TG-C for Knee Osteoarthritis

Recruiting at 68 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

531 Participants Needed

Trial Summary

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 TG-C safe for humans?

TG-C has been tested in clinical trials for knee osteoarthritis and is generally considered safe. Common side effects include joint pain, swelling, and injection site pain, but no severe adverse events were observed. ^{1 2 3 4 5}

How is the TG-C treatment for knee osteoarthritis different from other treatments?

TG-C is a novel cell and gene therapy that uses genetically engineered chondrocytes to overexpress transforming growth factor-β1 (TGF-β1), which helps reduce pain and inflammation while potentially slowing disease progression and improving cartilage structure, unlike standard treatments that mainly focus on symptom relief. ^{1 2 4 5 6}

What is the purpose of this trial?

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.

Research Team

Moon Jong Noh, PhD

Principal Investigator

Kolon TissueGene

Eligibility Criteria

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 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.

Knee effusion greater than 2+

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-β1. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 5% ibuprofen cream treatment in knee osteoarthritis. Results of a randomized, double-blind, placebo-controlled study. [2013]

4. England pubmed.ncbi.nlm.nih.gov

TissueGene-C induces long-term analgesic effects through regulation of pain mediators and neuronal sensitization in a rat monoiodoacetate-induced model of osteoarthritis pain. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

TissueGene-C promotes an anti-inflammatory micro-environment in a rat monoiodoacetate model of osteoarthritis via polarization of M2 macrophages leading to pain relief and structural improvement. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Long-Lasting Effects of "Placebo Injections" in Knee Osteoarthritis: A Meta-Analysis. [2022]