TG-C for Knee Osteoarthritis

Not currently recruiting at 69 trial locations

Overseen By Aaron Harrison

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kolon TissueGene, Inc.

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

Disqualifiers: Rheumatoid arthritis, Diabetes, Cancer, 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 TG-C, a treatment for individuals with moderate knee osteoarthritis, to determine its effectiveness in reducing pain and improving joint function. Participants will receive either the TG-C injection or a placebo (a harmless substance with no treatment effect) and will be monitored for 24 months. It is suitable for those experiencing knee pain with a specific type of knee osteoarthritis. Participants should not have severe walking difficulties or recent treatments that could affect the trial's results. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

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 starting and steroidal anti-inflammatory or biologic therapy medications 2 months before starting. Chronic narcotic use is also not allowed.

Is there any evidence suggesting that TG-C is likely to be safe for humans?

Research has shown that TG-C is safe. Studies indicate that a single injection of TG-C into the knee is well-tolerated. Over 12 years of follow-up data reveal no major safety concerns. Only minor reactions, such as slight swelling or redness at the injection site, have been reported.

Long-term safety reviews have not identified any new issues. Even after more than a decade of follow-up, no new safety problems have emerged. Any reported unwanted effects align with expert expectations, indicating nothing unusual or alarming.

This suggests that TG-C is a well-tolerated treatment option for knee osteoarthritis, a type of arthritis affecting the knee joint. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for knee osteoarthritis, which typically include pain relievers and anti-inflammatory medications, TG-C stands out because it involves injecting a high concentration of therapeutic cells directly into the knee joint. This innovative approach utilizes a cell-based therapy, delivering 3 x 10e7 cells in a single 2 mL intraarticular injection, which could promote tissue repair and regenerate damaged cartilage. Researchers are excited about TG-C because it targets the root cause of joint degeneration rather than just alleviating symptoms, offering the potential for longer-lasting relief and improved joint function.

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

In this trial, participants will receive either TG-C or a placebo control. Studies have shown that TG-C can significantly improve pain and movement in people with knee osteoarthritis. Specifically, patients who received TG-C reported better results on a knee health score and a pain scale compared to those who did not receive it. The treatment also shows promise in delaying or even avoiding the need for surgery. Research indicates that TG-C is safe and helps reduce inflammation, which can prevent joint damage. Overall, TG-C appears to be an effective option for managing knee osteoarthritis. ^{1 6 7 8 9}

Who Is on the Research Team?

Moon Jong Noh, PhD

Principal Investigator

Kolon TissueGene

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), 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.

Inclusion Criteria

My knee joint space narrowing is mild to moderate.

I am 40 years old or older.

BMI between 18.5 and 40

Exclusion Criteria

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

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

Knee effusion greater than 2+

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 with assessments at various time points

24 months

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

Long-term Safety Follow-up

Annual cancer surveillance questionnaires through 15 years post dose 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 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.

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 ...

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

PR These findings suggest that TG-C may either replace or significantly delay the need for surgical intervention — a hallmark of a disease- ...

3. 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 ...

4. 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 ...

5. 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].

6. congress.oarsi.org congress.oarsi.org/program/sessions/theater-session-first-potential-dmoad-therapy-tg-c-intra-articular-cell-based-gene

Theater Session: The First Potential DMOAD Therapy, TG-C Annual safety data updates over the past five years have revealed no new safety signals to date, and AEs observed have been consistent with expectations in the ...

7. 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 ...

8. oarsijournal.com oarsijournal.com/article/S1063-4584(25)00397-8/pdf

LONG-TERM SAFETY OF TISSUEGENE-C (TG-C) No new safety signals or tolerability issues have emerged between the 2023 and 2024 analyses, even with the review of those followed for over 10 years. The ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3793276/

Initial phase I safety of retrovirally transduced human ... Conclusions. Overall, there were no significant safety issues related to the administration of TG-C, with only some minor injection site reactions observed. ...