania

Status

Recruiting

Address

Thomas Ellis

State College, Pennsylvania, 16801

Edward Tavel, Columbia, South Carolina

Status

Recruiting

Address

Edward Tavel

Columbia, South Carolina, 29206

Shailesh Patel, North Charleston, South Carolina

Status

Recruiting

Address

Shailesh Patel

North Charleston, South Carolina, 29406

Jason Haslam, Nashville, Tennessee

Status

Not yet recruiting

Address

Jason Haslam

Nashville, Tennessee, 37203

Amr Morsy, Dallas, Texas

Status

Recruiting

Address

Amr Morsy

Dallas, Texas, 75240

Aldo Maspons, El Paso, Texas

Status

Recruiting

Address

Aldo Maspons

El Paso, Texas, 79225

Subodh Bhuchar, Houston, Texas

Status

Recruiting

Address

Subodh Bhuchar

Houston, Texas, 77099

David Jack, Draper, Utah

Status

Recruiting

Address

David Jack

Draper, Utah, 84020

John Hemmersmeier, South Ogden, Utah

Status

Recruiting

Address

John Hemmersmeier

South Ogden, Utah, 84405