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TG-C for Knee Osteoarthritis
Phase 3
Waitlist Available
Led By David W Romness, MD
Research Sponsored by Kolon TissueGene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
OARSI Grade 1 or 2 medial JSN
Aged 40 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, months 3, 6, 9, 12, 18, and 24
Awards & highlights
Study Summary
This trial is testing a new drug, TG-C, to see if it is effective and safe for treating osteoarthritis 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), experiencing significant pain. Participants must have a BMI between 18.5 and 40, use birth control, and not have severe joint issues, uncontrolled diabetes, recent cancer (except certain skin cancers), infections like HIV/HBV/HCV, or be using certain medications.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of TG-C compared to a placebo in improving knee osteoarthritis symptoms. TG-C is given as a single injection under ultrasound guidance. Patients are monitored over two years to see how well it works and any side effects.See study design
What are the potential side effects?
While specific side effects of TG-C aren't listed here, common risks may include pain at the injection site, allergic reactions, infection risk increase due to the procedure itself, and potential unknown long-term effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee joint space narrowing is mild to moderate.
Select...
I am 40 years old or older.
Select...
My knee arthritis is moderate to severe.
Select...
My pain level is 40 or more on a scale of 0-100.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, months 3, 6, 9, 12, 18, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, months 3, 6, 9, 12, 18, and 24
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
Efficacy of TG-C with Regard to Knee Function via VAS Pain Score
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
+3 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
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Who is running the clinical trial?
Kolon TissueGene, Inc.Lead Sponsor
5 Previous Clinical Trials
903 Total Patients Enrolled
4 Trials studying Osteoarthritis
879 Patients Enrolled for Osteoarthritis
Moon Jong Noh, PhDStudy ChairKolon TissueGene
3 Previous Clinical Trials
789 Total Patients Enrolled
2 Trials studying Osteoarthritis
765 Patients Enrolled for Osteoarthritis
David W Romness, MDPrincipal InvestigatorCommonwealth Orthopedics
1 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Osteoarthritis
102 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe hip arthritis on the same side as my affected knee.I do not have uncontrolled heart, liver, kidney, adrenal gland disorders, or thyroid issues.My knee joint space narrowing is mild to moderate.My knee joint space narrowing is severe.My MRI shows a fracture or tumor.I have knee problems that make it hard or impossible for me to walk.I have had an injection in my knee within the last 2 months.I have had cancer other than minor skin cancers or benign moles in the last 5 years.I am 40 years old or older.I have used steroidal or biologic therapy within the last 2 months.My pain level is 40 or higher on a scale of 0-100.My knee arthritis is moderate to severe.I have taken NSAIDs in the last 14 days.My pain level is 40 or more on a scale of 0-100.I have a history of knee disorders such as rheumatoid arthritis or gout.My screening test for the virus came back positive.I do not have any ongoing infectious diseases like HIV or hepatitis.
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: NCT03291470 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals does this research project hope to achieve?
"The primary outcome metric for this 12-month clinical trial will be the Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC). Additionally, researchers will be measuring the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI), physical component score (PCS) of the SF-12v2 questionnaire, and target knee symptoms, joint pain, and functionality assessed using the IKDC Subjective knee evaluation."
Answered by AI
What harmful side-effects have been reported with Active Treatment (TG-C)?
"Active Treatment (TG-C) has been given a safety score of 3 by our experts at Power. This is because it is a Phase 3 trial, meaning that there is both clinical evidence of its efficacy as well as extensive data supporting its safety."
Answered by AI
Are there any available vacancies for volunteers in this research?
"This research is presently looking for individuals to participate, as noted on clinicaltrials.gov. The listing for this study was first uploaded on December 9th, 2021 and was modified September 2nd, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
Other
Arizona
What site did they apply to?
Investigative Site
John Tesser
Ankit Patel
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
I am experiencing more pain than usual. I want to stop the progression of my disease if possible.
PatientReceived 2+ prior treatments
I have the symptoms and I've been diagnosed with osteoarthritis. Osteo arthritis and knee pain in right knee. Its affecting my pickleball and hiking.
PatientReceived no prior treatments
Multiple yrs symptoms both knees, L>R. 8 prior knee arthroscopies, 4 prior PRP Rx. Very active for age 75.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Details of trial drug? How long are the trials and what do they involve?
PatientReceived 1 prior treatment
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