TG-C for Osteoarthritis of the Knee

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

535 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 the study and steroidal anti-inflammatory medications 2 months before the study. Chronic narcotic use is also not allowed.

What data supports the effectiveness of the treatment TG-C for osteoarthritis of the knee?

Research shows that TG-C significantly improves knee function and reduces pain in patients with knee osteoarthritis compared to a placebo. It also appears to slow down cartilage damage and inflammation, making it a promising treatment for managing osteoarthritis. ^{1 2 3 4 5}

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 5 6}

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

TG-C is unique because it is specifically designed for osteoarthritis of the knee, potentially offering a novel approach compared to traditional treatments like glucocorticoid injections or hyaluronic acid, which focus on reducing inflammation or lubricating the joint. While the exact mechanism of TG-C is not detailed, it may offer a new option for patients who do not respond well to existing therapies. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Moon Jong Noh, PhD

Principal Investigator

Kolon TissueGene, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

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. 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]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Initial phase I safety of retrovirally transduced human chondrocytes expressing transforming growth factor-beta-1 in degenerative arthritis patients. [2021]

4. 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]

5. 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]

6. France pubmed.ncbi.nlm.nih.gov

A glucuronated flavone TMMG spatially targets chondrocytes to alleviate cartilage degeneration through negative regulation of IL-1β. [2023]

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

Prognosis of Advanced Tenosynovial Giant Cell Tumor of the Knee Diagnosed During Total Knee Arthroplasty. [2022]

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

Progression of Knee Osteoarthritis With Use of Intraarticular Glucocorticoids Versus Hyaluronic Acid. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Galactosaminoglucuronoglycan sulphate in the treatment of osteoarthritis: clinical efficacy and tolerance of oral and intra-articular administrations. [2007]

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

Autologous Osteochondral Grafts for Knee Osteochondral Diseases Result in Good Patient-Reported Outcomes in Patients Older Than 60 Years. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Fresh Osteochondral Allograft Transplants in the Knee: Bipolar and Beyond. [2021]