TG-C for Osteoarthritis of the Knee

Not currently recruiting at 100 trial locations

Overseen By Diana Halim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kolon TissueGene, Inc.

Must not be taking: NSAIDs, Steroids, Narcotics, others

Disqualifiers: Knee disorders, Infections, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TG-C for knee osteoarthritis, a painful joint condition. The study aims to determine if TG-C, administered through a single ultrasound-guided injection, can safely reduce pain and improve knee function compared to a placebo (inactive treatment). Researchers will monitor participants for two years to assess the treatment's effectiveness and safety. The trial seeks individuals aged 40 or older with moderate knee osteoarthritis and significant knee pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for knee osteoarthritis.

Will I have to stop taking my current medications?

The trial requires that you stop taking NSAIDs (non-steroidal anti-inflammatory drugs) 14 days before the study and steroidal anti-inflammatory medications 2 months before the study. Chronic narcotic use is also not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TG-C is generally safe for treating knee osteoarthritis. Earlier studies reported no treatment-related tumors, indicating good safety. A long-term follow-up over 12 years found that a single injection of TG-C was safe and well-tolerated. Although some unexpected side effects occurred, they were not serious enough to outweigh the benefits, such as improved knee function and reduced pain. Overall, the evidence strongly supports the safety of TG-C for use in the knee joint. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Most treatments for osteoarthritis of the knee, such as NSAIDs and corticosteroid injections, focus on reducing pain and inflammation. But TG-C works differently, targeting the underlying problem by delivering live cells directly into the joint. These cells have the potential to repair cartilage, which could provide longer-lasting relief and possibly slow the progression of the disease. Researchers are excited about TG-C because it opens up a new avenue for not just managing symptoms, but potentially altering the course of osteoarthritis itself.

What evidence suggests that TG-C might be an effective treatment for osteoarthritis of the knee?

Research has shown that TG-C, which participants in this trial may receive, offers promising results for knee osteoarthritis. Studies found that patients who received TG-C experienced significant improvements in pain and movement, allowing them to feel less pain and move more easily. The treatment involves an injection directly into the knee joint, which may also help slow the disease's progression. Early findings suggest that TG-C is both effective and safe for people with knee osteoarthritis. ^{3 5 6 7 8}

Who Is on the Research Team?

Moon Jong Noh, PhD

Principal Investigator

Kolon TissueGene, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

OARSI Grade 1 or 2 medial JSN

KL Grade 2 or 3 knee OA

You have been diagnosed with Knee Osteoarthritis

Exclusion Criteria

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of TG-C or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy after treatment

24 months

Regular visits at Day 1, Week 1, and Months 1, 3, 6, 9, 12, 18, and 24

Long-term follow-up

Annual cancer surveillance questionnaires through 15 years post dosing for subjects not in the Long Term Safety study

15 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Control
• TG-C

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Treatment (TG-C) Active Control 1 Intervention

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

Group II: Placebo Control (Normal Saline) Placebo Group 1 Intervention

Normal saline, single 2 mL intraarticular injection

Who Is Running the Clinical Trial?

Kolon TissueGene, Inc.

Lead Sponsor

Trials

6

Recruited

1,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29641281/

A Multicenter, Double-Blind, Phase III Clinical Trial to ... TG-C was associated with statistically significant improvements in function and pain in patients with knee osteoarthritis. The unexpected adverse events were ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03291470

NCT03291470 | Study to Determine the Efficacy and Safety ... 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 ...

3. tissuegene.com tissuegene.com/en_US/clinical-trials

Clinical Trials :: Kolon TissueGene, Inc. (950160) The US Phase II study for TG-C was designed as a multi-center, double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of TG-C.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1465324924009319

TissueGene-C induces anti-inflammatory activity and M2 ... The clinical data available thus far have demonstrated that this drug is safe and improves pain and function in knee OA patients [12,13]. Furthermore, pre- ...

5. liebertpub.com liebertpub.com/doi/10.1089/humc.2017.249

A Multicenter, Double-Blind, Phase III Clinical Trial to ... Injection of TG-C into the knee joints of osteoarthritis patients resulted in clinically significant improvements in the IKDC and VAS when compared to patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03203330

A Study to Determine the Safety and Efficacy of TG-C in ... 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 ...

7. tissuegene.com tissuegene.com/ko/investors/pr/detail/33/kolon-tissuegene-highlights-long-term-safety-data-and

PR Safety Results: No treatment-related tumor cases were reported in TG-C ... data presented strongly supports the safety and efficacy of TG-C. We ...

8. oarsijournal.com oarsijournal.com/article/S1063-4584(21)00375-7/fulltext

Safety of TG-C: 12 years of follow-up safety data from ... Conclusions: The Results of placebo-controlled trials demonstrate that a single intra-articular injection of TG-C into the knee joint is safe and well tolerated ...