What side effects are associated with this type of intervention?

Common treatments for osteoarthritis involving intra-articular injections include glucocorticoids, hyaluronic acid, and platelet-rich plasma (PRP). Glucocorticoid injections can cause side effects such as joint infection, post-injection flare, and potential cartilage damage with repeated use. Hyaluronic acid injections may lead to local reactions like pain, swelling, and redness at the injection site. PRP injections are generally well-tolerated but can cause minor and transient effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site. All intra-articular injections carry a risk of local infection.

What prior FDA approvals exist?

Several treatments for osteoarthritis have been explored, including intra-articular injections aimed at reducing inflammation and promoting cartilage repair. Hyaluronic acid derivatives have been used, although evidence of their benefit is limited. Platelet-rich plasma (PRP) has shown promise in reducing inflammation and promoting tissue repair, but it is primarily used for musculoskeletal conditions and lacks major adverse events. Anti-NGF agents like tanezumab and fasinumab have shown efficacy in reducing pain and improving function but have raised safety concerns, including rapidly progressive osteoarthritis and increased joint replacements. These treatments highlight ongoing efforts to find effective intra-articular therapies for osteoarthritis.

What other types of research exist?

Promising novel alternatives to TG-C for osteoarthritis treatment include: 1) Intra-articular N-acetylglucosamine (GlcNAc), which has shown chondroprotective and anti-inflammatory activity, reducing cartilage degradation and suppressing synovitis. 2) Curcumin monoglucuronide (TBP1901), which has been effective in suppressing articular cartilage damage and regulating subchondral bone alteration. 3) Epigallocatechin (EGCG), which alters the biomechanical properties of articular cartilage through collagen crosslinking.

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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

Must not have

Severe hip osteoarthritis ipsilateral to the target knee

Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, months 3, 6, 9, 12, 18, and 24

Awards & highlights

Pivotal Trial

Summary

This trial tests TG-C, an injection into the knee, for people with moderate to severe knee osteoarthritis. It aims to see if TG-C can reduce pain and improve knee function by potentially altering the disease. The study will monitor patients for safety and effectiveness over time. TG-C has been previously studied for its potential to improve knee joint function and reduce pain in osteoarthritis patients.

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.

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.

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 below

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My knee joint space narrowing is mild to moderate.

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I am 40 years old or older.

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My knee arthritis is moderate to severe.

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My pain level is 40 or more on a scale of 0-100.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe hip arthritis on the same side as my affected knee.

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I do not have uncontrolled heart, liver, kidney, adrenal gland disorders, or thyroid issues.

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My knee joint space narrowing is severe.

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My MRI shows a fracture or tumor.

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I have knee problems that make it hard or impossible for me to walk.

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I have a history of knee disorders such as rheumatoid arthritis or gout.

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My screening test for the virus came back positive.

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I do not have any ongoing infectious diseases like HIV or hepatitis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, months 3, 6, 9, 12, 18, and 24 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

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 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 / 12Eligibility 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) include nonsteroidal anti-inflammatory drugs (NSAIDs) and intra-articular injections. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Intra-articular injections, like corticosteroids and hyaluronic acid, aim to reduce local inflammation and provide lubrication to the joint, respectively. Emerging treatments, such as TG-C, focus on delivering therapeutic agents directly into the joint to reduce inflammation and promote cartilage repair. These treatments are crucial for OA patients as they target the underlying inflammatory processes and aim to preserve joint function and delay disease progression.

Green tea polyphenol treatment is chondroprotective, anti-inflammatory and palliative in a mouse post-traumatic osteoarthritis model.Efficacy of intra-articular injection of celecoxib in a rabbit model of osteoarthritis.