535 Participants Needed

TG-C for Osteoarthritis of the Knee

Recruiting at 100 trial locations
MW
MH
AH
DH
Overseen ByDiana Halim
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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 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.12345

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.678910

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.123411

Who Is on the Research Team?

MJ

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
See 12 more

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?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kolon TissueGene, Inc.

Lead Sponsor

Trials
6
Recruited
1,500+

Citations

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]
Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-β1. [2020]
Initial phase I safety of retrovirally transduced human chondrocytes expressing transforming growth factor-beta-1 in degenerative arthritis patients. [2021]
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]
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]
A glucuronated flavone TMMG spatially targets chondrocytes to alleviate cartilage degeneration through negative regulation of IL-1β. [2023]
Prognosis of Advanced Tenosynovial Giant Cell Tumor of the Knee Diagnosed During Total Knee Arthroplasty. [2022]
Progression of Knee Osteoarthritis With Use of Intraarticular Glucocorticoids Versus Hyaluronic Acid. [2023]
Galactosaminoglucuronoglycan sulphate in the treatment of osteoarthritis: clinical efficacy and tolerance of oral and intra-articular administrations. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Autologous Osteochondral Grafts for Knee Osteochondral Diseases Result in Good Patient-Reported Outcomes in Patients Older Than 60 Years. [2023]
Fresh Osteochondral Allograft Transplants in the Knee: Bipolar and Beyond. [2021]
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