What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs (e.g., ibuprofen, naproxen) and intra-articular glucocorticoid injections, are associated with several side effects. NSAIDs can cause gastrointestinal issues, including ulcers and bleeding, as well as cardiovascular risks like myocardial infarction. Intra-articular glucocorticoid injections may lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. Therapeutic agents like TG-C, which aim to reduce inflammation and promote cartilage repair, may have side effects such as injection site pain, swelling, and potential allergic reactions. It is important to discuss these risks with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis that aim to reduce inflammation and promote cartilage repair. These include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, which are commonly used for pain relief. Intra-articular injections of corticosteroids are also approved for short-term pain relief in OA patients. Additionally, hyaluronic acid injections have been used to provide lubrication and cushioning in the joint, although their efficacy is debated. More recently, treatments like intra-articular sprifermin have shown promise in reducing cartilage loss and promoting cartilage gain. These treatments share similarities with TG-C, which is being studied for its potential to repair damaged cartilage and reduce inflammation in knee OA.

What other types of research exist?

Promising novel alternatives to TG-C for osteoarthritis treatment include: 1) Lorecivivint, which has shown statistically significant improvements in patient-reported outcomes such as WOMAC pain and function scores in clinical trials. 2) Platelet-rich plasma (PRP), which provides high concentrations of growth factors to reduce inflammation and promote tissue repair, though its efficacy is still under investigation. 3) Intra-articular sprifermin, which has demonstrated the ability to reduce cartilage loss and increase cartilage gain in clinical trials. These alternatives offer potential benefits in managing OA symptoms and improving joint health.

← Back to Search

Other

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

Pivotal Trial

Summary

This trial tests TG-C, an injection into the knee, for patients with moderate to severe osteoarthritis. It aims to reduce pain and improve knee function by potentially modifying the disease. TG-C has shown promise in previous studies for managing knee osteoarthritis.

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.

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.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 3, 6, 9 and 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Change in Knee Pain as Assessed by VAS

Secondary study objectives

Health Assessment Questionnaire Disability Index

MRI Assessment of Target Knee

PCS of the SF-12 Questionnaire

+1 more

Other study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Osteoarthritis (OA) focus on reducing inflammation and promoting cartilage repair. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Intraarticular glucocorticoids provide short-term pain relief by reducing local inflammation. Platelet-rich plasma (PRP) injections aim to enhance tissue repair by delivering high concentrations of growth factors that promote cartilage regeneration. Investigational treatments like TG-C, administered via intraarticular injection, are designed to reduce inflammation and potentially stimulate cartilage repair, offering a targeted approach to managing OA symptoms and slowing disease progression. These mechanisms are crucial for OA patients as they address both pain management and the underlying joint damage, improving overall joint function and quality of life.

Medical ozone therapy as a potential treatment modality for regeneration of damaged articular cartilage in osteoarthritis.