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TG-C for Osteoarthritis of the Knee
Verified Trial
Phase 3
Recruiting
Research Sponsored by Kolon TissueGene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI between 18.5 and 40
KL Grade 2 or 3 knee OA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at months 3, 6, 9 and 18
Awards & highlights
Study Summary
This trial will test the safety and efficacy of TG-C, given by intra-articular injection, in patients with OA of the knee.
Who is the study for?
This trial is for adults aged 40 or older with moderate knee osteoarthritis (Grade 2 or 3), not too thin or overweight, and experiencing significant pain. Participants must consent to the study's terms and use birth control if applicable. Exclusions include severe knee swelling, certain MRI findings, recent injections in the knee, other serious health conditions, drug/alcohol abuse history, and specific medications taken recently.Check my eligibility
What is being tested?
The study tests TG-C's safety and effectiveness against a placebo in improving knee osteoarthritis symptoms. TG-C is given as a one-time injection into the affected joint under ultrasound guidance. The trial will follow patients for two years to see how well it works compared to a dummy treatment.See study design
What are the potential side effects?
While side effects are not detailed here, typical risks of intra-articular injections may include pain at the injection site, infection risk increase due to needle insertion into the joint space, allergic reactions to components of TG-C or potential systemic effects depending on its nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your body mass index (BMI) is within a healthy range, not too low or too high.
Select...
I have moderate to severe knee arthritis.
Select...
My knee joint space narrowing is mild to moderate.
Select...
My pain level is 40 or higher on a scale of 0-100.
Select...
I am 40 years old or older.
Select...
My pain level is 40 or more on a scale of 0 to 100.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at months 3, 6, 9 and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months 3, 6, 9 and 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
Change in Knee Pain as Assessed by VAS
Secondary outcome measures
Health Assessment Questionnaire Disability Index
MRI Assessment of Target Knee
PCS of the SF-12 Questionnaire
+1 moreOther outcome measures
Knee
Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores
Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Treatment (TG-C)Active Control1 Intervention
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Group II: Placebo Control (Normal Saline)Placebo Group1 Intervention
Normal saline, single 2 mL intraarticular injection
Find a Location
Who is running the clinical trial?
Kolon TissueGene, Inc.Lead Sponsor
5 Previous Clinical Trials
904 Total Patients Enrolled
4 Trials studying Osteoarthritis
880 Patients Enrolled for Osteoarthritis
Moon Jong Noh, PhDStudy ChairKolon TissueGene, Inc.
3 Previous Clinical Trials
790 Total Patients Enrolled
2 Trials studying Osteoarthritis
766 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee joint space narrowing is mild to moderate.My knee arthritis is moderate to severe.You have given your written informed consent to participate in this study.I am 40 years old or older.My pain level is 40 or more on a scale of 0 to 100.Your body mass index (BMI) is within a healthy range, not too low or too high.I do not have uncontrolled heart, liver, kidney, adrenal gland disorders, or thyroid issues.Your body mass index (BMI) falls between 18.5 and 40.I have moderate to severe knee arthritis.Your body mass index (BMI) should be between 18.5 and 40, which is a measure of your weight in relation to your height.You are currently using birth control to prevent pregnancy.I am 40 years old or older.My pain level is 40 or higher on a scale of 0-100.I have knee problems that make it hard or impossible for me to walk.My knee joint space narrowing is mild to moderate.You are using a method of preventing pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment (TG-C)
- Group 2: Placebo Control (Normal Saline)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03203330 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why did researchers design this experiment in this way?
"The primary outcome that will be measured to assess the efficacy of this treatment intervention over a one year period is change in knee pain as assessed by VAS. Additionally, the WOMAC Total Score (which evaluates knee function), MRI assessment of target knee (to look for features of OA), and PCS of the SF-12 Questionnaire (physical component score measuring HRQoL) will be used as secondary measures."
Answered by AI
Just wondering, how many test subjects are you all the way through with?
"In order to carry out this experiment, 510 eligible participants are needed. The sponsor, Kolon TissueGene, Inc., has chosen multiple sites including Investigative Site in Lincoln, Nebraska and The Center for Pharmaceutical Research in Kansas City, Missouri."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
Pennsylvania
Arizona
Other
How old are they?
65+
What site did they apply to?
Investigative Site
Amr Morsy
Mehul Desai
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+
Why did patients apply to this trial?
i need relief. I have arthritis. I would like the pain to stop. I would like to be without pain.
PatientReceived 1 prior treatment
Orthovisc has only worked so-so in the past.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What is the compensation? How long does the screening take? How many visits to the trial site are required?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
Most responsive sites:
- Adil Fatakia: < 24 hours
- Cathy Barnes: < 24 hours
- Tandem Clinical Research - Metairie, LA: < 48 hours
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